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Title: Development, feasibility, and efficacy of decision aids to improve decision-making for post-mastectomy breast reconstruction: A systematic review and meta-analysis Open Access Deposited

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Methodology
  • Broad literature searches were run in several databases. Duplicate citations were removed in Endnote X6 (Clarivate Analytics). The remaining citations were imported into DistillerSR (Evidence Partners, Inc.) for study selection. Data was extracted from the final set of included studies. Statistical analyses were performed using RevMan5.
Description
  • This systematic review and meta-analysis assesses decision aids in the context of patients considering post-mastectomy breast reconstruction.

  • NOTE: An updated Read Me file was added to this data set on May 24, 2018 replacing the original.
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Depositor
  • markmac@umich.edu
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Keyword
Citations to related material
  • Berlin NL, Tandon VJ, Hawley ST, et al. Feasibility and Efficacy of Decision Aids to Improve Decision Making for Postmastectomy Breast Reconstruction: A Systematic Review and Meta-analysis. Med Decis Making. 2019;39(1):5–20. https://doi.org/10.1177/0272989X18803879
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  • On January 31, 2020, Citation for related publication was added to record metadata.
Last modified
  • 02/03/2020
Published
  • 03/23/2018
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DOI
  • https://doi.org/10.7302/Z2XP734R
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To Cite this Work:
Berlin, N., MacEachern, M. (2018). Development, feasibility, and efficacy of decision aids to improve decision-making for post-mastectomy breast reconstruction: A systematic review and meta-analysis [Data set], University of Michigan - Deep Blue Data. https://doi.org/10.7302/Z2XP734R

Files (Count: 17; Size: 17.5 MB)

Record #1 of 90
ID: CN-01112825
AU: Causarano N
AU: Platt J
AU: Baxter NN
AU: Bagher S
AU: Jones JM
AU: Metcalfe KA
AU: Hofer SO
AU: O'Neill AC
AU: Cheng T
AU: Starenkyj E
AU: Zhong T
TI: Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.
SO: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
YR: 2015
VL: 23
NO: 5
PG: 1365-75
PM: PUBMED 25351455
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [surgery];Decision Making;Decision Support Techniques;Health Knowledge, Attitudes, Practice;Informed Consent;Mammaplasty [education];Mastectomy;Patient Education as Topic;Physician-Patient Relations;Pilot Projects;Referral and Consultation;Self Efficacy;Surveys and Questionnaires;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1007/s00520-014-2479-6
AB: PURPOSE: Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction.METHODS: We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT.RESULTS: Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06.CONCLUSIONS: A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/825/CN-01112825/frame.html

Record #2 of 90
ID: CN-01368609
AU: Sherman KA
AU: Shaw LK
AU: Winch CJ
AU: Harcourt D
AU: Boyages J
AU: Cameron LD
AU: Brown P
AU: Lam T
AU: Elder E
AU: French J
AU: Spillane A
TI: Reducing Decisional Conflict and Enhancing Satisfaction with Information among Women Considering Breast Reconstruction following Mastectomy: results from the BRECONDA Randomized Controlled Trial
SO: Plastic and reconstructive surgery
YR: 2016
VL: 138
NO: 4
PG: 592e-602e
PM: PUBMED 27673530
PT: Journal Article; Multicenter Study; Randomized Controlled Trial
KY: Decision Making;Decision Support Techniques;Follow-Up Studies;Internet;Mammaplasty [psychology];Mastectomy;Outcome Assessment (Health Care);Patient Education as Topic;Patient Participation [methods] [psychology];Patient Satisfaction [statistics & numerical data];Single-Blind Method;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1097/PRS.0000000000002538
AB: METHODS: Women (n = 222) diagnosed with breast cancer or ductal carcinoma in situ, and eligible for reconstruction following mastectomy, completed an online baseline questionnaire. They were then assigned randomly to receive either standard online information about breast reconstruction (control) or standard information plus access to BRECONDA (intervention). Participants then completed questionnaires at 1 and 6 months after randomization. The primary outcome was participants' decisional conflict 1 month after exposure to the intervention. Secondary outcomes included decisional conflict at 6 months, satisfaction with information at 1 and 6 months, and 6-month decisional regret.RESULTS: Linear mixed-model analyses revealed that 1-month decisional conflict was significantly lower in the intervention group (27.18) compared with the control group (35.5). This difference was also sustained at the 6-month follow-up. Intervention participants reported greater satisfaction with information at 1- and 6-month follow-up, and there was a nonsignificant trend for lower decisional regret in the intervention group at 6-month follow-up. Intervention participants' ratings for BRECONDA demonstrated high user acceptability and overall satisfaction.CONCLUSIONS: Women who accessed BRECONDA benefited by experiencing significantly less decisional conflict and being more satisfied with information regarding the reconstruction decisional process than women receiving standard care alone. These findings support the efficacy of BRECONDA in helping women to arrive at their breast reconstruction decision.BACKGROUND: Deciding whether or not to have breast reconstruction following breast cancer diagnosis is a complex decision process. This randomized controlled trial assessed the impact of an online decision aid [Breast RECONstruction Decision Aid (BRECONDA)] on breast reconstruction decision-making.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/609/CN-01368609/frame.html

Record #3 of 90
ID: CN-00481444
AU: Roosmalen MS
AU: Stalmeier PF
AU: Verhoef LC
AU: Hoekstra-Weebers JE
AU: Oosterwijk JC
AU: Hoogerbrugge N
AU: Moog U
AU: Daal WA
TI: Randomized trial of a shared decision-making intervention consisting of trade-offs and individualized treatment information for BRCA1/2 mutation carriers
SO: Journal of clinical oncology
YR: 2004
VL: 22
NO: 16
PG: 3293-3301
PM: PUBMED 15310772
PT: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [genetics] [psychology] [surgery];DNA Mutational Analysis;Decision Making;Decision Support Techniques;Genes, BRCA1;Genes, BRCA2;Genetic Predisposition to Disease;Genetic Testing;Life Expectancy;Mastectomy;Ovarian Neoplasms [genetics] [surgery];Patient Education as Topic;Patient Participation;Patient Satisfaction;Quality of Life;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-GYNAECA
DOI: 10.1200/JCO.2004.05.066
AB: PATIENTS AND METHODSThe SDMI consisted of two value assessment sessions, using the time trade-off method, followed by individualized treatment information based on (quality-adjusted) life expectancy. After the baseline assessment (2 weeks after a positive DNA test result), women were randomly assigned to the SDMI group (n = 44), receiving the SDMI 2 months after the test result, or to the control group (n = 44). The short- and long-term effects, 3 and 9 months after the test result, were assessed using questionnaires. Data were collected on well-being, treatment choice, and decision-related outcomes.RESULTSIn the short term, the SDMI had no effect. In the long term, with respect to well-being, patients in the SDMI group had less intrusive thoughts (P =.05) and better general health (P =.01) and tended to be less depressed (P =.07). With respect to decision-related outcomes for the breasts, the SDMI group held stronger preferences (P =.02) and agreed more strongly to having weighed the pros and cons (P =.01). No effect was found on treatment choice. In the long term, interaction effects between the SDMI and cancer history were found. The SDMI showed an overall beneficial effect for unaffected women, whereas affected women tended to experience detrimental effects.CONCLUSIONWe conclude that the SDMI improved decision making in unaffected BRCA1/2 mutation carriers. Supporting decision making in a systematic way using trade-offs is beneficial for these women.PURPOSETo evaluate a shared decision-making intervention (SDMI) for BRCA1/2 mutation carriers who have to make a choice between screening and prophylactic surgery for breasts and/or ovaries.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/444/CN-00481444/frame.html

Record #4 of 90
ID: CN-00482845
AU: Whelan T
AU: Levine M
AU: Willan A
AU: Gafni A
AU: Sanders K
AU: Mirsky D
AU: Chambers S
AU: O'Brien MA
AU: Reid S
AU: Dubois S
TI: Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial
SO: JAMA
YR: 2004
VL: 292
NO: 4
PG: 435-441
PM: PUBMED 15280341
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [surgery];Decision Making;Decision Support Techniques;General Surgery;Health Knowledge, Attitudes, Practice;Mastectomy;Mastectomy, Segmental;Patient Education as Topic;Patient Participation;Patient Satisfaction;Physician-Patient Relations;Referral and Consultation;Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA
DOI: 10.1001/jama.292.4.435
AB: OBJECTIVETo evaluate the impact of a decision aid regarding the different surgical treatment options on patient decision making.DESIGN AND SETTINGA cluster randomized trial for which general surgeons in the communities of central-west, and eastern Ontario, Canada, were randomly assigned to use the decision aid or not in the surgical consultation. Patients received the decision aid or not based on the surgeon seen.PARTICIPANTSTwenty surgeons participated in the study. Of the 208 eligible women with newly diagnosed clinical stage I or II breast cancer seen by study surgeons, 201 agreed to be evaluated: 94 were assigned to the decision board and 107 to usual practice. Patients were recruited from November 1999 to April 2002.INTERVENTIONThe decision board is a decision aid designed to help physicians inform their patients about different treatment options and to enable patients to express a preference for treatment.MAIN OUTCOME MEASURESPatient knowledge about the surgical treatment of breast cancer; decisional conflict; satisfaction with decision making; and the treatment decision following the consultation.RESULTSPatients in the decision board group had higher knowledge scores about their treatment options (66.9 vs 58.7; P<.001), had less decisional conflict (1.40 vs 1.62, P =.02), and were more satisfied with decision making (4.50 vs 4.32, P =.05) following the consultation. Patients who used the decision board were more likely to choose BCT (94% vs 76%, P =.03).CONCLUSIONSThe decision board was helpful in improving communication and enabling women to make a choice regarding treatment. Such instruments should be considered by surgeons when communicating the different surgical options to women with breast cancer.CONTEXTThe long-term results of randomized trials have demonstrated equivalent survival rates for mastectomy and breast-conserving therapy for the treatment of early stage breast cancer. Consequently, the choice of treatment should be based on a patient's preferences.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/845/CN-00482845/frame.html

Record #5 of 90
ID: CN-00813311
AU: Jibaja-Weiss ML
AU: Volk RJ
AU: Granchi TS
AU: Neff NE
AU: Robinson EK
AU: Spann SJ
AU: Aoki N
AU: Friedman LC
AU: Beck JR
TI: Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy
SO: Patient education and counseling
YR: 2011
VL: 84
NO: 1
PG: 41-48
PM: PUBMED 20609546
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [diagnosis] [psychology] [surgery];Computer-Assisted Instruction [methods];Decision Support Techniques;Educational Status;Follow-Up Studies;Health Knowledge, Attitudes, Practice;Health Literacy;Hospitals, Public;Mastectomy;Multimedia;Patient Education as Topic [methods];Patient Participation [methods] [psychology];Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1016/j.pec.2010.06.009
AB: METHODSNewly diagnosed female patients with early stage breast cancer from two public hospitals were randomized to receive an entertainment-based decision aid for breast cancer treatment along with usual care (intervention arm) or to receive usual care only (control arm). Pre-decision (baseline), pre-surgery, and 1-year follow-up assessments were conducted.RESULTSPatients assigned to the intervention arm of the study were more likely than the controls to choose mastectomy rather than breast-conserving surgery; however, they appeared better informed and clearer about their surgical options than women assigned to the control group. No differences in satisfaction with the surgical decision or the decision-making process were observed between the patients who viewed the intervention and those assigned to the control group.CONCLUSIONSEntertainment education may be a desirable strategy for informing lower health literate women about breast cancer surgery options.PRACTICE IMPLICATIONSIncorporating patient decision aids, particularly computer-based decision aids, into standard clinical practice remains a challenge; however, patients may be directed to view programs at home or at public locations (e.g., libraries, community centers).OBJECTIVETo evaluate an entertainment-based patient decision aid for early stage breast cancer surgery in low health literacy patients.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/311/CN-00813311/frame.html

Record #6 of 90
ID: CN-00650907
AU: Heller L
AU: Parker PA
AU: Youssef A
AU: Miller MJ
TI: Interactive digital education aid in breast reconstruction
SO: Plastic and reconstructive surgery
YR: 2008
VL: 122
NO: 3
PG: 717-724
PM: PUBMED 18766034
XR: EMBASE 355000702
PT: Journal Article; Randomized Controlled Trial
KY: Anxiety [prevention & control];CD-I;Decision Making;Mammaplasty;Patient Education as Topic [methods];Patient Satisfaction;Patients [psychology];Prospective Studies;Female[checkword];Humans[checkword];Middle Aged[checkword];anxiety; article; breast cancer/su [Surgery]; *breast reconstruction; cancer patient; cancer surgery; clinical assessment; computer program; consultation; controlled study; *educational technology; female; health education; human; *interactive digital education aid; knowledge; learning; major clinical study; medical decision making; medical information; patient education; patient satisfaction; plastic surgery; preoperative care; priority journal; prospective study; questionnaire
DOI: 10.1097/PRS.0b013e318180ed06
AB: METHODSBreast cancer patients who were candidates for breast reconstruction were recruited and randomized into a control group and a study group. Both groups received routine assessment and education in the plastic surgery clinic, but the study group also watched the interactive digital education aid. Questionnaires assessing knowledge, anxiety, and satisfaction were administered (1) before the initial plastic surgery consultation, (2) immediately before surgery, and (3) 1 month after surgery.RESULTSA total of 133 women participated, 66 in the control group and 67 in the study group. Women in both groups showed decreased anxiety, increased knowledge, and enhanced satisfaction with their decision-making ability associated with preoperative instructions about reconstructive surgery. However, the study group was significantly more satisfied than the control group with the method of receiving information and showed a less steep learning curve regarding the different techniques of breast reconstruction. They also tended to have a reduced mean level of anxiety and increased satisfaction with the treatment choice compared with the control group.CONCLUSIONSAn interactive digital education aid is a beneficial educational adjunct for patients contemplating breast reconstruction. Patients who use an interactive digital education aid demonstrate greater factual knowledge, reduced anxiety, and increased postoperative satisfaction compared with patients given preoperative instructions using standard methods alone. The benefit of an interactive digital education aid is expected to be higher in a broad-based practice setting outside of a comprehensive cancer center.BACKGROUNDAn interactive digital education aid for breast reconstruction patients was developed because of a perceived need to provide patients with more education regarding the treatment so that they can make better informed treatment decisions. A prospective randomized study was conducted to assess its effectiveness.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/907/CN-00650907/frame.html

Record #7 of 90
ID: CN-00963222
AU: Platt J
AU: Baxter N
AU: Jones J
AU: Metcalfe K
AU: Causarano N
AU: Hofer SO
AU: O'Neill A
AU: Cheng T
AU: Starenkyj E
AU: Zhong T
TI: Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.
SO: Trials
YR: 2013
VL: 14
PG: 199
PM: PUBMED 23829442
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Implantation;Breast Neoplasms [diagnosis] [psychology] [surgery];Clinical Protocols;Decision Making;Feasibility Studies;Health Knowledge, Attitudes, Practice;Mastectomy;Ontario;Patient Education as Topic;Patient Participation;Patient Satisfaction;Pilot Projects;Referral and Consultation;Research Design;Self Efficacy;Treatment Outcome;Female[checkword];Humans[checkword]
DOI: 10.1186/1745-6215-14-199
AB: BACKGROUND: The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.METHODS/DESIGN: This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada.Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired.Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.DISCUSSION: Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.TRIAL REGISTRATION: NCT01857882.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/222/CN-00963222/frame.html

Record #8 of 90
ID: CN-00473290
AU: Roosmalen MS
AU: Stalmeier PF
AU: Verhoef LC
AU: Hoekstra-Weebers JE
AU: Oosterwijk JC
AU: Hoogerbrugge N
AU: Moog U
AU: Daal WA
TI: Randomised trial of a decision aid and its timing for women being tested for a BRCA1/2 mutation
SO: British journal of cancer
YR: 2004
VL: 90
NO: 2
PG: 333-342
PM: PUBMED 14735173
PT: Clinical Trial; Journal Article; Randomized Controlled Trial
KY: Attitude to Health;Breast Neoplasms [genetics] [pathology] [surgery];DNA Mutational Analysis;Decision Making;Decision Support Techniques;Genes, BRCA1;Genes, BRCA2;Genetic Counseling;Genetic Predisposition to Disease;Genetic Testing;Mastectomy;Pamphlets;Patient Education as Topic;Prognosis;Risk Factors;Time Factors;Video Recording;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-COMMUN
DOI: 10.1038/sj.bjc.6601525
AB: The aim of the study was to evaluate the impact of a decision aid (DA) and its timing in women being tested for a BRCA1/2 mutation. Women with and without a previous history of cancer were included after blood sampling for genetic testing. The DA consisted of a brochure and video providing information on screening and prophylactic surgery. To evaluate the impact of the DA, women were randomised to the DA group (n=184), receiving the DA 2 weeks after blood sampling, or to the control group (n=184). To evaluate the impact of timing, mutation carriers who had received the DA before the test result (n=47) were compared to mutation carriers who received the DA after the test result (n=42). Data were collected on well-being, treatment choice, decision and information related outcomes. The impact of the DA was measured 4 weeks after blood sampling. The impact of timing was measured 2 weeks after a positive test result. The DA had no impact on well-being. Regarding decision related outcomes, the DA group more frequently considered prophylactic surgery (P=0.02) corroborated with higher valuations (P=0.04). No differences were found for the other decision related outcomes. Regarding information related outcomes, the DA group felt better informed (P=0.00), was more satisfied with the information (P=0.00), and showed more accurate risk perceptions. Timing of the DA had no effect on any of the outcomes. No interactions were found between the DA and history of cancer. In conclusion, women being tested for a BRCA1/2 mutation benefit from the DA on information related outcomes. Because timing had no effect, the DA is considered useful either before or after the test result.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/290/CN-00473290/frame.html

Record #9 of 90
ID: CN-00960642
AU: Lam WW
AU: Chan M
AU: Or A
AU: Kwong A
AU: Suen D
AU: Fielding R
TI: Reducing treatment decision conflict difficulties in breast cancer surgery: a randomized controlled trial.
SO: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
YR: 2013
VL: 31
NO: 23
PG: 2879-85
PM: PUBMED 23835709
XR: EMBASE 23835709
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [pathology] [psychology] [surgery];Decision Making;Decision Support Techniques;Neoplasm Staging;Patient Education as Topic [methods];Patient Satisfaction;Surveys and Questionnaires;Treatment Outcome;Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA
DOI: 10.1200/JCO.2012.45.1856
AB: PURPOSE: Breast cancer (BC) decision aid (DA) randomized studies are limited to DA use in consultations among Western populations and for primary surgery. Their effectiveness beyond consultations, for reconstructive surgery and in other populations, has not been evaluated. We developed a DA administered after consultation for Chinese women deciding on BC surgery and, where relevant, immediate breast reconstruction, which was evaluated in this randomized controlled trial (RCT).PATIENTS AND METHODS: Overall, 276 women considering BC surgery for early-stage BC were randomly assigned to receive a DA (take-home booklet) or the standard information booklet (control condition) after the initial consultation, wherein surgeons disclosed the diagnosis and discussed treatment options with patients. Using block random assignment by week, 138 women were assigned to the DA arm and 138 to the control arm. Participants completed interview-based questionnaires 1 week after consultation and then 1, 4, and 10 months after surgery. Primary outcome measures were decisional conflict, decision-making difficulties, BC knowledge 1 week after consultation, and decision regret 1 month after surgery. Secondary outcome measures were treatment decision, decision regret 4 and 10 months after surgery, and postsurgical anxiety and depression.RESULTS: The DA group reported significantly lower decisional conflict scores 1 week after consultation (P = .016) compared with women in the control arm. Women receiving the DA had significantly lower decision regret scores 4 (P = .026) and 10 months (P = .014) after surgery and lower depression scores 10 months after surgery (P = .001).CONCLUSION: This RCT demonstrated DAs may benefit Chinese patients in Hong Kong by reducing decisional conflict and subsequent regret and enhance clinical services for this population.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/642/CN-00960642/frame.html

Record #10 of 90
ID: CN-00431263
AU: Whelan T
AU: Sawka C
AU: Levine M
AU: Gafni A
AU: Reyno L
AU: Willan A
AU: Julian J
AU: Dent S
AU: Abu-Zahra H
AU: Chouinard E
AU: Tozer R
AU: Pritchard K
AU: Bodendorfer I
TI: Helping patients make informed choices: a randomized trial of a decision aid for adjuvant chemotherapy in lymph node-negative breast cancer
SO: Journal of the national cancer institute
YR: 2003
VL: 95
NO: 8
PG: 581-587
PM: PUBMED 12697850
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Antineoplastic Agents [administration & dosage];Breast Neoplasms [drug therapy] [pathology] [surgery] [therapy];Chemotherapy, Adjuvant;Decision Making;Decision Support Techniques;Follow-Up Studies;Lymphatic Metastasis;Mastectomy [methods];Neoplasm Recurrence, Local;Patient Participation;Patient Satisfaction;Surveys and Questionnaires;Treatment Outcome;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-CANCER: SR-COMMUN: SR-EPOC
AB: METHODSBetween October 1995 and March 2000, 176 women with lymph node-negative breast cancer who were candidates for adjuvant chemotherapy were randomly assigned to receive the Decision Board plus the medical consultation (83 patients) or the medical consultation alone (93 patients). One week after the consultation, patients completed a questionnaire assessing their knowledge about breast cancer and chemotherapy. Satisfaction with decision making was assessed 1 week and 3, 6, and 12 months after randomization, and differences between groups were analyzed by a repeated measures analysis of variance. All statistical tests were two-sided.RESULTSPatients in the Decision Board arm were better informed about breast cancer and adjuvant chemotherapy than patients in the control arm (mean knowledge score = 80.2 [on a scale of 0-100], 95% confidence interval [CI] = 77.1 to 83.3, and 71.7, 95% CI = 69.0 to 74.4, respectively; P<.001). Over the entire study period, satisfaction with decision making was higher for patients in the Decision Board arm than for patients in the control arm (P =.032). There was no statistically significant difference between the two groups in the number of patients who chose adjuvant chemotherapy (77% and 70% for patients in the Decision Board arm and those in the control arm, respectively; P =.303).CONCLUSIONWhen making decisions regarding adjuvant chemotherapy, patients with early breast cancer who had been exposed to the Decision Board had better knowledge of the disease and treatment options and greater satisfaction with their decision making than those who received the standard consultation.BACKGROUNDIn recent years, patients have indicated a desire for more information about their disease and to be involved in making decisions about their care. We developed an aid called the "Decision Board" to help clinicians inform patients with lymph node-negative breast cancer of the risks and benefits of adjuvant chemotherapy. We determined whether adding the Decision Board to the medical consultation improved patient knowledge and satisfaction compared with the medical consultation alone.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/263/CN-00431263/frame.html

Record #11 of 90
ID: CN-00730633
AU: Sheppard VB
AU: Williams KP
AU: Harrison TM
AU: Jennings Y
AU: Lucas W
AU: Stephen J
AU: Robinson D
AU: Mandelblatt JS
AU: Taylor KL
TI: Development of decision-support intervention for Black women with breast cancer.
SO: Psycho-oncology
YR: 2010
VL: 19
NO: 1
PG: 62-70
PM: PUBMED 19267384
PT: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
KY: African Continental Ancestry Group [psychology];Attitude to Health;Breast Neoplasms [ethnology] [pathology] [psychology] [therapy];Chemotherapy, Adjuvant [psychology];Communication;Decision Making;Mastectomy [psychology];Mastectomy, Segmental [psychology];Motivation;Neoplasm Staging;Patient Acceptance of Health Care [psychology];Patient Education as Topic;Patient Satisfaction;Physician-Patient Relations;Pilot Projects;Radiotherapy, Adjuvant [psychology];Social Support;Spirituality;Survivors [psychology];Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA
DOI: 10.1002/pon.1530
AB: BACKGROUND: Adjuvant therapy improves breast cancer survival but is underutilized by Black women. Few interventions have addressed this problem. This preliminary report describes the process we used to develop a decision-support intervention for Black women eligible for adjuvant therapy. Aims were to use qualitative methods to describe factors that influence Black women's adjuvant therapy decisions, use these formative data to develop messages for a treatment decision-support intervention, and pilot test the acceptability and utility of the intervention with community members and newly diagnosed women. METHODS: Thirty-four in-depth interviews were conducted with breast cancer patients in active treatment, survivors and cancer providers to gather qualitative data. Participant ages ranged from 38 to 69 years. A cultural framework was used to analyze the data and to inform intervention messages. Most women relied on their providers for treatment recommendations. Several women reported problems communicating with providers and felt unprepared to ask questions and discuss adjuvant treatment options. Other factors related to treatment experiences were: spiritual coping, collectivism and sharing breast cancer experiences with other Black survivors. RESULTS: Using these formative data, we developed an intervention that is survivor-based and includes an in-person session which incorporates sharing personal stories, communication skills training and decision support. Intervention materials were reviewed by community members, researchers/clinicians and patients newly diagnosed with breast cancer. CONCLUSION: Patients reported satisfaction with the intervention and felt better prepared to talk with providers. The intervention will be tested in a randomized trial to enhance decision support and increase use of indicated adjuvant treatment.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/633/CN-00730633/frame.html

Record #12 of 90
ID: CN-01169461
AU: Berger-Höger B
AU: Liethmann K
AU: Mühlhauser I
AU: Haastert B
AU: Steckelberg A
TI: Informed shared decision-making supported by decision coaches for women with ductal carcinoma in situ: study protocol for a cluster randomized controlled trial
SO: Trials
YR: 2015
VL: 16
PG: 452
PM: PUBMED 26458964
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Attitude of Health Personnel;Breast Neoplasms [diagnosis] [nursing] [psychology] [therapy];Carcinoma, Intraductal, Noninfiltrating [diagnosis] [psychology] [therapy];Choice Behavior;Communication;Decision Support Techniques;Germany;Health Knowledge, Attitudes, Practice;Informed Consent;Nurse-Patient Relations;Patient Education as Topic;Patient Participation;Physician-Patient Relations;Research Design;Female[checkword];Humans[checkword]
DOI: 10.1186/s13063-015-0991-8
AB: METHODS/DESIGN: A cluster randomized controlled trial will be conducted to compare the informed shared decision-making program with standard care. The program comprises an evidence-based patient decision aid and training of physicians (2 hours) and specialized breast care and oncology nurses (4 days) in informed shared decision-making. Sixteen certified breast care centers will be included, with 192 women with primary DCIS being recruited. Primary outcome is the extent of patients' involvement in shared decision-making as assessed by the MAPPIN-Odyad (Multifocal approach to the 'sharing' in shared decision-making: observer instrument dyad). Secondary endpoints include the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), informed choice, decisional conflict and the duration of encounters. It is expected that decision coaching and the provision of evidence-based patient decision aids will increase patients' involvement in decision-making with informed choices and reduce decisional conflicts and duration of physician encounters. Furthermore, an accompanying process evaluation will be conducted.DISCUSSION: To our knowledge, this is the first study investigating the implementation of decision coaches in German breast care centers.TRIAL REGISTRATION: Current Controlled Trials ISRCTN46305518 , date of registration: 5 June 2015.BACKGROUND: Women with breast cancer want to participate in treatment decision-making. Guidelines have confirmed the right of informed shared decision-making. However, previous research has shown that the implementation of informed shared decision-making is suboptimal for reasons of limited resources of physicians, power imbalances between patients and physicians and missing evidence-based patient information. We developed an informed shared decision-making program for women with primary ductal carcinoma in situ (DCIS). The program provides decision coaching for women by specialized nurses and aims at supporting involvement in decision-making and informed choices. In this trial, the informed shared decision-making program will be evaluated in breast care centers.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/461/CN-01169461/frame.html

Record #13 of 90
ID: CN-01121926
AU: Shaffer VA
AU: Hulsey L
AU: Zikmund-Fisher BJ
TI: The effects of process-focused versus experience-focused narratives in a breast cancer treatment decision task.
SO: Patient education and counseling
YR: 2013
VL: 93
NO: 2
PG: 255-64
PM: PUBMED 23962673
PT: Journal Article; Randomized Controlled Trial
KY: Breast Neoplasms [psychology] [surgery];Decision Making;Decision Support Techniques;Information Seeking Behavior;Mastectomy [psychology];Mastectomy, Segmental [psychology];Narration;Patient Satisfaction;United States;Videotape Recording;Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1016/j.pec.2013.07.013
AB: OBJECTIVE: To examine the effect of patient narratives that discuss decision processes versus patient experiences on decisions about treatments for early stage breast cancer.METHODS: We recruited 300 women with no previous history of breast cancer to imagine that they had been diagnosed with early stage breast cancer and to choose between mastectomy and lumpectomy with radiation. Before learning about their treatment options, participants were randomly assigned to one of four conditions with videotaped stories from fictitious cancer survivors, using a 2 (content: experience versus process) × 2 (emotional valence: positive only vs. positive and negative) factorial design, or a control condition with no stories. We measured information search, treatment intentions, and decision satisfaction.RESULTS: Participants viewing process narratives spent more time searching for information. Participants viewing experience narratives reported a greater ability to imagine what it was like to experience the treatments; they also evaluated their decision more positively on several dimensions.CONCLUSIONS: Process narratives appeared to guide information search, and experience narratives improved evaluations of the decision process.PRACTICE IMPLICATIONS: There is no evidence that process and experience narratives 'bias' decisions in the same manner as outcome narratives. Further, their potential to focus patient attention on key information and increase patient confidence in decision making appears significant.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/926/CN-01121926/frame.html

Record #14 of 90
ID: CN-00327335
AU: Goel V
AU: Sawka CA
AU: Thiel EC
AU: Gort EH
AU: O'Connor AM
TI: Randomized trial of a patient decision aid for choice of surgical treatment for breast cancer
SO: Medical decision making
YR: 2001
VL: 21
NO: 1
PG: 1-6
PM: PUBMED 11206942
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [surgery];Decision Support Techniques;Mastectomy;Patient Education as Topic;Patient Participation;Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-CANCER: SR-COMMUN
DOI: 10.1177/0272989X0102100101
AB: A decision aid for the surgical treatment of early breast cancer was evaluated in a randomized controlled trial. The decision aid, a tape and workbook, includes explicit presentation of probabilities, photographs and graphics, and a values clarification exercise. Community surgeons were randomized to use the decision aid or a control pamphlet. Patients completed a questionnaire prior to using the decision aid, after reviewing it but prior to surgery, and 6 months after enrollment. There was no difference in anxiety, knowledge, or decisional regret across the 2 groups. There was a nonsignificant trend toward lower decisional conflict in the decision aid group. A subgroup of women who were initially leaning toward mastectomy or were unsure had lower decisional conflict. Although the decision aid had minimal impact on the main study outcomes, a subgroup may have benefited. Such subgroups should be identified, and appropriate decision support interventions should be developed and evaluated.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/335/CN-00327335/frame.html

Record #15 of 90
ID: CN-01264028
AU: Luan A
AU: Hui KJ
AU: Remington AC
AU: Liu X
AU: Lee GK
TI: Effects of A Novel Decision Aid for Breast Reconstruction: a Randomized Prospective Trial
SO: Annals of plastic surgery
YR: 2016
VL: 76 Suppl 3
PG: S249-54
PM: PUBMED 27070681
PT: Journal Article; Randomized Controlled Trial
KY: Decision Support Techniques;Follow-Up Studies;Mammaplasty [methods] [psychology];Mastectomy [psychology];Outcome and Process Assessment (Health Care);Patient Participation [methods] [psychology];Patient Satisfaction [statistics & numerical data];Patient-Centered Care [methods];Prospective Studies;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1097/SAP.0000000000000722
AB: METHODS: We developed a novel decision aid to provide decision support and structured guidance for prosthetic, autologous, and combined prosthetic-autologous breast reconstruction surgery. New breast reconstruction patients of one surgeon at our institution were randomized by week to either receive the decision aid or standard preconsultation material. Immediately preceding their new patient consultation clinic visit, patients were asked to complete the validated Decisional Conflict Scale and the BREAST-Q Preoperative survey. After 3 to 5 months following breast mound reconstruction, patients were asked to complete the Decision Regret Scale, BREAST-Q Postoperative survey, and the Hospital Anxiety and Depression Scale.RESULTS: Patients who received the decision aid demonstrated a trend toward decreased preoperative decisional conflict (mean of 13.3 ± 5.5, compared to 26.2 ± 4.2; n = 8 per group, P = 0.069), with similar preoperative BREAST-Q scores. Most patients desired to know "everything" regarding their reconstruction surgery (75%), and to be "very involved" in the decisions in their care (81%), with remaining patients wanting to know "as much as I need to be prepared" and to be "somewhat involved." Postoperatively, patients who received the decision aid demonstrated significantly less decision regret (P < 0.001), although there was no significant difference in anxiety, depression, or quality of life-related outcomes as measured by the BREAST-Q.CONCLUSIONS: The use of decision aids in breast reconstruction surgery may help decrease decisional conflict and regret through promoting improved information sharing and shared decision making, which are highly important in this particular setting, patient population, and in our move toward greater patient-centered care.INTRODUCTION: The choice to undergo mastectomy and breast reconstruction is a highly personal decision with profound psychosocial effects, and ultimately, the decision between implant- and autologous tissue-based reconstruction should be made based on a combination of factual information and the patient's personal values and preferences. Unfortunately, patients undergoing breast reconstruction surgery may experience decision regret. Decision aids promote patient involvement in decision making by not only providing standard information about options, but also emphasizing comparative risks, benefits, and alternatives, and most importantly by providing clarification exercises regarding personal values to guide patients toward an individualized decision.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/028/CN-01264028/frame.html

Record #16 of 90
ID: CN-00327914
AU: Molenaar S
AU: Sprangers MA
AU: Rutgers EJ
AU: Luiten EJ
AU: Mulder J
AU: Bossuyt PM
AU: Everdingen JJ
AU: Oosterveld P
AU: Haes HC
TI: Decision support for patients with early-stage breast cancer: effects of an interactive breast cancer CDROM on treatment decision, satisfaction, and quality of life
SO: Journal of clinical oncology
YR: 2001
VL: 19
NO: 6
PG: 1676-1687
PM: PUBMED 11250997
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Body Image;Breast Neoplasms [psychology] [therapy];CD-ROM;Decision Making;Decision Making, Computer-Assisted;Longitudinal Studies;Mastectomy;Mastectomy, Segmental;Patient Satisfaction;Quality of Life;Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-COMMUN: SR-SYMPT
DOI: 10.1200/JCO.2001.19.6.1676
AB: PATIENTS AND METHODS: Consecutive patients with stage I and II breast cancer were enrolled. A quasi-experimental, longitudinal, and pretest/posttest design was used. Follow-up was scheduled 3 and 9 months after discharge from the hospital. Control patients (n = 88) received standard care (oral information and brochures). The CDROM was provided to patients in the experimental condition (n = 92) as a supplement to standard procedures. Outcome variables were treatment decision, satisfaction, and quality of life (QoL).RESULTS: No effect on treatment decision was found. CDROM patients expressed more general satisfaction with information at 3 and 9 months (95% confidence interval for the difference (d) between the means (d: 4.1 to 12.5 and 5.7 to 14.2 respectively). CDROM patients were also more satisfied with their treatment decision at 3 and at 9 months (d: 0.1 to 0.4; 0.2 to 0.5). Moreover, at 9 months, CDROM patients were more satisfied with breast cancer-specific information (d: 0.9 to 16.5), the decision-making process (d: 0.1 to 0.4), and communication (d: 0.2 to 11.0). At 3 and 9 months, a positive effect was found on general health (d: 0.2 to 14.5 and 0.3 to 15.0). Moreover, at 9 months, CDROM patients reported better physical functioning (d: 5.1 to 19.8), less pain (d: -17.9 to -4.5), and fewer arm symptoms (d: -14.1 to -0.5).CONCLUSION: The Interactive Breast Cancer CDROM improved decision making in patients with early-stage breast cancer with a choice between BCT and MT, as evaluated in terms of patients' satisfaction and QoL.PURPOSE: To investigate the effects of the Interactive Breast Cancer CDROM as a decision aid for breast cancer patients with a choice between breast conserving therapy (BCT) and mastectomy (MT).
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/914/CN-00327914/frame.html

Record #17 of 90
ID: CN-01124192
AU: Shaffer VA
AU: Tomek S
AU: Hulsey L
TI: The effect of narrative information in a publicly available patient decision aid for early-stage breast cancer.
SO: Health communication
YR: 2014
VL: 29
NO: 1
PG: 64-73
PM: PUBMED 23384155
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [pathology] [psychology] [surgery];Decision Support Techniques;Midwestern United States;Narration;Patient Preference;Video Recording;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];Young Adult[checkword]
DOI: 10.1080/10410236.2012.717341
AB: This study was designed to (1) evaluate the effect of narratives used in a popular, publicly available patient decision aid for early-stage breast cancer on hypothetical treatment decisions and attitudes toward the decision aid and (2) explore the moderating effects of participant numeracy, electronic health literacy and decision-making style. Two hundred women were asked to imagine that they had been diagnosed with early-stage breast cancer and viewed one of two versions of a video decision aid for early-stage breast cancer. The narrative version of the aid included stories from breast cancer survivors; the control version had no patient stories. After viewing the video decision aid, participants made a hypothetical treatment choice between lumpectomy with radiation and mastectomy, answered several questions about their decision, and evaluated the quality of the decision aid. Participants received $100 for completing the study. The two conditions differed in their motivations for the treatment decision and perceptions of the aid's trustworthiness and emotionality but showed no differences in preferences for surgical treatments or evaluations of the decision aid's quality. However, the impact of patient narratives was moderated by numeracy and electronic health literacy. Higher levels of numeracy were associated with decreased decisional confidence and lower ratings of trustworthiness for the decision aid in the narrative video condition but not in the control video condition. In contrast, higher levels of electronic health literacy were associated with increased decisional confidence and greater perceptions of trustworthiness and credibility of the decision aid in the narrative video condition but not the control video condition.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/192/CN-01124192/frame.html

Record #18 of 90
ID: CN-00684122
AU: Stalmeier PF
AU: Roosmalen MS
TI: Concise evaluation of decision aids
SO: Patient education and counseling
YR: 2009
VL: 74
NO: 1
PG: 104-109
PM: PUBMED 18775622
PT: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [genetics] [prevention & control];Choice Behavior;Decision Support Techniques;Factor Analysis, Statistical;Follow-Up Studies;Life Expectancy;Netherlands;Pamphlets;Patient Acceptance of Health Care [psychology] [statistics & numerical data];Patient Education as Topic [methods] [standards];Patient Satisfaction [statistics & numerical data];Prognosis;Quality-Adjusted Life Years;Risk Assessment;Risk Factors;Surveys and Questionnaires [standards];Videotape Recording [standards];Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-GYNAECA
DOI: 10.1016/j.pec.2008.07.043
AB: METHODSTwo different decision aids were randomized in patients at high risk for breast and ovarian cancer. Treatment choices were between prophylactic surgery and screening. Effect sizes were calculated to compare the responsiveness of the measures.RESULTSOne decision aid was randomized in 390 women, the other in 91 ensuing mutation carriers. Three factors were identified related to Information, Well-being and Decision Making. Within each factor, single item measures were as responsive as multi-item measures.CONCLUSIONFour single items, 'the amount of information received for decision making,' 'strength of preference,' 'I weighed the pros and cons,' and 'General Health,' were adequately responsive to the decision aids.PRACTICE IMPLICATIONSThese items might be considered for inclusion in questionnaires to evaluate decision aids.OBJECTIVEDecision aids purport to help patients make treatment related choices. Several instruments exist to evaluate decision aids. Our aim is to compare the responsiveness of several instruments.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/122/CN-00684122/frame.html

Record #19 of 90
ID: CN-00587385
AU: Jibaja-Weiss ML
AU: Volk RJ
AU: Granch TS
AU: Nefe NE
AU: Spann SJ
AU: Aoki N
AU: Robinson EK
AU: Freidman LC
AU: Beck JR
TI: Entertainment education for informed breast cancer treatment decisions in low-literate women: development and initial evaluation of a patient decision aid
SO: Journal of cancer education
YR: 2006
VL: 21
NO: 3
PG: 133-139
PM: PUBMED 17371175
PT: Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, Non-P.H.S.
KY: Breast Neoplasms [pathology] [therapy];Continental Population Groups [education];Decision Making;Decision Making, Computer-Assisted;Decision Support Techniques;Educational Status;Ethnic Groups [education];Health Knowledge, Attitudes, Practice;Neoplasm Staging;Patient Education as Topic [methods];Patient Satisfaction;Program Development;Program Evaluation;Research Design;Surveys and Questionnaires;Texas;User-Computer Interface;Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1207/s15430154jce2103_8
AB: METHODWe randomly assigned 51 patients diagnosed with early stage breast cancer to use the decision aid.RESULTSPatients who viewed the CDSS improved their knowledge of breast cancer treatment; found the application easy to use and understand, informative, and enjoyable; and were less worried about treatment.CONCLUSIONThe system clearly reached its intended objectives to create a usable decision aid for low-literate, novice computer users.BACKGROUNDWe report on the development and initial evaluation of a novel computerized decision support system (CDSS) that utilizes concepts from entertainment education (edutainment) to assist low-literate, multiethnic women in making initial surgical treatment decisions.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/385/CN-00587385/frame.html

Record #20 of 90
ID: CN-00439988
AU: Goodwin JS
AU: Satish S
AU: Anderson ET
AU: Nattinger AB
AU: Freeman JL
TI: Effect of nurse case management on the treatment of older women with breast cancer
SO: Journal of the american geriatrics society
YR: 2003
VL: 51
NO: 9
PG: 1252-1259
PM: PUBMED 12919237
PT: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial
KY: Age Factors;Breast Neoplasms [nursing] [psychology] [surgery] [therapy];Case Management;Data Interpretation, Statistical;Geriatric Assessment;Health Services Accessibility;Nurse's Role;Patient Satisfaction;Physician's Role;Prospective Studies;Psychiatric Status Rating Scales;Social Support;Socioeconomic Factors;Time Factors;Treatment Outcome;Aged[checkword];Aged, 80 and over[checkword];Female[checkword];Humans[checkword];Male[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-COMMUN: SR-EPOC
AB: DESIGNRandomized prospective trial.SETTINGSixty surgeons practicing at 13 community and two public hospitals in southeast Texas.PARTICIPANTSThree hundred thirty-five women (166 control and 169 intervention) aged 65 and older newly diagnosed with breast cancer.INTERVENTIONWomen seeing surgeons randomized to the intervention group received the services of a nurse case manager for 12 months after the diagnosis of breast cancer.MEASUREMENTSThe primary outcome was the type and use of cancer-specific therapies received in the first 6 months after diagnosis. Secondary outcomes were patient satisfaction and arm function on the affected side 2 months after diagnosis.RESULTSMore women in the intervention group received breast-conserving surgery (28.6% vs 18.7%; P=.031) and radiation therapy (36.0% vs 19.0%; P=.003). Of women undergoing breast-conserving surgery, greater percentages in the case management group received adjuvant radiation (78.3% vs 44.8%; P=.001) and axillary dissection (71.4% vs 44.8%; P=.057). Women in the case management group were also more likely to receive more breast reconstruction surgery (9.3% vs 2.6%, P=.054), and women in the case management group with advanced cancer were more likely to receive chemotherapy (72.7% vs 30.0%, P=.057). Two months after surgery, higher percentages of women in the case manager group had normal arm function (93% vs 84%; P=.037) and were more likely to state that they had a real choice in their treatment (82.2% vs 69.9%, P=.020). Women with indicators of poor social support were more likely to benefit from nurse case management.CONCLUSIONNurse case management results in more appropriate management of older women with breast cancer.OBJECTIVESTo evaluate the effect of nurse case management on the treatment of older women with breast cancer.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/988/CN-00439988/frame.html

Record #21 of 90
ID: CN-01110724
AU: Lam WW
AU: Fielding R
AU: Butow P
AU: Cowling BJ
AU: Chan M
AU: Or A
AU: Kwong A
AU: Suen D
TI: Decision aids for breast cancer surgery: a randomised controlled trial.
SO: Hong Kong medical journal = Xianggang yi xue za zhi
YR: 2014
VL: 20 Suppl 7
PG: 24-7
PM: PUBMED 25647821
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [surgery];China;Decision Making;Decision Support Techniques;Follow-Up Studies;Mastectomy [methods] [psychology];Pamphlets;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/724/CN-01110724/frame.html

Record #22 of 90
ID: CN-00578749
AU: Ozanne EM
AU: Annis C
AU: Adduci K
AU: Showstack J
AU: Esserman L
TI: Pilot trial of a computerized decision aid for breast cancer prevention
SO: Breast journal
YR: 2007
VL: 13
NO: 2
PG: 147-154
PM: PUBMED 17319855
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [prevention & control];Decision Making, Computer-Assisted;Feasibility Studies;Health Knowledge, Attitudes, Practice;Patient Education as Topic [methods];Patient Participation;Patient Satisfaction;Pilot Projects;Risk Assessment;San Francisco;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-COMMUN: SR-EPOC: SR-HEALTHP
DOI: 10.1111/j.1524-4741.2007.00395.x
AB: This study sought to evaluate a shared decision-making aid for breast cancer prevention care designed to help women make appropriate prevention decisions by presenting information about risk in context. The decision aid was implemented in a high-risk breast cancer prevention program and pilot-tested in a randomized clinical trial comparing standard consultations to use of the decision aid. Physicians completed training with the decision aid prior to enrollment. Thirty participants enrolled (15 per group) and completed measures of clinical feasibility and effectiveness prior to, immediately after, and at 9 months after their consultations. The decision aid was feasible to use during the consultations as measured by consultation duration, user satisfaction, patient knowledge, and decisional conflict. The mean consultation duration was not significantly different between groups (24 minutes for intervention group versus 21 minutes for control group, p = 0.42). The majority found the decision aid acceptable and useful and would recommend it to others. Both groups showed an improvement in breast cancer prevention knowledge postvisit, which was significant in the intervention group (p = 0.01) but not the control group (p = 0.13). However, the knowledge scores returned to baseline at follow-up in both groups. Decision preference for patients who chose chemoprevention post consultations remained constant at follow-up for the intervention group, but not for the control group. The decision framework provides access to key information during consultations and facilitates the integration of emerging biomarkers in this setting. Initial results suggest that the decision aid is feasible for use in the consultation room. The tendency for the decision choices and knowledge scores to return to baseline at follow-up suggests the need for initial and ongoing prevention decision support.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/749/CN-00578749/frame.html

Record #23 of 90
ID: CN-00119195
AU: Chapman GB
AU: Elstein AS
AU: Hughes KK
TI: Effects of patient education on decisions about breast cancer treatments: a preliminary report
SO: Medical decision making
YR: 1995
VL: 15
NO: 3
PG: 231-239
PM: PUBMED 7564937
PT: Clinical Trial; Comparative Study; Controlled Clinical Trial; Journal Article; Research Support, U.S. Gov't, P.H.S.
KY: Adolescent;Breast Neoplasms [psychology] [therapy];Decision Making;Educational Measurement;Mammaplasty;Mastectomy;Pamphlets;Patient Education as Topic [methods];Patient Participation;Prostheses and Implants;Teaching Materials;Videotape Recording;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-CANCER
DOI: 10.1177/0272989X9501500306
AB: The authors examined the effects of materials for educating patients about treatment options for breast cancer on knowledge about the disease, preferences for alternative treatments, and how changes in knowledge and preferences were related. Eighty-two undergraduate students acted as advisors to a hypothetical patient. They completed a knowledge test and rated their preferences for three options--breast-sparing surgery with radiation, mastectomy followed by reconstructive surgery, and mastectomy followed by use of a breast prosthesis--before and after viewing a videotape or a booklet version of the educational materials. Both formats increased knowledge scores. Treatment preferences were not affected by reading the booklet, but viewing the videotape resulted in a preference shift toward breast-sparing surgery. This media difference may be due to features of the video that were not reproduced in the booklet, such as interviews with other patients. Knowledge gains were uncorrelated with preference changes.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/195/CN-00119195/frame.html

Record #24 of 90
ID: CN-01026625
AU: Sherman KA
AU: Harcourt D
AU: Lam T
AU: Boyages J
TI: Breconda: Development and acceptability of an interactive decisional support tool for women considering breast reconstruction.
SO: Cancer research
YR: 2012
VL: 72
NO: 24 SUPPL. 3
XR: EMBASE 71097351
PT: Journal: Conference Abstract
KY: *human; *breast reconstruction; *breast cancer; *female; follow up; decision making; satisfaction; surgery; patient; risk; mastectomy; personal value; teleconsultation; breast surgery; diagnosis; relaxation training; stress management; breast; mental stress; decision support system; surgeon; interview; videorecording; cancer prevention
DOI: 10.1158/0008-5472.SABCS12-P4-17-04
AB: Introduction: Women needing a mastectomy for breast cancer, or cancer prophylaxis, are faced with the difficult decision regarding whether, and how, to restore breast shape after surgery. To a large extent this decision is based on personal preferences and values. In view of limited support resources available in this context, we have developed an online interactive decision aid, BRECONDA, to assist with decision-making. BRECONDA uses a multi-media platform to provide up-to-date information about surgical choices, interactive decision sheets encouraging women to weigh-up perceived benefits and risks and identify personal values and preferences, and video recorded patient stories. Since psychological stress can hamper decision-making, BRECONDA also demonstrates videoed stress management relaxation techniques. The aim of this study was to assess the user acceptability of this intervention. Methods: Following diagnosis, and prior to surgery, 54 women with breast cancer who were eligible for breast reconstruction following mastectomy were randomly assigned into one of two conditions: 1) Intervention group which received access to the BRECONDA program as well as a standard information booklet about breast surgery given to all such patients; and, 2) Control/Usual care group which received the standard information booklet alone. User ratings of satisfaction and reactions to BRECONDA were documented at 6-week follow-up for the Intervention group through quantitative measures and telephone interviews. Additionally, perceived decisional conflict, distress (intrusive and avoidant thoughts), knowledge and satisfaction with information at the 6-week assessment were documented for all participants. ANCOVAs were used to identify between group differences on these key variables at follow-up. Results: Intervention participants' ratings of BRECONDA demonstrated high user acceptability, with high scores on perceived usefulness, ease of use and provision of sufficient information. Interview data indicated that Intervention participants perceived BRECONDA to be well-balanced, informative, and beneficial to the decision making process and that it helped them feel more secure in their decision and to prepare questions for their surgeon. Interactive decision sheets, patient testimonials and photo galleries were highly valued by all interviewees. At follow-up, 40% of participants had undergone immediate reconstruction, with fewer Intervention participants electing this surgery. Furthermore, Intervention participants reported lower decisional conflict compared with Usual Care participants at follow-up (p <.05). Specifically, these participants reported feeling significantly clearer about personal values for benefits and risks of reconstruction compared with those receiving Usual Care. Conclusions: Users of the interactive online BRECONDA intervention reported high levels of user satisfaction with this innovative decisional support resource, as well as benefits in terms of experiencing less decisional conflict related to the ability to clarify the values that are personally important in the decision making context. This provides preliminary evidence for the acceptability and efficacy of this decision support intervention.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/625/CN-01026625/frame.html

Record #25 of 90
ID: CN-00528490
AU: Peele PB
AU: Siminoff LA
AU: Xu Y
AU: Ravdin PM
TI: Decreased use of adjuvant breast cancer therapy in a randomized controlled trial of a decision aid with individualized risk information
SO: Medical decision making
YR: 2005
VL: 25
NO: 3
PG: 301-307
PM: PUBMED 15951457
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
KY: Algorithms;Antineoplastic Agents [therapeutic use];Breast Neoplasms [classification] [drug therapy] [surgery];Chemotherapy, Adjuvant [utilization];Decision Support Techniques;Models, Statistical;Ohio;Patient Acceptance of Health Care [statistics & numerical data];Patient Education as Topic;Physicians [classification] [statistics & numerical data];Risk Assessment;Severity of Illness Index;Socioeconomic Factors;Texas;Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-COMMUN
DOI: 10.1177/0272989X05276851
AB: METHOD386 women with breast cancer were randomized to receive either an informational pamphlet about adjuvant therapy (usual care) or a patient-specific, evidence-based decision aid about adjuvant therapy. The authors compared rates of adjuvant therapy between the groups controlling for age, education, marital status, race, tumor severity, and practice type of their physician (university-based or community-based).RESULTSAmong women with low tumor severity, only 58% (35/60) of women in the decision aid group chose adjuvant therapy, compared to 87% (33/38) of their counterparts in usual care (P<0.01).CONCLUSIONSThis study illustrates the important impact of medical decision aids on treatment choices, particularly for patients for whom treatment has little benefit. In the case of adjuvant therapy for breast cancer, providing individualized, evidence-based risk information for shared decision making resulted in fewer women with low tumor severity choosing adjuvant treatment.OBJECTIVEOncology patients often seek involvement in their medical consultations. Such involvement is endorsed by most health care providers and mirrored in practice guidelines. However, oncologists exhibit great variation in how they provide patients with disease-relevant information, and many remain reluctant to do so at all. The authors examined the impact of a patient-specific decision aid on women's decisions about adjuvant therapy for breast cancer.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/490/CN-00528490/frame.html

Record #26 of 90
ID: CN-01285363
AU: Manne SL
AU: Topham N
AU: D'Agostino TA
AU: Myers Virtue S
AU: Kirstein L
AU: Brill K
AU: Manning C
AU: Grana G
AU: Schwartz MD
AU: Ohman-Strickland P
TI: Acceptability and pilot efficacy trial of a web-based breast reconstruction decision support aid for women considering mastectomy
SO: Psycho-oncology
YR: 2016
VL: 25
NO: 12
PG: 1424-1433
XR: EMBASE 606090874
PT: Journal: Article
KY: adult; aged; anxiety; article; *breast cancer/su [Surgery]; *breast reconstruction; cancer diagnosis; cancer patient; clinical decision making; *clinical decision support system; *clinical effectiveness; community program; conflict; controlled study; female; follow up; health survey; human; *Internet; knowledge; major clinical study; *mastectomy; medical literature; pilot study; *program acceptability; randomized controlled trial; treatment duration; *web based breast reconstruction decision support aid; breast cancer; community; *decision support system; *female; *human; neoplasm; randomization; satisfaction; speech
DOI: 10.1002/pon.3984
AB: Objective: The study aim was to test the acceptability and preliminary efficacy of a novel interactive web-based breast reconstruction decision support aid (BRAID) for newly diagnosed breast cancer patients considering mastectomy. Methods: Fifty-five women considering mastectomy were randomly assigned to receive the BRAID versus the Cancer Support Community's Frankly Speaking About Cancer: Breast Reconstruction pamphlet. Participants completed measures of breast reconstruction (BR) knowledge, preparation to make a decision, decisional conflict, anxiety, and BR intentions before randomization and 2 weeks later. Results: In terms of acceptability, enrollment into the study was satisfactory, but the rate of return for follow-up surveys was lower among BRAID participants than pamphlet participants. Both interventions were evaluated favorably in terms of their value in facilitating the BR decision, and the majority of participants completing the follow-up reported viewing the materials. In terms of preliminary efficacy, both interventions resulted in significant increases in BR knowledge and completeness and satisfaction with preparation to make a BR decision, and both interventions resulted in a significant reduction in decision conflict. However, there were no differences between interventions. Conclusion: A widely available free pamphlet and a web-based customized decision aid were highly utilized. The pamphlet was as effective in educating women about BR and prepared women equally as well to make the BR decision as compared with a more costly, customized web-based decision support aid. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/363/CN-01285363/frame.html

Record #27 of 90
ID: CN-00687070
AU: Schwartz MD
AU: Valdimarsdottir HB
AU: DeMarco TA
AU: Peshkin BN
AU: Lawrence W
AU: Rispoli J
AU: Brown K
AU: Isaacs C
AU: O'Neill S
AU: Shelby R
AU: Grumet SC
AU: McGovern MM
AU: Garnett S
AU: Bremer H
AU: Leaman S
AU: O'Mara K
AU: Kelleher S
AU: Komaridis K
TI: Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction
SO: Health psychology
YR: 2009
VL: 28
NO: 1
PG: 11-19
PM: PUBMED 19210013
PT: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
KY: Breast Neoplasms [genetics];Decision Making;Genes, BRCA1;Genes, BRCA2;Genetic Counseling;Genetic Testing [psychology];Mastectomy;Patient Satisfaction;Risk Assessment;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1037/a0013147
AB: DESIGN: After the completion of genetic counseling, 214 female (aged 21-75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N = 114) or Usual Care plus Decision Aid (DA; N = 100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM DA to view at home.MAIN OUTCOME MEASURES: The authors measured final management decision, decisional conflict, decisional satisfaction, and receipt of risk reducing mastectomy at 1-, 6-, and 12-months postrandomization.RESULTS: Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR = 3.09, 95% CI = 1.62, 5.90; p < .001), decreased decisional conflict (B = -.46, z = -3.1, p <002), and increased satisfaction (B = .27, z = 3.1, p = .002) compared to UC. Among carriers who had already made a management decision by the time of randomization, the DA had no benefit relative to UC.CONCLUSION: These results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support.OBJECTIVE: Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, the authors developed a computer-based interactive decision aid that was tested against usual care in a randomized controlled trial.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/070/CN-00687070/frame.html

Record #28 of 90
ID: CN-01037900
AU: Juraskova I
AU: Butow P
AU: Bonner C
AU: Bell ML
AU: Smith AB
AU: Seccombe M
AU: Boyle F
AU: Reaby L
AU: Cuzick J
AU: Forbes JF
TI: Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.
SO: British journal of cancer
YR: 2014
VL: 111
NO: 1
PG: 1-7
PM: PUBMED 24892447
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [prevention & control];Decision Making;Decision Support Techniques;Patient Participation [psychology];Patient Satisfaction;Randomized Controlled Trials as Topic [methods] [psychology];Surveys and Questionnaires;Treatment Outcome;Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1038/bjc.2014.144
AB: BACKGROUND: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial.METHODS: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up).RESULTS: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up.CONCLUSIONS: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/900/CN-01037900/frame.html

Record #29 of 90
ID: CN-01267948
AU: Manne SL
AU: Topham N
AU: D'Agostino TA
AU: Myers Virtue S
AU: Kirstein L
AU: Brill K
AU: Manning C
AU: Grana G
AU: Schwartz MD
AU: Ohman-Strickland P
TI: Acceptability and pilot efficacy trial of a web-based breast reconstruction decision support aid for women considering mastectomy
SO: Psycho-oncology
YR: 2016
VL: 25
NO: 12
PG: 1424-1433
XR: EMBASE 606090874
PT: Journal: Article
KY: anxiety; breast cancer; *breast reconstruction; cancer patient; community; *decision support system; *female; follow up; *human; *mastectomy; neoplasm; randomization; satisfaction; speech
DOI: 10.1002/pon.3984
AB: Objective: The study aim was to test the acceptability and preliminary efficacy of a novel interactive web-based breast reconstruction decision support aid (BRAID) for newly diagnosed breast cancer patients considering mastectomy. Methods: Fifty-five women considering mastectomy were randomly assigned to receive the BRAID versus the Cancer Support Community's Frankly Speaking About Cancer: Breast Reconstruction pamphlet. Participants completed measures of breast reconstruction (BR) knowledge, preparation to make a decision, decisional conflict, anxiety, and BR intentions before randomization and 2 weeks later. Results: In terms of acceptability, enrollment into the study was satisfactory, but the rate of return for follow-up surveys was lower among BRAID participants than pamphlet participants. Both interventions were evaluated favorably in terms of their value in facilitating the BR decision, and the majority of participants completing the follow-up reported viewing the materials. In terms of preliminary efficacy, both interventions resulted in significant increases in BR knowledge and completeness and satisfaction with preparation to make a BR decision, and both interventions resulted in a significant reduction in decision conflict. However, there were no differences between interventions. Conclusion: A widely available free pamphlet and a web-based customized decision aid were highly utilized. The pamphlet was as effective in educating women about BR and prepared women equally as well to make the BR decision as compared with a more costly, customized web-based decision support aid. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/948/CN-01267948/frame.html

Record #30 of 90
ID: CN-00907240
AU: Banegas MP
AU: McClure JB
AU: Barlow WE
AU: Ubel PA
AU: Smith DM
AU: Zikmund-Fisher BJ
AU: Greene SM
AU: Fagerlin A
TI: Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer.
SO: Patient education and counseling
YR: 2013
VL: 91
NO: 3
PG: 364-71
PM: PUBMED 23395006
XR: EMBASE 2013285495
PT: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
KY: Breast Neoplasms [drug therapy] [prevention & control] [psychology];Conflict (Psychology);Decision Support Techniques;Internet;Michigan;Raloxifene Hydrochloride [therapeutic use];Risk Factors;Tamoxifen [therapeutic use];Treatment Outcome;Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];adult; aged; article; *breast cancer/dt [Drug Therapy]; *breast cancer/pc [Prevention]; cancer risk; conflict; controlled study; *decision support system; drug use; female; follow up; high risk patient; human; individualization; Internet; major clinical study; patient decision making; priority journal; prophylaxis; randomized controlled trial; raloxifene/dt [Drug Therapy]; tamoxifen/dt [Drug Therapy]
DOI: 10.1016/j.pec.2012.12.014
AB: OBJECTIVE: To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women's decisions about prophylactic tamoxifen and raloxifene use.METHODS: Postmenopausal women, age 46-74, with BCRAT 5-year risk ≥ 1.66% and no prior history of breast cancer were randomized to one of three study arms:intervention (n=690), Time 1 control (n=160), or 3-month control (n=162). Intervention participants viewed GtD prior to completing a post-test and 3 month follow-up assessment. Controls did not. We assessed the impact of GtD on women's decisional conflict levels and treatment decision behavior at post-test and at 3 months, respectively.RESULTS: Intervention participants had significantly lower decisional conflict levels at post-test (p<0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p<0.001) compared to control participants.CONCLUSION: GtD lowered decisional conflict and helped women at high risk of breast cancer decide whether to take prophylactic tamoxifen or raloxifene to reduce their cancer risk.PRACTICE IMPLICATIONS: Web-based, tailored decision aids should be used more routinely to facilitate informed medical decisions, reduce patients' decisional conflict, and empower patients to choose the treatment strategy that best reflects their own values.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/240/CN-00907240/frame.html

Record #31 of 90
ID: CN-01121666
AU: Korfage IJ
AU: Fuhrel-Forbis A
AU: Ubel PA
AU: Zikmund-Fisher BJ
AU: Greene SM
AU: McClure JB
AU: Smith DM
AU: Alford SH
AU: Fagerlin A
TI: Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention.
SO: Breast cancer research : BCR
YR: 2013
VL: 15
NO: 5
PG: R74
PM: PUBMED 24004815
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
KY: Breast Neoplasms [prevention & control];Chemoprevention;Decision Making;Decision Support Techniques;Follow-Up Studies;Health Knowledge, Attitudes, Practice;Informed Consent;Internet;Premedication;Raloxifene Hydrochloride [administration & dosage];Risk Factors;Selective Estrogen Receptor Modulators [administration & dosage];Tamoxifen [administration & dosage];Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1186/bcr3468
AB: INTRODUCTION: Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.METHODS: We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women’s intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable ‘informed choice’ (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman’s decision and relevant attitudes.RESULTS: Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.CONCLUSIONS: The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.TRIAL REGISTRATION: ClinicalTrials.gov: NCT00967824
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/666/CN-01121666/frame.html

Record #32 of 90
ID: CN-00887710
AU: Harwood R
AU: Douglas C
AU: Clark D
TI: Decision aids for breast and nodal surgery in patients with early breast cancer: Development and a pilot study.
SO: Asia-Pacific journal of clinical oncology
YR: 2011
VL: 7
NO: 2
PG: 114-22
XR: EMBASE 2011277484
PT: Journal: Article
KY: adult // article // axillary lymph node // *breast cancer/su [Surgery] // *breast surgery // clinical article // clinical decision making // comparative study // controlled study // *early cancer/su [Surgery] // female // human // intermethod comparison // *lymph node dissection // mastectomy // partial mastectomy // patient satisfaction // pilot study // priority journal // randomized controlled trial // sentinel lymph node biopsy
DOI: 10.1111/j.1743-7563.2010.01375.x
AB: Aim: As survival rates for aggressive and conservative breast and lymph node surgery are similar, surgical treatment decisions for patients with early-stage breast cancer should take patient preference into account. Decision aids have been demonstrated to increase patient knowledge and satisfaction with decision making, while decreasing decisional conflict. Hundreds of decision aids exist; however, few address lymph node surgery in any detail, and none acknowledge that there is a choice comparable to that between mastectomy and breast-conserving therapy. Methods: A systematic process was employed to develop decision aids for mastectomy versus breast-conserving therapy, axillary dissection versus sentinel node biopsy, and options following a positive sentinel node biopsy. The first two of these decision aids were evaluated in a small pilot study. Choice of operation, knowledge and decisional conflict and satisfaction were compared with outcomes in an historical control group. Results: Women reported favorably on the decision aids. The numbers in the pilot group were too small to allow definitive conclusions to be drawn, but suggested a possible reduction in decisional conflict, and possibly increase in decisional satisfaction, knowledge and choice of axillary clearance (rather than sentinel node biopsy) in the intervention group. Conclusion: These decision aids could improve decision making for the surgical treatment of early breast cancer. A prospective randomized, control trial is needed to further evaluate the impact of these decision aids, particularly in the case of nodal surgery. 2011 Blackwell Publishing Asia Pty Ltd.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/710/CN-00887710/frame.html

Record #33 of 90
ID: CN-01082842
AU: Hersch J
AU: Barratt A
AU: Jansen J
AU: Irwig L
AU: McGeechan K
AU: Jacklyn G
AU: Thornton H
AU: Dhillon H
AU: Houssami N
AU: McCaffery K
TI: Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial.
SO: Lancet (London, England)
YR: 2015
VL: 385
NO: 9978
PG: 1642-52
PM: PUBMED 25701273
XR: EMBASE 2015763529
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [prevention & control] [radiography];Decision Making;Decision Support Techniques;Health Knowledge, Attitudes, Practice;Mammography [utilization];Patient Education as Topic;Patient Participation;Female[checkword];Humans[checkword];Middle Aged[checkword];adult; article; Australia; *breast cancer/di [Diagnosis]; cancer mortality; *cancer screening; *clinical decision making; computer program; controlled study; false positive result; female; follow up; human; major clinical study; mammography; *medical information; middle aged; outcome assessment; priority journal; randomized controlled trial; telephone interview
DOI: 10.1016/S0140-6736(15)60123-4
AB: BACKGROUND: Mammography screening can reduce breast cancer mortality. However, most women are unaware that inconsequential disease can also be detected by screening, leading to overdiagnosis and overtreatment. We aimed to investigate whether including information about overdetection of breast cancer in a decision aid would help women aged around 50 years to make an informed choice about breast screening.METHODS: We did a community-based, parallel-group, randomised controlled trial in New South Wales, Australia, using a random cohort of women aged 48-50 years. Recruitment to the study was done by telephone; women were eligible if they had not had mammography in the past 2 years and did not have a personal or strong family history of breast cancer. With a computer program, we randomly assigned 879 participants to either the intervention decision aid (comprising evidence-based explanatory and quantitative information on overdetection, breast cancer mortality reduction, and false positives) or a control decision aid (including information on breast cancer mortality reduction and false positives). Participants and interviewers were masked to group assignment. The primary outcome was informed choice (defined as adequate knowledge and consistency between attitudes and screening intentions), which we assessed by telephone interview about 3 weeks after random allocation. The primary outcome was analysed in all women who completed the relevant follow-up interview questions fully. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001035718.FINDINGS: Between January, 2014, and July, 2014, 440 women were allocated to the intervention group and 439 were assigned to the control group. 21 women in the intervention group and 20 controls were lost to follow-up; a further ten women assigned to the intervention and 11 controls did not answer all questions on attitudes. Therefore, 409 women in the intervention group and 408 controls were analysed for the primary outcome. 99 (24%) of 409 women in the intervention group made an informed choice compared with 63 (15%) of 408 in the control group (difference 9%, 95% CI 3-14; p=0·0017). Compared with controls, more women in the intervention group met the threshold for adequate overall knowledge (122/419 [29%] vs 71/419 [17%]; difference 12%, 95% CI 6-18; p<0·0001), fewer women expressed positive attitudes towards screening (282/409 [69%] vs 340/408 [83%]; 14%, 9-20; p<0·0001), and fewer women intended to be screened (308/419 [74%] vs 363/419 [87%]; 13%, 8-19; p<0·0001). When conceptual knowledge alone was considered, 203 (50%) of 409 women in the intervention group made an informed choice compared with 79 (19%) of 408 in the control group (p<0·0001).INTERPRETATION: Information on overdetection of breast cancer provided within a decision aid increased the number of women making an informed choice about breast screening. Becoming better informed might mean women are less likely to choose screening.FUNDING: Australian National Health and Medical Research Council.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/842/CN-01082842/frame.html

Record #34 of 90
ID: CN-00687075
AU: Vodermaier A
AU: Caspari C
AU: Koehm J
AU: Kahlert S
AU: Ditsch N
AU: Untch M
TI: Contextual factors in shared decision making: a randomised controlled trial in women with a strong suspicion of breast cancer
SO: British journal of cancer
YR: 2009
VL: 100
NO: 4
PG: 590-597
PM: PUBMED 19209172
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [diagnosis] [psychology] [therapy];Decision Making;Germany;Patient Participation;Patient Satisfaction;Referral and Consultation;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];Young Adult[checkword]
CC: SR-EPOC
DOI: 10.1038/sj.bjc.6604916
AB: Decision aids in North American breast cancer outpatients have been shown to assist with treatment decision making and reduce decisional conflict. To date, appropriate delivery formats to effectively increase patient participation in newly diagnosed breast cancer inpatients have not been investigated in the context of German health care provision. The impact of a decision aid intervention was studied in patients (n=111) with a strong suspicion of breast cancer in a randomised controlled trial. The primary outcome variable was decisional conflict. Participants were followed up 1 week post-intervention with a retention rate of 92%. Analyses revealed that the intervention group felt better informed (eta(p)(2)=0.06) but did not experience an overall reduction in decisional conflict as compared with the control group. The intervention had no effect on uptake rates of treatment options, length of consultation with the surgeon, time point of treatment decision making, perceived involvement in decision making, neither decision related nor general patient satisfaction. Patients who received the decision aid intervention experienced a small benefit with regards to how informed they felt about advantages and disadvantages of relevant treatment options. Results are discussed in terms of contextual factors and individual differences as moderators of treatment decision aid effectiveness.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/075/CN-00687075/frame.html

Record #35 of 90
ID: CN-00761776
AU: Ubel PA
AU: Smith DM
AU: Zikmund-Fisher BJ
AU: Derry HA
AU: McClure J
AU: Stark A
AU: Wiese C
AU: Greene S
AU: Jankovic A
AU: Fagerlin A
TI: Testing whether decision aids introduce cognitive biases: results of a randomized trial
SO: Patient education and counseling
YR: 2010
VL: 80
NO: 2
PG: 158-163
PM: PUBMED 20004545
PT: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
KY: Breast Neoplasms [prevention & control];Cognition;Comprehension;Decision Making;Decision Support Techniques;Health Knowledge, Attitudes, Practice;Patient Education as Topic [methods];Risk Assessment;Selective Estrogen Receptor Modulators [therapeutic use];Tamoxifen [therapeutic use];Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1016/j.pec.2009.10.021
AB: METHODS: We recruited 663 women at high risk of breast cancer and presented them with a DA designed to experimentally test potential methods of identifying and reducing cognitive biases that could influence this decision, by varying specific aspects of the DA across participants in a factorial design.RESULTS: Participants were susceptible to a cognitive bias - an order effect - such that those who learned first about the risks of tamoxifen thought more favorably of the drug than women who learned first about the benefits. This order effect was eliminated among women who received additional information about competing health risks.CONCLUSION: We discovered that the order of risk/benefit information influenced women's perceptions of tamoxifen. This bias was eliminated by providing contextual information about competing health risks.PRACTICE IMPLICATIONS: We have demonstrated the feasibility of using factorial experimental designs to test whether DAs introduce cognitive biases, and whether specific elements of DAs can reduce such biases.OBJECTIVE: Women at high risk of breast cancer face a difficult decision whether to take medications like tamoxifen to prevent a first breast cancer diagnosis. Decision aids (DAs) offer a promising method of helping them make this decision. But concern lingers that DAs might introduce cognitive biases.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/776/CN-00761776/frame.html

Record #36 of 90
ID: CN-00520779
AU: Tiller K
AU: Meiser B
AU: Gould L
AU: Tucker K
AU: Dudding T
AU: Franklin J
AU: Friedlander M
AU: Andrews L
TI: Knowledge of risk management strategies, and information and risk management preferences of women at increased risk for ovarian cancer
SO: Psycho-oncology
YR: 2005
VL: 14
NO: 4
PG: 249-261
PM: PUBMED 15386771
PT: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [genetics] [prevention & control] [psychology];Choice Behavior;Colorectal Neoplasms, Hereditary Nonpolyposis [genetics] [prevention & control] [psychology];Contraceptives, Oral [administration & dosage];Decision Support Techniques;Genes, Dominant;Genetic Predisposition to Disease [genetics] [psychology];Health Knowledge, Attitudes, Practice;Heterozygote Detection;Mass Screening [psychology];Neoplasms, Glandular and Epithelial [genetics] [prevention & control] [psychology];Neoplastic Syndromes, Hereditary [genetics] [prevention & control] [psychology];New South Wales;Oncology Service, Hospital [utilization];Ovarian Neoplasms [genetics] [prevention & control] [psychology];Ovariectomy [psychology];Patient Acceptance of Health Care [psychology];Patient Education as Topic;Patient Participation [psychology];Risk Assessment;Risk Reduction Behavior;Victoria;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-GYNAECA
DOI: 10.1002/pon.840
AB: Little research is available on the level of knowledge about ovarian cancer risk management options in women at increased risk for this disease. The study objectives were to evaluate this together with the information and ovarian cancer risk management preferences of high-risk women. One hundred and twenty-nine women were assessed after their attendance at one of six familial cancer clinics in relation to knowledge of surveillance and/or preventative strategies for reduction of ovarian cancer risk, preferences for particular strategies, and information preferences. Screening was selected by 57 (44%) women as the preferred risk management option. One hundred and five women (82%) indicated a wish for as much information as possible about ovarian cancer, including both good and bad outcomes and 114 (89%) reported a preference for sharing treatment decisions with their health professional. Participants' knowledge about ovarian cancer risk management options was significantly associated with educational levels (Z = -3.2, p=0.001) and whether or not ovarian cancer was included in the family history (Z = -2.3, p = 0.018). Findings from this present study indicate that women at increased risk of ovarian cancer who attend familial cancer clinics want as much information as possible about this disease and they want to be involved in the decision-making process. Women who reported a lower level of education (no post-school qualifications) may be most likely to benefit from additional educational strategies designed to supplement genetic counseling to improve their knowledge levels.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/779/CN-00520779/frame.html

Record #37 of 90
ID: CN-00703783
AU: Mathieu E
AU: Barratt A
AU: Davey HM
AU: McGeechan K
AU: Howard K
AU: Houssami N
TI: Informed choice in mammography screening: a randomized trial of a decision aid for 70-year-old women
SO: Archives of internal medicine
YR: 2007
VL: 167
NO: 19
PG: 2039-2046
PM: PUBMED 17954796
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [diagnostic imaging];Choice Behavior;Decision Support Techniques;Health Knowledge, Attitudes, Practice;Mammography [statistics & numerical data] [utilization];New South Wales;Outcome Assessment (Health Care);Patient Education as Topic;Patient Participation;Patient Satisfaction;Aged[checkword];Female[checkword];Humans[checkword]
CC: SR-BREASTCA
DOI: 10.1001/archinte.167.19.2039
AB: METHODSTo assess the effect of a decision aid (DA) about whether to continue or stop mammography screening for women aged 70 years, a population-based, randomized controlled trial was conducted in New South Wales, Australia. Women aged 70 years who had regularly participated in mammography screening were eligible to participate in the trial. Women received a DA providing balanced, quantitative information or standard information available from the screening program. The main outcomes were the percentage of women making an informed choice about whether to continue or stop screening and the percentage of women participating in the screening.RESULTSWomen who received the DA (the intervention group) were better informed than the control group (mean increase in knowledge score out of 10, 2.62 for the intervention group vs 0.68 for the control group; P < .001), and a significantly greater percentage made an informed choice (73.5% vs 48.8%; P < .001). The DA did not increase anxiety and slightly reduced decisional conflict. There was no difference in the percentage of women who participated in screening within 1 month.CONCLUSIONSThis DA increased knowledge and assisted women to make an informed choice. It did not alter participation in screening. The DA is an effective way to assist women to make a decision about continuing mammography screening and seems to be a feasible intervention within a population screening program.BACKGROUNDMany women who have participated in mammography screening are now approaching 70 years of age. These women are advised to consider both the benefits and harms of continuing to be screened. Doing so may be difficult for individual women, and there are no evaluated decision support tools to assist them.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/783/CN-00703783/frame.html

Record #38 of 90
ID: CN-01165872
AU: Clemons M
AU: Bouganim N
AU: Smith S
AU: Mazzarello S
AU: Vandermeer L
AU: Segal R
AU: Dent S
AU: Gertler S
AU: Song X
AU: Wheatley-Price P
AU: Dranitsaris G
TI: Risk Model-Guided Antiemetic Prophylaxis vs Physician's Choice in Patients Receiving Chemotherapy for Early-Stage Breast Cancer: A Randomized Clinical Trial.
SO: JAMA oncology
YR: 2016
VL: 2
NO: 2
PG: 225-31
PM: PUBMED 26562292
XR: EMBASE 26562292
PT: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Anthracyclines [adverse effects];Antiemetics [administration & dosage] [adverse effects];Antineoplastic Combined Chemotherapy Protocols [adverse effects];Benzodiazepines [administration & dosage];Breast Neoplasms [drug therapy] [pathology];Choice Behavior;Cyclophosphamide [adverse effects];Decision Support Techniques;Dexamethasone [administration & dosage];Drug Administration Schedule;Nausea [chemically induced] [prevention & control];Neoplasm Staging;Ondansetron [administration & dosage];Ontario;Patient Selection;Practice Patterns, Physicians';Predictive Value of Tests;Risk Assessment;Risk Factors;Time Factors;Treatment Outcome;Vomiting [chemically induced] [prevention & control];Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];adult; aged; Breast Neoplasms/dt [Drug Therapy]; cancer staging; chemically induced; *clinical practice; clinical trial; comparative study; controlled study; decision making; *decision support system; drug administration; female; human; middle aged; multicenter study; nausea/pc [Prevention]; Ontario; pathology; patient selection; predictive value; randomized controlled trial; risk assessment; risk factor; time factor; treatment outcome; vomiting/pc [Prevention]; anthracycline/ae [Adverse Drug Reaction]; antiemetic agent/ad [Drug Administration]; antiemetic agent/ae [Adverse Drug Reaction]; antineoplastic agent/ae [Adverse Drug Reaction]; benzodiazepine derivative/ad [Drug Administration]; cyclophosphamide/ae [Adverse Drug Reaction]; dexamethasone/ad [Drug Administration]; olanzapine; ondansetron/ad [Drug Administration]
DOI: 10.1001/jamaoncol.2015.3730
AB: IMPORTANCE: Despite multiple patient-centered factors being associated with the risk of chemotherapy-induced nausea and vomiting (CINV), these factors are rarely considered when making antiemetic recommendations. OBJECTIVE: To compare risk model-guided (RMG) antiemetic prophylaxis with physician's choice (PC) in patients receiving chemotherapy for early-stage breast cancer. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 324 patients with early-stage breast cancer undergoing chemotherapy (cyclophosphamide and an anthracycline) for the first time at 2 specialty cancer care centers in Ottawa from April 10, 2012, to September 2, 2014. Patients were randomized to either the RMG arm (n = 154) or the PC control arm (n = 170). Prior to each cycle of chemotherapy patients in the RMG group were categorized as low or high risk for CINV, and their antiemetic treatments were adjusted accordingly. INTERVENTIONS: Patients considered to be at low risk received standard dexamethasone and a 5-HT3 antagonist, while those at high risk also received aprepitant with or without olanzapine, based on their risk level. The PC control group received antiemetic agents according to the treating physician's discretion. MAIN OUTCOMES AND MEASURES: The primary end points were control of both nausea and vomiting in the acute posttreatment period (first 24 hours after therapy) and in the delayed posttreatment period (days 2-5 after therapy). RESULTS: The total numbers of chemotherapy cycles delivered in the RMG and PC control groups were 497 and 551 respectively. In the acute period, significantly more patients in the RMG group reported no nausea (53.7% [95% CI, 49.2%-58.1%] vs 41.6% [95% CI, 37.4%-45.3%]; P <.001) and no vomiting (91.8% [95% CI, 89.0%-94.0%] vs 82.2% [95% CI, 78.8%-85.3%]; P <.001) compared with the PC control group. Similarly, significantly more patients in the RMG group reported no nausea (39.6% [95% CI, 35.3%-44.1%] vs 30.7% [95% CI, 26.8%-34.7%]; P =.01) and no vomiting (87.1% [95% CI, 83.8%-90.0%) vs 78.0% [95% CI, 74.3%-81.4%]; P <.001) in the delayed period respectively. CONCLUSIONS AND RELEVANCE: In this trial, the RMG antiemetic prophylaxis led to improved control of acute and delayed CINV compared with physician's choice of therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01913990.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/872/CN-01165872/frame.html

Record #39 of 90
ID: CN-00698694
AU: Fagerlin A
AU: Zikmund-Fisher BJ
AU: Ubel PA
TI: "If I'm better than average, then I'm ok?": comparative information influences beliefs about risk and benefits
SO: Patient education and counseling
YR: 2007
VL: 69
NO: 1-3
PG: 140-144
PM: PUBMED 17942271
PT: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
KY: Analysis of Variance;Attitude to Health;Breast Neoplasms [etiology] [prevention & control];Chi-Square Distribution;Communication;Decision Making;Decision Support Techniques;Drug Therapy [psychology];Drug-Related Side Effects and Adverse Reactions;Health Behavior;Health Education [methods];Health Knowledge, Attitudes, Practice;Health Services Needs and Demand;Risk Assessment [methods];Risk Reduction Behavior;Surveys and Questionnaires;Women [education] [psychology];Women's Health;Adult[checkword];Aged[checkword];Aged, 80 and over[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1016/j.pec.2007.08.008
AB: METHODSTwo hundred and forty-nine female visitors to a hospital cafeteria were randomized to one of two conditions which differed in whether their hypothetical breast cancer risks was lower or higher than the average women's. Participants read a scenario describing a breast cancer prevention pill and indicated their: (1) likelihood of taking the pill and (2) perception of whether the pill provides breast cancer risk reduction.RESULTSWomen told that their hypothetical risk of breast cancer was above average were more likely to endorse taking the pill (2.79 vs. 2.23, F=4.95, p=0.002) and more likely to believe that the pill provided a significant risk reduction in breast cancer (3.15 vs. 2.73, F=4.32, p=0.005), even though the risks were equivalent.CONCLUSIONSProviding people with comparative risk information changes their risk perceptions. People who have above average risk may feel compelled to take a treatment because they are at above average risk and therefore may not thoroughly consider the trade-offs in the risks and benefits of treatment.PRACTICE IMPLICATIONSPhysicians and decision aid developers must reconsider the practice of communicating "average risk" information to patients.OBJECTIVETo test whether providing comparative risk information changes risk perceptions.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/694/CN-00698694/frame.html

Record #40 of 90
ID: CN-01157931
AU: Msaouel P
AU: Kappos T
AU: Tasoulis A
AU: Apostolopoulos AP
AU: Lekkas I
AU: Tripodaki ES
AU: Keramaris NC
TI: Comparison of resident performance in interpreting mammography results using a probabilistic or a natural frequency presentation: a multi-institutional randomized experimental study.
SO: Education for health (Abingdon, England)
YR: 2015
VL: 28
NO: 1
PG: 29-34
PM: PUBMED 26261111
XR: EMBASE 26261111
PT: Journal Article; Multicenter Study; Randomized Controlled Trial
KY: Bayes Theorem;Breast Neoplasms [diagnosis];Clinical Competence [standards] [statistics & numerical data];Data Interpretation, Statistical;Decision Making;Greece;Internship and Residency [standards] [statistics & numerical data];Logistic Models;Mammography [standards] [statistics & numerical data];Probability;Adult[checkword];Female[checkword];Humans[checkword];Male[checkword];adult; Bayes theorem; Breast Neoplasms/di [Diagnosis]; clinical competence; clinical trial; controlled study; decision making; female; Greece; human; male; mammography; medical education; multicenter study; probability; randomized controlled trial; standards; statistical analysis; statistical model; *statistics and numerical data
DOI: 10.4103/1357-6283.161846
AB: BACKGROUND: Residents are being increasingly challenged on how best to integrate diagnostic information in making decisions about patient care. The aim of this study is to assess the ability of residents to accurately integrate statistical data from a screening mammography test in order to estimate breast cancer probability and to investigate whether a simple alteration of the representation mode of probabilities into natural frequencies facilitates these computations. METHODS: A multi-institutional randomized controlled study of residents was performed in eight major hospitals in the city of Athens. Residents were asked to estimate the positive predictive value of the screening mammography test given its sensitivity and 1-specificity as well as the prevalence of breast cancer in the relevant population. One version of the scenario was presented in the single-event probability format that is commonly used in the medical literature, while the other used the natural frequency representation. The two questionnaire versions were randomly assigned to the participants. RESULTS: Out of 200 residents, 153 completed and returned the questionnaire (response rate 76.5%). Although more than one-third of the residents reported excellent or close to excellent familiarity with sensitivity and positive predictive value, the majority of responses (79.1%) were incorrect. However, a significantly higher proportion of residents in the natural frequency group (n = 88) selected the correct response compared with residents (n = 65) in the single-event probability group (28.4% vs 10.8%; 95% confidence intervals of the difference between the two proportions = 5.6-29.7%; P < 0.01). DISCUSSION: Residents more often correctly understand test performance accuracy when test characteristics are presented to them as natural frequency representations than the more common approach of presenting single event probabilities. Educators and journal editors should be aware of this facilitative effect.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/931/CN-01157931/frame.html

Record #41 of 90
ID: CN-00532513
AU: Armstrong K
AU: Weber B
AU: Ubel PA
AU: Peters N
AU: Holmes J
AU: Schwartz JS
TI: Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations
SO: Journal of clinical oncology
YR: 2005
VL: 23
NO: 36
PG: 9319-9328
PM: PUBMED 16361631
XR: EMBASE 46260190
PT: Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, Non-P.H.S.
KY: Anxiety;Breast Neoplasms [epidemiology] [genetics] [therapy];Decision Making;Decision Support Systems, Clinical;Double-Blind Method;Genes, BRCA1;Genes, BRCA2;Incidence;Patient Satisfaction;Prognosis;Risk Management;Survival Analysis;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];adult; anxiety; article; *breast cancer/dt [Drug Therapy]; *breast cancer/et [Etiology]; cancer incidence; cancer risk; *cancer survival; *cancer therapy; clinical article; clinical trial; controlled clinical trial; controlled study; female; follow up; gene mutation; hormone substitution; human; mastectomy; *medical decision making; outcome assessment; ovariectomy; *ovary cancer/et [Etiology]; patient satisfaction; priority journal; randomized controlled trial; survival rate; *BRCA1 protein/ec [Endogenous Compound]; *BRCA2 protein/ec [Endogenous Compound]; raloxifene; tamoxifen/dt [Drug Therapy]
CC: SR-BREASTCA: SR-GYNAECA
DOI: 10.1200/JCO.2005.06.119
AB: PATIENTS AND METHODSThis was a double-blind, randomized controlled trial of 32 women with BRCA1/2 mutations. Primary outcome measures were decision satisfaction, cancer anxiety, perceptions of cancer risk given alternative management strategies, and management decisions.RESULTSTwenty-seven women completed a 6-week follow-up. Women in the intervention arm (n = 13) reported significantly higher decision satisfaction at follow-up than women in the control arm (n = 14; adjusted mean difference, 9.7; P < .0005). The effect of the DSS was greater among women with low cancer anxiety at baseline than women with high cancer anxiety at baseline (P = .01 for interaction). However, the DSS did not significantly alter cancer anxiety at follow-up, perceptions of cancer risk given alternative management strategies, or management decisions.CONCLUSIONThe presentation of individualized survival and incidence curves for alternative management options improves satisfaction about cancer risk management decisions among women with BRCA1/2 mutations without increasing anxiety or changing management decisions. The benefit of the DSS is greatest among women with relatively low cancer-related anxiety at baseline.PURPOSEWomen with BRCA1/2 mutations are faced with complex decisions about breast and ovarian cancer risk management. This study was conducted to determine the effect of a tailored decision support system (DSS) that provides individualized survival and cancer incidence curves specific to expected outcomes of alternative management strategies.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/513/CN-00532513/frame.html

Record #42 of 90
ID: CN-01106134
AU: Berger-Hoger B
AU: Liethmann K
AU: Muhlhauser I
AU: Haastert B
AU: Steckelberg A
TI: Informed shared decision-making supported by decision coaches for women with ductal carcinoma in situ: Study protocol for a cluster randomized controlled trial.
SO: Trials
YR: 2015
VL: 16
NO: 1
XR: EMBASE 2015445304
PT: Journal: Article
KY: adult; article; clinical protocol; controlled study; *decision coaching; *decision making; evidence based practice; female; human; *informed shared decision making; *intraductal carcinoma/rt [Radiotherapy]; *intraductal carcinoma/su [Surgery]; nurse; outcome assessment; patient care; patient participation; physician; randomized controlled trial; *therapy
DOI: 10.1186/s13063-015-0991-8
AB: Background: Women with breast cancer want to participate in treatment decision-making. Guidelines have confirmed the right of informed shared decision-making. However, previous research has shown that the implementation of informed shared decision-making is suboptimal for reasons of limited resources of physicians, power imbalances between patients and physicians and missing evidence-based patient information. We developed an informed shared decision-making program for women with primary ductal carcinoma in situ (DCIS). The program provides decision coaching for women by specialized nurses and aims at supporting involvement in decision-making and informed choices. In this trial, the informed shared decision-making program will be evaluated in breast care centers. Methods/Design: A cluster randomized controlled trial will be conducted to compare the informed shared decision-making program with standard care. The program comprises an evidence-based patient decision aid and training of physicians (2hours) and specialized breast care and oncology nurses (4days) in informed shared decision-making. Sixteen certified breast care centers will be included, with 192 women with primary DCIS being recruited. Primary outcome is the extent of patients' involvement in shared decision-making as assessed by the MAPPIN-Odyad (Multifocal approach to the 'sharing' in shared decision-making: observer instrument dyad). Secondary endpoints include the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), informed choice, decisional conflict and the duration of encounters. It is expected that decision coaching and the provision of evidence-based patient decision aids will increase patients' involvement in decision-making with informed choices and reduce decisional conflicts and duration of physician encounters. Furthermore, an accompanying process evaluation will be conducted. Discussion: To our knowledge, this is the first study investigating the implementation of decision coaches in German breast care centers. Trial registration: Current Controlled Trials ISRCTN46305518 , date of registration: 5 June 2015.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/134/CN-01106134/frame.html

Record #43 of 90
ID: CN-00379899
AU: Rimer BK
AU: Halabi S
AU: Sugg Skinner C
AU: Lipkus IM
AU: Strigo TS
AU: Kaplan EB
AU: Samsa GP
TI: Effects of a mammography decision-making intervention at 12 and 24 months
SO: American journal of preventive medicine
YR: 2002
VL: 22
NO: 4
PG: 247-257
PM: PUBMED 11988381
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
KY: Breast Neoplasms [prevention & control];Counseling;Decision Making;Decision Support Techniques;Health Education [methods];Health Knowledge, Attitudes, Practice;Mammography [statistics & numerical data];North Carolina;Telephone;Time Factors;Adult[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-CANCER: SR-COMMUN
AB: METHODSWe conducted a randomized controlled trial, which ran from 1997 to 2000. Women aged 40 to 44 and 50 to 54, who were enrolled in Blue Cross Blue Shield of North Carolina, were randomly assigned to one of three groups: usual care (UC), tailored print (TP) materials, or TP plus tailored telephone counseling (TP+TC). We assessed the impact of tailored interventions on knowledge about breast cancer and mammography, accuracy of breast cancer risk perceptions, and use of mammography at two time points after intervention-12 and 24 months.RESULTSAt 12 and 24 months, women who received TP+TC had significantly greater knowledge and more accurate breast cancer risk perceptions. Compared to UC, they were 40% more likely to have had mammograms (odds ratio=0.9-2.1). The effect was primarily for women in their 50s. TP had significant effects for knowledge and accuracy, but women who received TP were less likely to have had mammography.CONCLUSIONSDecision-making interventions, comprised of two tailored print interventions (booklet and newsletter), delivered a year apart, with or without two tailored telephone calls, significantly increased knowledge and accuracy of perceived breast cancer risk at 12 and 24 months post-intervention. The effect on mammography use was significant in bivariate relationships but had a much more modest impact in multivariate analyses.BACKGROUNDMost women are not getting regular mammograms, and there is confusion about several mammography-related issues, including the age at which women should begin screening. Numerous groups have called for informed decision making about mammography, but few programs have resulted. Our research is intended to fill this gap.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/899/CN-00379899/frame.html

Record #44 of 90
ID: CN-00571237
AU: Tiller K
AU: Meiser B
AU: Gaff C
AU: Kirk J
AU: Dudding T
AU: Phillips KA
AU: Friedlander M
AU: Tucker K
TI: A randomized controlled trial of a decision aid for women at increased risk of ovarian cancer
SO: Medical decision making
YR: 2006
VL: 26
NO: 4
PG: 360-372
PM: PUBMED 16855125
XR: EMBASE 44050841
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Anxiety [etiology];Decision Making;Decision Support Techniques;Genetic Predisposition to Disease;Ovarian Neoplasms [genetics] [psychology] [therapy];Pamphlets;Patient Education as Topic;Patient Satisfaction;Female[checkword];Humans[checkword];Middle Aged[checkword];adult; article; breast cancer; cancer risk; clinical trial; colorectal cancer; controlled clinical trial; controlled study; decision aid; decision making; distress syndrome; family history; female; follow up; human; major clinical study; *ovary cancer; randomized controlled trial; risk management; scientific literature
CC: SR-GYNAECA: SR-HEALTHP
DOI: 10.1177/0272989X06290486
AB: METHODSThis randomized trial, conducted through 6 familial cancer centers, compared the efficacy of tailored decision aid to that of a general educational pamphlet in preparing women for decision making.PARTICIPANTS131 women with a family history of breast and/or ovarian cancer or of hereditary nonpolyposis colorectal cancer.OUTCOME MEASURESDecisional conflict, knowledge about ovarian cancer risk management options, and psychological adjustment were reassessed at 3 time points.RESULTSCompared to those who received the pamphlet (control), women who received the decision aid (intervention) were significantly more likely to report a high degree of acceptability of the educational material at both follow-up assessment time points. Findings indicate neither group experienced significant increases in psychological distress at either follow-up assessment time points relative to baseline. Two weeks postintervention, the intervention group demonstrated a significant decrease in decisional conflict compared to the control group (t = 2.4, P < 0.025) and a trend for a greater increase in knowledge about risk management options (t = 2.1, P = 0.037). No significant differences were found 6 months postintervention.CONCLUSIONThis form of educational material is successful in increasing knowledge about risk management options and in reducing decisional conflict in the shorter term. The decision aid is an effective and acceptable strategy for patient education to facilitate an inclusive and informed decision-making process about managing ovarian cancer risk.PURPOSETo carry out a randomized controlled trial of a decision aid for women at increased risk of developing ovarian cancer to facilitate decision making regarding risk management options.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/237/CN-00571237/frame.html

Record #45 of 90
ID: CN-01256200
AU: Klafke N
AU: Mahler C
AU: Hagens C
AU: Rochon J
AU: Schneeweiss A
AU: Müller A
AU: Salize HJ
AU: Joos S
TI: A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial
SO: Trials
YR: 2015
VL: 16
PG: 51
PM: PUBMED 25887713
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [psychology] [therapy];Complementary Therapies [nursing];Data Interpretation, Statistical;Genital Neoplasms, Female [psychology] [therapy];Outcome Assessment (Health Care);Quality Assurance, Health Care;Quality of Life;Sample Size;Social Support;Female[checkword];Humans[checkword]
DOI: 10.1186/s13063-014-0538-4
AB: METHODS/DESIGN: CONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM. Primary outcome data on participants' HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted. A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients.DISCUSSION: Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).BACKGROUND: Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/200/CN-01256200/frame.html

Record #46 of 90
ID: CN-01077267
AU: Shaffer VA
AU: Owens J
AU: Zikmund-Fisher BJ
TI: The effect of patient narratives on information search in a web-based breast cancer decision aid: an eye-tracking study.
SO: Journal of medical Internet research
YR: 2013
VL: 15
NO: 12
PG: e273
PM: PUBMED 24345424
XR: EMBASE 24345424
PT: Journal: Article
KY: adult; aged; article; breast cancer; *breast tumor/su [Surgery]; decision aids; decision making; *decision support system; eye movement; eye tracking; female; human; information seeking; *Internet; middle aged; patient participation; personal narratives; psychological aspect; *telemedicine; videorecording
AB: Previous research has examined the impact of patient narratives on treatment choices, but to our knowledge, no study has examined the effect of narratives on information search. Further, no research has considered the relative impact of their format (text vs video) on health care decisions in a single study. Our goal was to examine the impact of video and text-based narratives on information search in a Web-based patient decision aid for early stage breast cancer. Fifty-six women were asked to imagine that they had been diagnosed with early stage breast cancer and needed to choose between two surgical treatments (lumpectomy with radiation or mastectomy). Participants were randomly assigned to view one of four versions of a Web decision aid. Two versions of the decision aid included videos of interviews with patients and physicians or videos of interviews with physicians only. To distinguish between the effect of narratives and the effect of videos, we created two text versions of the Web decision aid by replacing the patient and physician interviews with text transcripts of the videos. Participants could freely browse the Web decision aid until they developed a treatment preference. We recorded participants' eye movements using the Tobii 1750 eye-tracking system equipped with Tobii Studio software. A priori, we defined 24 areas of interest (AOIs) in the Web decision aid. These AOIs were either separate pages of the Web decision aid or sections within a single page covering different content. We used multilevel modeling to examine the effect of narrative presence, narrative format, and their interaction on information search. There was a significant main effect of condition, P=.02; participants viewing decision aids with patient narratives spent more time searching for information than participants viewing the decision aids without narratives. The main effect of format was not significant, P=.10. However, there was a significant condition by format interaction on fixation duration, P<.001. When comparing the two video decision aids, participants viewing the narrative version spent more time searching for information than participants viewing the control version of the decision aid. In contrast, participants viewing the narrative version of the text decision aid spent less time searching for information than participants viewing the control version of the text decision aid. Further, narratives appear to have a global effect on information search; these effects were not limited to specific sections of the decision aid that contained topics discussed in the patient stories. The observed increase in fixation duration with video patient testimonials is consistent with the idea that the vividness of the video content could cause greater elaboration of the message, thereby encouraging greater information search. Conversely, because reading requires more effortful processing than watching, reading patient narratives may have decreased participant motivation to engage in more reading in the remaining sections of the Web decision aid. These findings suggest that the format of patient stories may be equally as important as their content in determining their effect on decision making. More research is needed to understand why differences in format result in fundamental differences in information search.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/267/CN-01077267/frame.html

Record #47 of 90
ID: CN-00787526
AU: Oostendorp LJ
AU: Ottevanger PB
AU: Graaf WT
AU: Stalmeier PF
TI: Assessing the information desire of patients with advanced cancer by providing information with a decision aid, which is evaluated in a randomized trial: a study protocol
SO: BMC medical informatics and decision making
YR: 2011
VL: 11
PG: 9
PM: PUBMED 21320319
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Antineoplastic Agents [therapeutic use];Decision Making;Decision Support Techniques;Neoplasms [drug therapy];Patient Education as Topic;Patient Participation;Socioeconomic Factors;Surveys and Questionnaires;Humans[checkword]
CC: SR-GYNAECA: SR-DEPRESSN
DOI: 10.1186/1472-6947-11-9
AB: METHODS/DESIGNThis study is a randomized controlled trial of patients with advanced colorectal, breast, or ovarian cancer who have started treatment with first-line palliative chemotherapy. The trial will consist of 100 patients in the decision aid group and 70 patients in the usual care group. To collect complete data of 170 patients, 246 patients will be approached for the study. Patients will complete a baseline questionnaire on sociodemographic data, well-being measures, and psychological measures, believed to predict information desire. The medical oncologist will judge the patient's information desire. After disease progression is diagnosed, the medical oncologist offers the choice between second-line palliative chemotherapy plus best supportive care (BSC) and BSC alone. Randomization will take place to determine whether patients will receive usual care (n = 70) or usual care and the decision aid (n = 100). The aid offers information about the potential risks and benefits of both treatment options, in terms of adverse events, tumour response, and survival. Patients decide for each item whether they desire the information or not. Two follow-up questionnaires will evaluate the effect of the decision aid.DISCUSSIONThis study attempts to settle the debate on the desirability of informing patients with cancer. In contrast to several earlier studies, we will actually deliver information on treatment options to patients at the point of decision making.BACKGROUNDThere is a continuing debate on the desirability of informing patients with cancer and thereby involving them in treatment decisions. On the one hand, information uptake may be hampered, and additional stress could be inflicted by involving these patients. On the other hand, even patients with advanced cancer desire information on risks and prognosis. To settle the debate, a decision aid will be developed and presented to patients with advanced disease at the point of decision making. The aid is used to assess the amount of information desired. Factors related to information desire are explored, as well as the ability of the medical oncologist to judge the patient's information desire. The effects of the information on patient well-being are assessed by comparing the decision aid group with a usual care group.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/526/CN-00787526/frame.html

Record #48 of 90
ID: CN-00753048
AU: Andrykowski MA
AU: Burris JL
AU: Walsh E
AU: Small BJ
AU: Jacobsen PB
TI: Attitudes toward information about genetic risk for cognitive impairment after cancer chemotherapy: breast cancer survivors compared with healthy controls
SO: Journal of clinical oncology
YR: 2010
VL: 28
NO: 21
PG: 3442-3447
PM: PUBMED 20498392
PT: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
KY: Attitude;Breast Neoplasms [drug therapy] [genetics] [psychology];Cognition Disorders [genetics];Decision Making;Genetic Predisposition to Disease;Risk;Survivors;Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA
DOI: 10.1200/JCO.2009.27.8267
AB: METHODS: One hundred sixty breast cancer survivors (BC group) and 205 healthy controls (HC group) were randomly assigned to respond to two different clinical scenarios varying in genetic-related risk of cognitive impairment (CI; little v very likely) and severity of CI (little v moderate problem) after chemotherapy. Ratings of the importance of being told this genetic information (information importance) and the likelihood this information would affect their decision to receive chemotherapy (information impact) were obtained.RESULTS: Results indicated the importance ascribed to genetic information was greatest when CI likelihood and severity were both high or low (P < .05). Information impact ratings were not sensitive to differences in CI likelihood or severity; the BC group was less likely to indicate genetic information would affect their decision to receive chemotherapy than the HC group (P < .001).CONCLUSION: Results suggest lessened enthusiasm for genetic information that maintains or increases uncertainty about a specific course of action and highlight the importance of including clinically relevant groups in treatment decision-making research that employs hypothetical scenarios. Although women generally believe it is important to receive genetic information, they might benefit from assistance (eg, decision aid) in the difficult task of integrating information about survival and risk for adverse late effects from cancer treatment.PURPOSE: The trend toward personalized medicine will involve cancer treatment increasingly being tailored to the genetic characteristics of individuals. However, the availability of genetic information does not imply this information is desired or would impact treatment decision making.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/048/CN-00753048/frame.html

Record #49 of 90
ID: CN-00802576
AU: Hooker GW
AU: Leventhal KG
AU: DeMarco T
AU: Peshkin BN
AU: Finch C
AU: Wahl E
AU: Joines JR
AU: Brown K
AU: Valdimarsdottir H
AU: Schwartz MD
TI: Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a randomized trial
SO: Medical decision making
YR: 2011
VL: 31
NO: 3
PG: 412-421
PM: PUBMED 20876346
PT: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
KY: Adaptation, Psychological;Breast Neoplasms [genetics] [psychology] [surgery];Decision Making, Computer-Assisted;Decision Support Techniques;Genes, BRCA1;Genes, BRCA2;Genetic Counseling [psychology];Longitudinal Studies;Mammography;Mastectomy;Multivariate Analysis;New York [epidemiology];Patient Education as Topic;Psychometrics;Risk Assessment;Stress, Psychological;Surveys and Questionnaires;Time Factors;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword];Young Adult[checkword]
DOI: 10.1177/0272989X10381283
AB: OBJECTIVE: In order to provide BRCA1/2 carriers with ongoing decision support for breast cancer risk management, a computer-based interactive decision aid was developed and tested against usual care in a randomized controlled trial.DESIGN: . Following genetic counseling, 214 female (aged 21-75 years) BRCA1/2 mutation carriers were randomized to usual care (UC; n = 114) or usual care plus decision aid (DA; n = 100) arms. UC participants received no further intervention; DA participants were sent the CD-ROM-based decision aid to view at home.MAIN OUTCOME MEASURES: The authors measured general distress, cancer-specific distress, and genetic testing-specific distress at 1-, 6-, and 12-month follow-up time points postrandomization.RESULTS: Longitudinal analyses revealed a significant longitudinal impact of the DA on cancer-specific distress (B = 5.67, z = 2.81, P = 0.005), which varied over time (DA group by time; B = -2.19, z = -2.47, P = 0.01), and on genetic testing-specific distress (B = 5.55, z = 2.46, P = 0.01), which also varied over time (DA group by time; B = -2.46, z = -2.51, P = 0.01). Individuals randomized to UC reported significantly decreased distress in the month following randomization, whereas individuals randomized to the DA maintained their postdisclosure distress over the short term. By 12 months, the overall decrease in distress between the 2 groups was similar.CONCLUSION: This report provides new insight into the long-term longitudinal effects of DAs.BACKGROUND: Increasingly, women with a strong family history of breast cancer are seeking genetic testing as a starting point to making significant decisions regarding management of their cancer risks. Individuals who are found to be carriers of a BRCA1 or BRCA2 mutation have a substantially elevated risk for breast cancer and are frequently faced with the decision of whether to undergo risk-reducing mastectomy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/576/CN-00802576/frame.html

Record #50 of 90
ID: CN-00787233
AU: Vodermaier A
AU: Caspari C
AU: Wang L
AU: Koehm J
AU: Ditsch N
AU: Untch M
TI: How and for whom are decision aids effective? Long-term psychological outcome of a randomized controlled trial in women with newly diagnosed breast cancer
SO: Health psychology
YR: 2011
VL: 30
NO: 1
PG: 12-19
PM: PUBMED 21299290
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Adaptation, Psychological;Breast Neoplasms [diagnosis] [psychology];Conflict (Psychology);Decision Making;Internal-External Control;Linear Models;Patient Education as Topic;Surveys and Questionnaires;Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-DEPRESSN: SR-EPOC
DOI: 10.1037/a0021648
AB: METHODSPatients (n = 111) were randomized into usual care, or a 20-min decision aid intervention plus an information brochure prior to consultation planning with the senior physician. The retention rate at 1 year was 88%.RESULTSLinear mixed model analyses demonstrated that the intervention group experienced less decisional conflict (p = .047; d = .19), which was driven by perceptions of a more effective choice (p = .029; d = .20) over time. Subgroup analyses revealed that patients in the intervention group who participated in chemotherapy decision making showed better long-term body image outcomes (p = .009; d = .44), which were mediated by reduced depressive coping (p = .049). No effects emerged for anxiety and depressive symptoms, or for quality of life. Internal health locus of control moderated group effects on 'uncertainty with the decision' (p = .003).CONCLUSIONSThe study results provide novel evidence on the role of individual differences and the mechanisms behind decision aid effectiveness, and demonstrate the long-term impact of decision aid interventions on some indices of well-being.OBJECTIVEThe current study evaluates the long-term psychological impact of a decision aid intervention for surgical and systemic treatment in women with newly diagnosed breast cancer from a previous reported randomized, controlled trial (Vodermaier et al., 2009).
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/233/CN-00787233/frame.html

Record #51 of 90
ID: CN-00812223
AU: Fagerlin A
AU: Dillard AJ
AU: Smith DM
AU: Zikmund-Fisher BJ
AU: Pitsch R
AU: McClure JB
AU: Greene S
AU: Alford SH
AU: Nair V
AU: Hayes DF
AU: Wiese C
AU: Ubel PA
TI: Women's interest in taking tamoxifen and raloxifene for breast cancer prevention: response to a tailored decision aid
SO: Breast cancer research and treatment
YR: 2011
VL: 127
NO: 3
PG: 681-688
PM: PUBMED 21442198
PT: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
KY: Anticarcinogenic Agents [therapeutic use];Breast Neoplasms [drug therapy] [prevention & control];Decision Making;Health Knowledge, Attitudes, Practice;Patient Education as Topic;Raloxifene Hydrochloride [therapeutic use];Selective Estrogen Receptor Modulators [therapeutic use];Tamoxifen [therapeutic use];Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1007/s10549-011-1450-1
AB: Although tamoxifen can prevent primary breast cancer, few women use it as a preventive measure. A second option, raloxifene, has recently been approved. The objective of the study was to determine women's interest in tamoxifen and raloxifene after reading a decision aid (DA) describing the risks and benefits of each medication. Women with 5-year risk of breast cancer ≥ 1.66 from two large health maintenance organizations were randomized to receive a DA versus usual care. After reading an on-line DA that discussed the risks and benefits of tamoxifen and raloxifene, women completed measures of risk perception, decisional conflict, behavioral intentions, and actual behavior related to tamoxifen and raloxifene. 3 months following the intervention, 8.1% of participants had looked for additional information about breast cancer prevention drugs, and 1.8% had talked to their doctor about tamoxifen and/or raloxifene. The majority, 54.7%, had decided to not take either drug, 0.5% had started raloxifene, and none had started tamoxifen. Participants were not particularly worried about taking tamoxifen or raloxifene and did not perceive significant benefits from taking these drugs. Over 50% did not perceive a change in their risk of getting breast cancer if they took tamoxifen or raloxifene. After reading a DA about tamoxifen and raloxifene, few women were interested in taking either breast cancer prevention drug.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/223/CN-00812223/frame.html

Record #52 of 90
ID: CN-01264268
AU: Jiang Y
AU: Sereika SM
AU: Bender CM
AU: Brufsky AM
AU: Rosenzweig MQ
TI: Beliefs in Chemotherapy and Knowledge of Cancer and Treatment Among African American Women With Newly Diagnosed Breast Cancer
SO: Oncology nursing forum
YR: 2016
VL: 43
NO: 2
PG: 180-189
PM: PUBMED 26906129
PT: Journal Article; Randomized Controlled Trial
KY: African Americans [psychology];Attitude to Health [ethnology];Breast Neoplasms [drug therapy] [psychology];Cross-Sectional Studies;Decision Making;Drug Therapy [psychology];Health Knowledge, Attitudes, Practice [ethnology];Ohio;Pennsylvania;Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1188/16.ONF.180-189
AB: DESIGN: Descriptive, cross-sectional study.
.SETTING: Six urban cancer centers in Western Pennsylvania and Eastern Ohio.
.SAMPLE: 101 African American women with newly diagnosed breast cancer. 
.METHODS: Secondary analysis using baseline data collected from participants in a randomized, controlled trial at their first medical oncology visit before the first cycle of chemotherapy.
.MAIN RESEARCH VARIABLES: Belief in chemotherapy, knowledge of cancer and recommended treatment, self-efficacy, healthcare system distrust, interpersonal processes of care, symptom distress, and quality of life.
.FINDINGS: African American women endorsed the necessity of chemotherapy. Most women did not know their tumor size, hormone receptors, specific therapy, or why chemotherapy was recommended to them. Women who perceived better interpersonal communication with physicians, less self-efficacy, or were less involved in their own treatment decision making held stronger beliefs about the necessity of chemotherapy. Women without financial difficulty or having stronger social functioning had more knowledge of their cancer and recommended chemotherapy. 
.CONCLUSIONS: African American women with newly diagnosed breast cancer generally agreed with the necessity of chemotherapy. Knowledge of breast cancer, treatment, and risk reduction through adjuvant therapy was limited.
.IMPLICATIONS FOR NURSING: Oncology nurses could help advocate for tailored educational programs to support informed decision making regarding chemotherapy acceptance for African American women.PURPOSE/OBJECTIVES: To examine beliefs regarding the necessity of chemotherapy and knowledge of breast cancer and its treatment in African American women with newly diagnosed breast cancer, and to explore factors associated with women's beliefs and knowledge.
.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/268/CN-01264268/frame.html

Record #53 of 90
ID: CN-01208510
AU: Savelberg W
AU: Moser A
AU: Smidt M
AU: Boersma L
AU: Haekens C
AU: Weijden T
TI: Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer.
SO: BMJ Open
YR: 2015
VL: 5
NO: 3) (no pagination
PM: PUBMED 25829374
XR: EMBASE 603571736
PT: Journal: Article
KY: article; *breast cancer/su [Surgery]; cancer staging; cancer surgery; clinical article; *clinical protocol; controlled study; cost effectiveness analysis; female; health care planning; human; intervention study; interview; outcome assessment; *patient decision making; qualitative research; quantitative analysis; randomized controlled trial; treatment outcome; breast; *breast cancer; *decision making; ethics; *female; *human; long term survival; mastectomy; partial mastectomy; patient; professional standard; radiotherapy; registration; satisfaction; *surgery; survival rate; therapy; university
DOI: 10.1136/bmjopen-2015-007698
AB: Background: The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients' informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to beta test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting. Methods/design: This paper concerns a preimplementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid. Ethics and dissemination: This protocol was approved by the Maastricht University Medical Centre (MUMC) ethics committee. The findings will be disseminated through peer-reviewed journal articles and presentations at national conferences. Findings will be used to finalise a multi-faceted implementation strategy to test the implementation of SDM and a patient decision aid in terms of cost-effectiveness, in a multicentre cluster randomised controlled trial (RCT). Study registration number: NTR4879. Copyright © 2015, BMJ. All rights reserved.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/510/CN-01208510/frame.html

Record #54 of 90
ID: CN-00968668
AU: Belkora J
AU: Stupar L
AU: O'Donnell S
AU: Loucks A
AU: Moore D
AU: Jupiter C
AU: Johnson N
AU: Wilson L
TI: Decision support by telephone: randomized controlled trial in a rural community setting.
SO: Patient education and counseling
YR: 2012
VL: 89
NO: 1
PG: 134-42
PM: PUBMED 22776761
PT: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [diagnosis] [economics] [psychology];Community-Based Participatory Research;Confidence Intervals;Cost-Benefit Analysis;Decision Making;Interviews as Topic;Quality of Health Care;Referral and Consultation [economics] [statistics & numerical data];Rural Health Services [organization & administration];Rural Population [statistics & numerical data];Self Efficacy;Social Support;Socioeconomic Factors;Surveys and Questionnaires;Telephone;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-EPOC
DOI: 10.1016/j.pec.2012.06.009
AB: OBJECTIVE: Our community-based participatory research partnership previously evaluated Consultation Planning (CP), a question-listing intervention delivered in-person. We now report on effectiveness, cost, and value of delivering CP by telephone (Tele-CP).METHODS: Between 2007 and 2010, we randomly assigned rural women with a diagnosis of breast cancer to receive Tele-CP or In-Person CP. We compared ratings of decision self-efficacy (0 minimum to 4 maximum) with a pre-specified non-inferiority margin of 15%. We also explored psychosocial and economic outcomes.RESULTS: Tele-CP (n=35) recipients reported mean decision self-efficacy ratings of 3.53 versus 3.44 for in-person (n=32). Under intent-to-treat analysis, we rejected the null hypothesis of greater than 0.52 inferiority for Tele-CP (95% CI for difference: -0.44 to 0.13, p=0.006). The intervention costs averaged $48 for Tele-CP versus $78 in-person (95% CI for difference: -$63 to $2). Mean willingness-to-pay was $154 for Tele-CP and $144 for in-person (95% CI for difference: -$88 to $108).CONCLUSION: Tele-CP was non-inferior to In-Person CP, cost no more, and was equally valued by patients.PRACTICE IMPLICATIONS: Telephone delivery of Consultation Planning can achieve comparable quality, cost, and value as in-person. Organizations offering Consultation Planning or similar question-listing interventions should consider adopting telephone delivery.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/668/CN-00968668/frame.html

Record #55 of 90
ID: CN-00701315
AU: Kunkler IH
AU: Prescott RJ
AU: Lee RJ
AU: Brebner JA
AU: Cairns JA
AU: Fielding RG
AU: Bowman A
AU: Neades G
AU: Walls AD
AU: Chetty U
AU: Dixon JM
AU: Smith ME
AU: Gardner TW
AU: Macnab M
AU: Swann S
AU: Maclean JR
TI: TELEMAM: a cluster randomised trial to assess the use of telemedicine in multi-disciplinary breast cancer decision making
SO: European journal of cancer (oxford, england : 1990)
YR: 2007
VL: 43
NO: 17
PG: 2506-2514
PM: PUBMED 17962011
XR: EMBASE 350103547
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Attitude of Health Personnel;Breast Neoplasms [economics] [therapy];Consumer Behavior;Costs and Cost Analysis;Decision Making;Hospitals, District;Patient Care Team;Rural Health;Scotland;Telemedicine [economics] [utilization];Treatment Outcome;Female[checkword];Humans[checkword];article; *breast cancer; clinical effectiveness; clinical trial; controlled clinical trial; controlled study; cost effectiveness analysis; female; human; major clinical study; male; mammography; medical decision making; outcome assessment; practice guideline; priority journal; randomized controlled trial; *telemedicine; videoconferencing
DOI: 10.1016/j.ejca.2007.08.026
AB: METHODSOver 12 months 473 MDT patient discussions in two district general hospitals (DGHs) were cluster randomised (2:1) to the intervention of telemedicine linkage to breast specialists in a cancer centre or to the control group of 'in-person' meetings. Primary endpoints were clinical effectiveness and costs. Economic analysis was based on a cost-minimisation approach.RESULTSLevels of agreement of MDT members on a scale from 1 to 5 were high and similar in both the telemedicine and standard meetings for decision sharing (4.04 versus 4.17), consensus (4.06 versus 4.20) and confidence in the decision (4.16 versus 4.07). The threshold at which the telemedicine meetings became cheaper than standard MDTs was approximately 40 meetings per year.CONCLUSIONTelemedicine delivered breast cancer multi-disciplinary meetings have similar clinical effectiveness to standard 'in-person' meetings.AIMThe TELEMAM trial aimed to assess the clinical effectiveness and costs of telemedicine in conducting breast cancer multi-disciplinary meetings (MDTs).
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/315/CN-00701315/frame.html

Record #56 of 90
ID: CN-01070776
AU: Savelberg W
AU: Moser A
AU: Smidt M
AU: Boersma L
AU: Haekens C
AU: Weijden T
TI: Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer.
SO: BMJ Open
YR: 2015
VL: 5
NO: 3
XR: EMBASE 2015903948
PT: Journal: Article
KY: article; *breast cancer/su [Surgery]; cancer staging; cancer surgery; clinical article; *clinical protocol; controlled study; cost effectiveness analysis; female; health care planning; human; intervention study; interview; outcome assessment; *patient decision making; qualitative research; quantitative analysis; randomized controlled trial; treatment outcome
DOI: 10.1136/bmjopen-2015-007698
AB: Background: The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients' informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to beta test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting. Methods/design: This paper concerns a preimplementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid. Ethics and dissemination: This protocol was approved by the Maastricht University Medical Centre (MUMC) ethics committee. The findings will be disseminated through peer-reviewed journal articles and presentations at national conferences. Findings will be used to finalise a multi-faceted implementation strategy to test the implementation of SDM and a patient decision aid in terms of cost-effectiveness, in a multicentre cluster randomised controlled trial (RCT). Study registration number: NTR4879.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/776/CN-01070776/frame.html

Record #57 of 90
ID: CN-01005662
AU: Rustveld L
AU: Jibaja-Weiss M
TI: A patchwork of life: A bilingual breast cancer treatment patient decision aid targeted at medically underserved women.
SO: Cancer Epidemiology Biomarkers and Prevention
YR: 2011
VL: 20
NO: 10 Meeting Abstracts
XR: EMBASE 70707122
PT: Journal: Conference Abstract
KY: *human; *health disparity; *patient; *breast cancer; *cancer research; *cancer therapy; *neoplasm; *female; *medically underserved; control group; reading; follow up; partial mastectomy; mastectomy; randomized controlled trial; questionnaire; decision making; Hispanic; risk; interpersonal communication; friend; procedures; satisfaction; computer; national health organization; pathology; medical record; physician; medical information; health; skill; information processing; African American; learning environment; learning; surgery; soap
DOI: 10.1158/1055-9965.DISP-11-A31
AB: Introduction: Most patient decision aids rely heavily on written information and require patients to have above average literacy skills, a potential barrier for the medically underserved. Individuals with limited literacy are restricted in their ability to make appropriate health decisions and to act on health information. We developed and evaluated the "A Patchwork of Life" (PLife) patient decision aid to assist medically underserved women with limited literacy in making a breast cancer treatment decision. The PLife is computer-based, culturally and linguistically appropriate learning environment that involves two key components, soap opera segments and related learning modules designed to support breast cancer (Stages I-IIIA) surgery decision-making and to encourage communication about treatment decision with their provider, relatives and friends. The objectives of the project were to: 1) determine the effectiveness of PLife in assisting patients make informed breast cancer treatment decisions, and; 2) evaluate patients' perceptions of the usefulness of the intervention for aiding in their decision-making. Experimental Procedures: The study was a randomized controlled trial including an intervention and control group. The intervention group viewed the PLife program and the control group received usual care including additional breast cancer educational material provided by the National Cancer Institute (NCI). Both groups consisted of patients who were candidates for lumpectomy or mastectomy. Patients were identified through pathology and other medical records and physician referrals. Those who consented completed all baseline assessments before implementation of the PLife decision aid. A Patient Navigator arranged for a convenient time for the patient to view the program. Immediately after viewing the program, patients answered a questionnaire rating the program. Follow-up data collection with patients took place via phone 2-weeks after viewing the program. At 2-week, and 6-month follow up patients answered questions about breast cancer knowledge, decisional conflict, and treatment preferences. Questionnaires were administered in Spanish and English. Summary of Data: A total of 100 patients diagnosed with Stage I-IIIA breast cancer were randomized to either a control (n = 49) or intervention group (n = 51). Median age of the sample was 49 + 11.6 years, 15% were Non-Hispanic White, 56% African American, and 49% Hispanic. The majority of patients chose mastectomy over lumpectomy, regardless of study group assignment (60.8% intervention vs 53.1% control). Intervention group exhibited greater improvement in breast cancer knowledge compared to control group (60.5% vs 37.7%, respectively). At six month follow-up, patients who viewed the PLife program felt more informed about their treatment options, risks and benefits (p = 0.01), and showed significant improvement in decision certainty about breast cancer treatment (p = 0.01) compared to control group. Usability analysis revealed a high level of user satisfaction with the PLife program. Conclusions: Results suggest that the PLife program improved patients' knowledge about breast cancer. Additionally, patients who interacted with the PLife program exhibited an overall greater treatment decision certainty compared to usual care group. Taken together, these findings suggest, that the PLife program is a suitable strategy to help medically underserved women with breast cancer maximize their understanding of the implications of breast cancer treatment options.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/662/CN-01005662/frame.html

Record #58 of 90
ID: CN-01141792
AU: Hawley ST
AU: Newman L
AU: Griggs JJ
AU: Kosir MA
AU: Katz SJ
TI: Evaluating a Decision Aid for Improving Decision Making in Patients with Early-stage Breast Cancer.
SO: Patient
YR: 2016
VL: 9
NO: 2
PG: 161-9
XR: EMBASE 2015197180
PT: Journal: Article
KY: adult; aged; article; *breast cancer; cancer patient; cancer staging; chi square test; clinical assessment tool; clinical evaluation; controlled study; *decision support system; female; health survey; human; knowledge; major clinical study; *patient decision making; patient preference; priority journal; randomized controlled trial; Student t test
DOI: 10.1007/s40271-015-0135-y
AB: Background: Early-stage breast cancer patients face a series of complex treatment decisions, with the first typically being choice of locoregional treatment. There is a need for tools to support patients in this decision-making process. Methods: We developed an innovative, online locoregional treatment tool based on International Patient Decision Aids Standards criteria. We evaluated its impact on patient knowledge about treatment and appraisal of decision making in a pilot study using a clinical sample of newly diagnosed, breast cancer patients who were randomized to view the decision aid website first or complete a survey prior to viewing the decision aid. Differences in knowledge and decision appraisal between the two groups were compared using t-tests and chi-square tests. Computer-generated preferences for treatment were compared with patients' stated preferences using chi-square tests. Results: One hundred and one newly diagnosed patients were randomized to view the website first or take a survey first. Women who viewed the website first had slightly higher, though not significantly, knowledge about surgery (p = 0.29) and reconstruction (p = 0.10) than the survey-first group. Those who viewed the website first also appraised their decision process significantly more favorably than did those who took the survey first (p < 0.05 for most decision outcomes). There was very good concordance between computer-suggested and stated treatment preferences. Conclusion: This pilot study suggests that an interactive decision tool shows promise for supporting early-stage breast cancer patients with complicated treatment decision making.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/792/CN-01141792/frame.html

Record #59 of 90
ID: CN-00411954
AU: Davison BJ
AU: Degner LF
TI: Feasibility of using a computer-assisted intervention to enhance the way women with breast cancer communicate with their physicians
SO: Cancer nursing
YR: 2002
VL: 25
NO: 6
PG: 417-424
PM: PUBMED 12464832
PT: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Adaptation, Psychological;Breast Neoplasms [psychology];Communication;Computer-Assisted Instruction [methods];Decision Making;Electronic Mail [organization & administration];Feasibility Studies;Internal-External Control;Manitoba;Needs Assessment;Patient Education as Topic [methods];Patient Participation;Patient Satisfaction;Physician-Patient Relations;Surveys and Questionnaires;Telemedicine [methods];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-COMMUN
AB: This study was conducted to evaluate the feasibility of using a computer intervention to enhance communication between healthcare professionals and women with breast cancer. Additional aims were to measure the extent to which women achieved their preferred decisional roles and satisfaction with the clinical medical appointment. This two-arm randomized clinical trial design included a convenience sample of 749 women with breast cancer attending 3 urban Canadian outpatient oncology clinics. Most women were older than 50 years and had a high school diploma or greater (57%). Women in the control group completed measures of decision preference before their clinic appointments. Women in the intervention group were encouraged to use the information and decision preference profiles generated by the computer program at their clinic appointments. Levels of involvement in decision making and satisfaction were measured after the clinic appointments. Results showed that although the majority of women in both groups did assume their preferred roles in decision making, a significantly higher proportion of women in the intervention group reported playing a more passive role than originally planned. Both groups reported high satisfaction levels. Future research is required to study how this computer intervention could be used by clinicians to provide information and decision support to these women.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/954/CN-00411954/frame.html

Record #60 of 90
ID: CN-00920162
AU: Platt J
AU: Baxter N
AU: Jones J
AU: Metcalfe K
AU: Causarano N
AU: Hofer SOP
AU: O'Neill A
AU: Cheng T
AU: Starenkyj E
AU: Zhong T
TI: Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: Study protocol for a pilot randomized controlled trial.
SO: Trials
YR: 2013
VL: 14
NO: 1
XR: EMBASE 2013443546
PT: Journal: Article
KY: adult // article // *breast reconstruction // cancer survivor // *consultation // controlled study // decision making // female // human // interview // *mastectomy // medical specialist // nurse // outcome assessment // pilot study // plastic surgeon // postoperative care // randomized controlled trial // social worker // support group // workshop
DOI: 10.1186/1745-6215-14-199
AB: Background: The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.Methods/design: This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada.Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired.Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.Discussion: Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013. 2013 Platt et al.; licensee BioMed Central Ltd.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/162/CN-00920162/frame.html

Record #61 of 90
ID: CN-01011361
AU: Sherman K
AU: Harcourt D
AU: Lam T
AU: Boyages J
AU: Brown P
AU: Cameron L
AU: Shaw L-K
AU: Winch C
TI: Facilitating decision making of women considering breast reconstruction following mastectomy: Results from a randomised controlled trial of the breconda web-based decision aid.
SO: Psycho-oncology
YR: 2013
VL: 22
PG: 22-3
XR: EMBASE 71356446
PT: Journal: Conference Abstract
KY: *human; *oncology; *breast reconstruction; *society; *mastectomy; *randomized controlled trial; *female; *decision making; satisfaction; follow up; patient; surgery; breast cancer; questionnaire; exercise; decision support system; diagnosis; plastic surgery; breast surgery; surgeon; population; Internet; consultation; interview; videorecording; breast; metronidazole
DOI: 10.1111/j.1099-1611.2013.3393
AB: BACKGROUND: Women requiring mastectomy for breast cancer are faced with the difficult preference- based decision regarding whether, and how, to restore breast shape after surgery. We have developed a web-based interactive decision aid, BRECONDA, to assist with this decision-making. Detailed information about type and timing of breast reconstruction surgical choices, interactive values clarification exercises, and video recorded patient interviews are provided. In a randomised controlled trial we compared the efficacy of BRECONDA with a general educational pamphlet. METHOD: Women diagnosed with breast cancer were recruited into the entirely web-based trial either prior to (n = 31) or after mastectomy (n = 107). Following consent, participants completed baseline questionnaires and were then randomly assigned into either: 1) Intervention (INT) - received unlimited access to the BRECONDA program and an electronic version of an information booklet about breast surgery and reconstruction; or, 2) Control (CONT) - received the information booklet alone. Participants then completed 1- month follow-up questionnaires. Assessments included satisfaction with information, decisional conflict and knowledge. INT participants completed ratings of perceived usefulness of the intervention and appropriateness and extent of the content. RESULTS: By 1-month follow-up, 26 participants (16 CONT; 10 INT) had undergone breast reconstruction. Controlling for baseline knowledge, time since diagnosis, current reconstruction and mastectomy status, ANCOVAs demonstrated that at follow-up INT participants reported significantly lower decisional conflict (INT = 27.3; CONT = 34.6, p = 0.015) and greater satisfaction with information (INT = 4.02; CONT = 3.74, p= 0.033); both groups had equally high knowledge (INT = 8.58; CONT = 8.41; out of 10; p= 0.47). The majority (>75%) of INT participants indicated high to very high overall satisfaction with the intervention, reporting that it was easy to use, presented a balanced view and that the amount of information provided was "just right" (75%). CONCLUSIONS: These findings indicate that participants assigned to the intervention benefitted in terms of their overall decisional process quality in that they reported both greater satisfaction with information regarding the breast reconstruction decision and lower decisional conflict. In terms of evaluating the content and format, intervention users reported high levels of user acceptability regarding overall satisfaction with the decision aid, and the appropriateness of the content for the target audience. Given that both conditions had access to quality information about breast reconstruction through the information booklet it is not surprising that knowledge was high in both groups at the 1-month follow-up. RESEARCH IMPLICATIONS: This is the first randomized controlled trial to assess a fully-integrated online decision aid that incorporates values clarification exercises in the breast reconstruction context. These findings provide evidence for the acceptability and efficacy of this decision support intervention in the short term. The intervention was equally as effective for women who had previously undergone mastectomy as for those about to have a mastectomy, suggesting the broad applicability of this decision aid. CLINICAL IMPLICATIONS: Online patient resources such as BRECONDA have the advantage of easy accessibility, particularly with increasing internet access across the broad population. These data support the feasibility and acceptability of implementing BRECONDA into oncological surgery practice. The easy-to-use self-guided format of the intervention will allow surgeons to refer their patients to this resource as an adjunct to medical consultations and to facilitate the decision-making process concerning both immediate and delayed breast reconstruction surgery following mastectomy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/361/CN-01011361/frame.html

Record #62 of 90
ID: CN-00529464
AU: Emery J
TI: The GRAIDS Trial: the development and evaluation of computer decision support for cancer genetic risk assessment in primary care
SO: Annals of human biology
YR: 2005
VL: 32
NO: 2
PG: 218-227
PM: PUBMED 16096220
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Attitude of Health Personnel;Attitude to Computers;Breast Neoplasms [genetics] [prevention & control];Colorectal Neoplasms [genetics] [prevention & control];Decision Making, Computer-Assisted;England;Genetics [education];Outcome Assessment (Health Care) [methods];Primary Health Care;Risk Assessment [methods];Female[checkword];Humans[checkword]
CC: SR-COLOCA
DOI: 10.1080/03014460500074921
AB: The development and evaluation of computer decision support for the assessment of cancer genetic risk in primary care is reported with two series of studies described: the RAGs (Risk Assessment in Genetics) studies and the GRAIDS (Genetic Risk Assessment in an Intranet and Decision Support) Trial. In the GRAIDS Trial, 45 general practices in Eastern England have been recruited and randomised. Comparison practices attend an educational session and receive clinical guidelines about familial breast and colorectal cancer. In the intervention practices a lead clinician is trained in cancer genetics and use of the GRAIDS software. The GRAIDS software is a simple pedigree-drawing program that implements clinical guidelines for familial breast and colorectal cancer and presents individualised information about breast cancer risk in a range of formats. Outcome measures of the trial include: frequency of software use, practitioners' attitudes towards the software, total number of referrals to secondary care about familial cancer and the proportion that meet regional referral criteria, and a patient-centred measure of informed decision making. The family history will become an increasingly important tool in primary care to assess genetic risk. This research evaluates an approach to support high-quality advice about cancer genetics in primary care which could be applied more broadly as our understanding of complex disease genetics increases.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/464/CN-00529464/frame.html

Record #63 of 90
ID: CN-01091958
AU: Sherman K
AU: Shaw L
AU: Winch C
AU: Harcourt D
AU: Cameron L
AU: Brown P
TI: Psychological distress, age and salience of physical appearance: Mediator and moderator effects of the BRECONDA web-based decision aid for women considering breast reconstruction following mastectomy.
SO: Psycho-oncology
YR: 2015
VL: 24
PG: 44
XR: EMBASE 71967879
PT: Journal: Conference Abstract
KY: *female; *human; *breast reconstruction; *mastectomy; *oncology; *distress syndrome; follow up; surgery; decision making; Internet; neoplasm; patient; breast cancer; randomized controlled trial; bootstrapping; exercise; model; breast; consultation; plastic surgery; population; surgeon; questionnaire
DOI: 10.1002/pon.3873
AB: BACKGROUND/PURPOSE: Women requiring mastectomy for breast cancer are faced with difficult decisions regarding whether, and how, to restore breast shape after surgery. We developed a web-based interactive decision aid, BRECONDA, to assist women with this decision making. Using data from the BRECONDA randomized controlled trial (RCT), this study examined moderators and mediators of decisional conflict and decisional regret. METHODS: Women diagnosed with breast cancer (N= 265) were recruited into the web-based RCT. Participants completed baseline questionnaires and were randomly assigned to either the BRECONDA Intervention (INT) or Usual Care (CONT) conditions. Age and psychological distress at study entry were assessed as moderators, and values about minimizing additional surgical intervention and physical appearance-related concerns were assessed as mediators of BRECONDA. Decisional conflict and decisional regret were assessed at 1- and 6-month follow-up. RESULTS: Linear mixed effects models demonstrated a moderating effect of age and cancer-specific distress on decisional conflict: INT participants who were older and more distressed demonstrated the greatest reduction in decisional conflict at 1- and 6-month follow-up. Mediation bootstrapping analysis revealed that participant values about physical appearancerelated concerns at 1-month follow-up mediated the impact of BRECONDA on decisional conflict and regret at 6-month follow-up. CONCLUSIONS: This is the first RCT to assess a fully integrated online decision aid that incorporates values clarification exercises in the breast reconstruction context. These findings delineate the characteristics of individuals most likely to benefit from the BRECONDA decision aid and a mechanism by which the intervention demonstrates decisional process benefits to women considering breast reconstruction. Research Implications: Prior research has identified the efficacy of the BRECONDA intervention in reducing decisional conflict and decisional regret in women faced with the breast reconstruction decision. These findings delineate the characteristics of individuals most likely to benefit from the BRECONDA decision aid and a mechanism by which the intervention facilitates the decision-making process. Older women, who are typically less extensive users of the Internet, and those experiencing greater levels of cancer-specific distress at the point of study entry, have particularly benefitted from the provision of quality, structured information concerning breast reconstruction options. The mediating effect of attitudinal change regarding the relative importance of physical appearance-related values when considering breast reconstruction highlights the key role of these views when making these surgical decisions. Practice Implications: Online patient resources such as BRECONDA have the advantage of easy accessibility, particularly with increasing Internet access across the broad population. These data support the use of this decisional support resource in oncological surgery practice and identify individuals for whom provision of this resource should be highly recommended and emphasized. The easy-to-use self-guided format of the intervention will allow surgeons to refer their patients to this resource as an adjunct to medical consultations and to facilitate the decision-making process concerning both immediate and delayed breast reconstruction surgery following mastectomy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/958/CN-01091958/frame.html

Record #64 of 90
ID: CN-00521495
AU: Green MJ
AU: Peterson SK
AU: Baker MW
AU: Friedman LC
AU: Harper GR
AU: Rubinstein WS
AU: Peters JA
AU: Mauger DT
TI: Use of an educational computer program before genetic counseling for breast cancer susceptibility: effects on duration and content of counseling sessions
SO: Genetics in medicine
YR: 2005
VL: 7
NO: 4
PG: 221-229
PM: PUBMED 15834239
PT: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
KY: Breast Neoplasms [genetics];Decision Making, Computer-Assisted;Genetic Counseling [methods];Genetic Testing [methods];Health Knowledge, Attitudes, Practice;Patient Education as Topic;Patient Satisfaction;Software;Female[checkword];Humans[checkword]
CC: SR-COMMUN: SR-HEALTHP
AB: METHODS: We developed and evaluated an interactive computer program that educates women about breast cancer, heredity, and genetic testing. Between May 2000 and September 2002, women at six study sites were randomized into either: Counselor Group (n = 105), who received standard genetic counseling, or Computer Group (n = 106), who used the interactive computer program before counseling. Clients and counselors both evaluated the effectiveness of counseling sessions, and counselors completed additional measures for the Computer Group. Counselors also recorded the duration of each session.RESULTS: Baseline characteristics did not differ significantly between groups. Participants and counselors both rated the counseling sessions as highly effective, whether or not the sessions were preceded by computer use. Computer use resulted in significantly shorter counseling sessions among women at low risk for carrying BRCA1/2 mutations. In approximately half of the sessions preceded by clients' computer use, counselors indicated that clients' use of the computer program affected the way they used the time, shifting the focus away from basic education toward personal risk and decision-making.CONCLUSION: This study shows that the interactive computer program "Breast Cancer Risk and Genetic Testing" is a valuable adjunct to genetic counseling. Its use before counseling can shorten counseling sessions and allow counselors to focus more on the clients' individual risks and specific psychological concerns. As the demand for counseling services increases, a program such as this can play a valuable role in enhancing counseling efficiency.PURPOSE: Patients seeking genetic testing for inherited breast cancer risk are typically educated by genetic counselors; however, the growing demand for cancer genetic testing will likely exceed the availability of counselors trained in this area. We compared the effectiveness of counseling alone versus counseling preceded by use of a computer-based decision aid among women referred to genetic counseling for a family or personal history of breast cancer.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/495/CN-00521495/frame.html

Record #65 of 90
ID: CN-00570834
AU: Wilson BJ
AU: Torrance N
AU: Mollison J
AU: Watson MS
AU: Douglas A
AU: Miedzybrodzka Z
AU: Gordon R
AU: Wordsworth S
AU: Campbell M
AU: Haites N
AU: Grant A
TI: Cluster randomized trial of a multifaceted primary care decision-support intervention for inherited breast cancer risk
SO: Family practice
YR: 2006
VL: 23
NO: 5
PG: 537-544
PM: PUBMED 16787957
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Breast Neoplasms [genetics] [prevention & control];Clinical Competence;Decision Making, Computer-Assisted;Decision Support Systems, Clinical;Family Practice [education] [standards];Genetic Predisposition to Disease;Genetic Testing;Guideline Adherence;Patient Education as Topic [standards];Practice Guidelines as Topic;Referral and Consultation [utilization];Risk Assessment;Scotland;Software Design;Female[checkword];Humans[checkword]
CC: SR-BREASTCA: SR-COMMUN: SR-EPOC
DOI: 10.1093/fampra/cml026
AB: OBJECTIVETo evaluate the effectiveness of the intervention in improving GP confidence in managing patients concerned about genetic risk of breast cancer.METHODSDESIGNCluster randomized controlled trial.SETTINGGeneral practices in the Grampian region of Scotland.SUBJECTSGPs and the patients they referred for genetic counselling for risk of breast cancer.MAIN OUTCOME MEASURESGPs' self-reported confidence in four activities related to genetics; rates of referral of patients at elevated genetic risk; and referred patients' understanding of cancer risk factors.RESULTSNo statistically significant differences were observed between intervention and control arms in the primary or secondary outcomes. A possible effect of the intervention on the proportion of referred patients who were at elevated risk could not be discounted. Only a small proportion of intervention GPs attended the educational session, were aware or the software, or made use of it in practice.CONCLUSIONSNo convincing evidence of the effectiveness of the intervention was found, probably reflecting barriers to its use in routine practice.BACKGROUNDGPs are increasingly expected to meet the needs of patients concerned about their risk of inherited breast cancer, but may lack skills or confidence to use complex management guidelines. We developed an evidence-based, multifaceted intervention intended to promote confidence and skills in this area.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/834/CN-00570834/frame.html

Record #66 of 90
ID: CN-01259496
AU: Härter M
AU: Buchholz A
AU: Nicolai J
AU: Reuter K
AU: Komarahadi F
AU: Kriston L
AU: Kallinowski B
AU: Eich W
AU: Bieber C
TI: Shared Decision Making and the Use of Decision Aids
SO: Deutsches arzteblatt international
YR: 2015
VL: 112
NO: 40
PG: 672-679
PM: PUBMED 26517595
PT: Journal Article; Randomized Controlled Trial
KY: Clinical Decision-Making [methods];Evidence-Based Medicine;Germany [epidemiology];Neoplasms [epidemiology] [psychology] [therapy];Patient Participation [psychology] [statistics & numerical data];Patient Satisfaction [statistics & numerical data];Patient-Centered Care [statistics & numerical data];Physician-Patient Relations;Physicians [psychology] [statistics & numerical data];Prevalence;Quality Improvement [statistics & numerical data];Quality of Health Care [statistics & numerical data];Treatment Outcome;Adult[checkword];Female[checkword];Humans[checkword];Male[checkword];Middle Aged[checkword]
DOI: 10.3238/arztebl.2015.0672
AB: METHODSPhysicians who treat patients with cancer were invited to participate in a cluster-randomized trial and carry out SDM together with breast or colon cancer patients who faced decisions about their treatment. Decision-related physician-patient conversations were recorded. The patients filled out questionnaires immediately after the consultations (T1) and three months later (T2). The primary endpoints were the patients' confidence in and satisfaction with the decisions taken. The secondary endpoints were the process of decision making, anxiety, depression, quality of life, and externally assessed physician competence in SDM. The physicians in the intervention group underwent 12 hours of training in SDM, including the use of decision aids.RESULTSOf the 900 physicians invited to participated in the trial, 105 answered the invitation. 86 were randomly assigned to either the intervention group or the control group (44 and 42 physicians, respectively); 33 of the 86 physicians recruited at least one patient for the trial. A total of 160 patients participated in the trial, of whom 55 were treated by physicians in the intervention group. There were no intergroup differences in the primary endpoints. Trained physicians were more competent in SDM (Cohen's d = 0.56; p<0.05). Patients treated by trained physicians had lower anxiety and depression scores immediately after the consultation (d = -0.12 and -0.14, respectively; p<0.10), and markedly lower anxiety and depression scores three months later (d = -0.94 and -0.67, p<0.01).CONCLUSIONWhen physicians treating cancer patients improve their competence in SDM by appropriate training, their patients may suffer less anxiety and depression. These effects merit further study.BACKGROUNDIn shared decision making (SDM), the patient and the physician reach decisions in partnership. We conducted a trial of SDM training for physicians who treat patients with cancer.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/496/CN-01259496/frame.html

Record #67 of 90
ID: CN-00993547
AU: Wilson L
AU: Loucks A
AU: Stupar L
AU: O'Donnell S
AU: Moore D
AU: Belkora J
TI: Cost-benefit analysis of decision support methods for patients with breast cancer in a rural community.
SO: Community oncology
YR: 2013
VL: 10
NO: 2
PG: 47-57
XR: EMBASE 2014325834
PT: Journal: Article
KY: adult; article; audio recording; *breast cancer/dm [Disease Management]; cancer center; comparative study; consultation; controlled study; *cost benefit analysis; *decision support system; female; health care survey; human; major clinical study; middle aged; patient participation; randomized controlled trial; *rural population; sensitivity analysis
AB: Background Decision support interventions help patients who are facing difficult treatment decisions and improve shared decision making. There is little evidence of the economic impact of these interventions. Objective To determine the costs of providing a decision support intervention in the form of consultation planning (CP) and consultation planning with recording and summary (CPRS) to women with breast cancer and to compare the cost benefit of CP and CPRS by telephone versus in person. Methods Sixty-eight women with breast cancer who were being treated at a rural cancer resource center were randomized to CP in person or by telephone. All participants were then provided with an audio-recording of the physician consultation along with a typed summary for the full intervention (CPRS). Surveys completed by the participants and center staff provided data for measuring costs and willingness-to-pay (WTP) benefits. Societal perspective costs and incremental net benefit (INB) across delivery methods was determined. Results Total CP costs were $208.72 for telephone and $264.00 for in-person delivery. Significantly lower telephone-group costs (P < .001) were a result of lower participant travel expenses. Participants were willing to pay $154.12 for telephone and $144.03 for in-person CP (P = .85). WTP did not exceed costs of either delivery method compared with no intervention. INB of providing CP for telephone versus in person was $65.37, favoring telephone delivery. Sensitivity analysis revealed that with more efficient CP training, WTP became greater than the costs of delivering CP by telephone versus no intervention. Limitations There may be some income distribution effects in the measurement of WTP. Conclusions Providing CP by telephone was significantly less costly with no significant difference in benefit. Participants' WTP only exceeded the full cost of CP with more efficient training or higher participant volume. A positive INB showed telephone delivery is efficient and may increase accessibility to decision support services, particularly in rural communities. 2013 Frontline Medical Communications.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/547/CN-00993547/frame.html

Record #68 of 90
ID: CN-00331851
AU: Connelly MT
AU: Rusinak D
AU: Livingston W
AU: Raeke L
AU: Inui TS
TI: Patient knowledge about hormone replacement therapy: implications for treatment
SO: Menopause (new york, N.Y.)
YR: 2000
VL: 7
NO: 4
PG: 266-272
PM: PUBMED 10914620
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Alzheimer Disease [prevention & control];Breast Neoplasms [chemically induced];Colonic Neoplasms [prevention & control];Estrogen Replacement Therapy [adverse effects];Heart Diseases [prevention & control];Hip Fractures [prevention & control];Knowledge;Menopause;Osteoporosis, Postmenopausal [prevention & control];Patient Education as Topic;Placebos;Risk Factors;Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-CANCER: SR-COLOCA: SR-COMMUN
AB: DESIGNPreintervention telephone survey of 156 women enrolled in a randomized, placebo-controlled trial of HRT decision aids.RESULTSThe mean rating of menopause knowledge, on a scale from 1 to 10, with 10 indicating being "extremely knowledgeable," was 5.6 (range = 0-10) and of HRT was 4.2 (range = 0-9). The mean summary score for the explicit HRT knowledge test, on a 16-point scale, was 7.8 (range = 0-15). After adjustment for demographic characteristics and exposure to a provider conversation, higher income, white race, and the provider discussion were significant correlates of knowledge. Explicit knowledge was positively correlated with self-assessed menopause knowledge and HRT knowledge (Spearman's correlation coefficient = 0.39 and 0.52, respectively; p < 0.0001). Greater knowledge was not associated with intention to use HRT 1 year later. Women who had greater knowledge reported less conflict about the HRT decision (Spearman's correlation coefficient = -0.32; p < 0.0001).CONCLUSIONSA global question about level of knowledge is an effective clinical tool for identifying patients who are in need of additional education about HRT and menopause in this managed care population. Increased knowledge may decrease women's conflict about the HRT decision. Having had a previous conversation about menopause with a primary care provider is associated with greater knowledge about HRT.OBJECTIVETo determine whether women's global self-assessment of their knowledge about hormone replacement therapy (HRT) corresponds to their performance on an explicit knowledge test about HRT and to measure associations among knowledge, personal characteristics, decision conflict, and intention to use HRT.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/851/CN-00331851/frame.html

Record #69 of 90
ID: CN-01172522
AU: Cookson S
AU: Cawrse N
AU: Olsen S
TI: Evaluation of the benefits of breast reconstruction information evenings.
SO: European Journal of Surgical Oncology. Conference: Association of Breast Surgery Conference and AGM, ABS 2015 Bournemouth United Kingdom. Conference Start: 20150615 Conference End: 20150616. Conference Publication: (var.pagings)
YR: 2015
VL: 41
NO: 6
PG: S77
XR: EMBASE 72214451
PT: Journal: Conference Abstract
KY: *breast reconstruction; *breast surgery; human; female; peer group; medical audit; health care personnel; neoplasm; decision making; nursing staff; surgery; patient; medical specialist; support group; hospital design; volunteer; questionnaire; nurse; hospital
DOI: 10.1016/j.ejso.2015.03.220
AB: Introduction: Women considering breast reconstruction face many difficult choices. Breast reconstruction information evenings were initiated at the Royal Devon & Exeter Hospital (RD&E) in 2011 to provide information and peer support for women considering breast reconstruction. They are facilitated by the Breast Reconstruction Nurse Specialist and supported by medical and nursing staff. Information evenings are held three times a year at the local cancer support centre and are advertised in advance. The aim of the audit was assess the value of peer support and the benefit of providing information in a group setting. Method: Questionnaires were handed out to all women at consecutive information evenings between July 2011 and November 2014. The audit was based on the standard hospital design for auditing support groups. Results: 10 meetings have been held at the RD&E attended by a total of 171 women. The response rate was 58%. (100/171) 100% (100) of respondents would recommend the evening to other women considering breast reconstruction. 90% (90) women valued meeting and talking to the patient volunteers and seeing the results of surgery. 80% (80) women valued talking to healthcare professionals in this setting. 60% (60) women felt the evening supported their decision to go ahead with breast reconstruction. Conclusions: Women value peer support from women who have already had a breast reconstruction. This may help in their decision making. Women valued the opportunity to talk to healthcare professionals. Providing information on breast reconstruction in this format has been well received.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/522/CN-01172522/frame.html

Record #70 of 90
ID: CN-01288286
AU: Speck RM
AU: Neuman MD
AU: Resnick KS
AU: Mellers BA
AU: Fleisher LA
TI: Anticipated regret in shared decisionmaking: a randomized experimental study
SO: Perioperative medicine
YR: 2016
VL: 5
NO: 1) (no pagination
XR: EMBASE 613211560
PT: Journal: Article
KY: adult; article; *breast cancer; controlled study; female; health survey; human; human experiment; medical decision making; normal human; partial mastectomy; pilot study; priority journal; quality of life; randomized controlled trial; young adult; control group; controlled clinical trial; experimental model; *experimental study; lumpectomy; major clinical study; recipient; *Shared decision-making; statistical significance; surgery; surgical patient; volunteer
DOI: 10.1186/s13741-016-0031-6
AB: Background: Explicit consideration of anticipated regret is not part of the standard shared decision-making protocols. This pilot study aimed to compare decisions about a hypothetical surgery for breast cancer and examined whether regret is a consideration in treatment decisions. Methods: In this randomized experimental study, 184 healthy female volunteers were randomized to receive a standard decision aid (control) or one with information on post-surgical regret (experimental). The main outcome measures were the proportion of subjects choosing lumpectomy vs. mastectomy and the proportion reporting that regret played a role in the decision made. We hypothesized that a greater proportion of the experimental group (regret-incorporated decision aid) would make a surgical treatment preference that favored the less regret-inducing option and that they would be more likely to consider regret in their decision-making process as compared to the control group. Results: A significantly greater proportion of the experimental group subjects reported regret played a role in their decision-making process compared to the control counterparts (78 vs. 65 %; p = 0.039). Recipients of the regretincorporated experimental decision aid had a threefold increased odds of choosing the less regret-inducing surgery (OR = 2.97; 95 % CI = 1.25, 7.09; p value = 0.014). Conclusions: In this hypothetical context, the incorporation of regret in a decision aid for preference-sensitive surgery impacted decision-making. This finding suggests that keying in on anticipated regret may be an important element of shared decision-making strategies. Our results make a strong argument for applying this design and pursuing further research in a surgical patient population. Copyright © 2016 Speck et al.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/286/CN-01288286/frame.html

Record #71 of 90
ID: CN-01333689
AU: Collins K
AU: Wyld L
AU: Burton M
AU: Lifford K
AU: Armitage F
TI: Breast clinical nurse specialist perspective of decision support interventions
SO: European journal of surgical oncology. Conference: association of breast surgery conference, ABS 2016. United kingdom. Conference start: 20160516. Conference end: 20160517
YR: 2016
VL: 42
NO: 5
PG: S8
XR: EMBASE 614540583
PT: Journal: Conference Abstract
KY: *breast cancer; cancer therapy; *clinical nurse specialist; clinical practice; clinical study; consultation; controlled clinical trial; controlled study; *decision support system; doctor patient relation; female; human; interview; oncologist; questionnaire; randomized controlled trial; shared decision making; surgeon; telephone; validity; volunteer
DOI: 10.1016/j.ejso.2016.02.043
AB: Introduction: Treatment protocols for older women with breast cancer may vary from standard to accommodate co-morbidity and frailty. Supporting decision-making in older women may be challenging due to lack of informational resources and research evidence. We report development of tools to support shared decision making in older women from the perspective of the Clinical Nurse Specialist (CNS). Method: The information preferences of older women were studied using a multi-source intervention. CNS's, oncologists, surgeons, patients and healthy volunteers were recruited for questionnaires, audio recorded consultations, telephone and face to face interviews to determine the information needs of older women. Data were used to develop a series of decision support interventions (DESI's) to aid older women making breast cancer treatment decisions. These DESI's comprised patient booklets, a web based algorithm allowing clinicians to establish individual risks and option grids. User feedback on the tools was obtained to refine them further. Results: This abstract reports a re-interpretation of the data collected from a CNS perspective of the decision supports using framework analysis to identify common themes in the feedback to further refine the DESI's to facilitate clinical utility, acceptability, ease of use, practicality and facilitators and barriers to routine clinical practice. Conclusions: The decision tools were well received by CNSs whose feedback directed further amendments and addition of a 'frequently asked questions' section related to the sources and validity of underpinning data. This tool will now be tested as part of the Age Gap randomised trial.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/689/CN-01333689/frame.html

Record #72 of 90
ID: CN-01244748
AU: Speck RM
AU: Neuman MD
AU: Resnick KS
AU: Mellers BA
AU: Fleisher LA
TI: Anticipated regret in shared decisionmaking: a randomized experimental study
SO: Perioperative medicine
YR: 2016
VL: 5
NO: 1) (no pagination
XR: EMBASE 613211560
PT: Journal: Article
KY: *breast cancer; control group; controlled clinical trial; controlled study; experimental model; *experimental study; female; human; lumpectomy; major clinical study; randomized controlled trial; recipient; *shared decision making; statistical significance; surgery; surgical patient; volunteer
DOI: 10.1186/s13741-016-0031-6
AB: Background: Explicit consideration of anticipated regret is not part of the standard shared decision-making protocols. This pilot study aimed to compare decisions about a hypothetical surgery for breast cancer and examined whether regret is a consideration in treatment decisions. Methods: In this randomized experimental study, 184 healthy female volunteers were randomized to receive a standard decision aid (control) or one with information on post-surgical regret (experimental). The main outcome measures were the proportion of subjects choosing lumpectomy vs. mastectomy and the proportion reporting that regret played a role in the decision made. We hypothesized that a greater proportion of the experimental group (regret-incorporated decision aid) would make a surgical treatment preference that favored the less regret-inducing option and that they would be more likely to consider regret in their decision-making process as compared to the control group. Results: A significantly greater proportion of the experimental group subjects reported regret played a role in their decision-making process compared to the control counterparts (78 vs. 65 %; p = 0.039). Recipients of the regretincorporated experimental decision aid had a threefold increased odds of choosing the less regret-inducing surgery (OR = 2.97; 95 % CI = 1.25, 7.09; p value = 0.014). Conclusions: In this hypothetical context, the incorporation of regret in a decision aid for preference-sensitive surgery impacted decision-making. This finding suggests that keying in on anticipated regret may be an important element of shared decision-making strategies. Our results make a strong argument for applying this design and pursuing further research in a surgical patient population. Copyright © 2016 Speck et al.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/748/CN-01244748/frame.html

Record #73 of 90
ID: CN-01201031
AU: Fontein DB
AU: Klinten Grand M
AU: Nortier JW
AU: Seynaeve C
AU: Meershoek-Klein Kranenbarg E
AU: Dirix LY
AU: Velde CJ
AU: Putter H
TI: Dynamic prediction in breast cancer: proving feasibility in clinical practice using the TEAM trial.
SO: Annals of oncology : official journal of the European Society for Medical Oncology
YR: 2015
VL: 26
NO: 6
PG: 1254-62
PM: PUBMED 25862439
PT: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Antineoplastic Agents, Hormonal [adverse effects] [therapeutic use];Belgium;Biomarkers, Tumor [analysis];Breast Neoplasms [chemistry] [mortality] [pathology] [therapy];Chemotherapy, Adjuvant;Decision Support Techniques;Feasibility Studies;Mastectomy [adverse effects] [mortality];Neoplasm Recurrence, Local;Neoplasm Staging;Netherlands;Nomograms;Patient Selection;Predictive Value of Tests;Receptor, ErbB-2 [analysis];Risk Assessment;Risk Factors;Survival Analysis;Time Factors;Treatment Outcome;Adult[checkword];Aged[checkword];Aged, 80 and over[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1093/annonc/mdv146
AB: BACKGROUND: Predictive models are an integral part of current clinical practice and help determine optimal treatment strategies for individual patients. A drawback is that covariates are assumed to have constant effects on overall survival (OS), when in fact, these effects may change during follow-up (FU). Furthermore, breast cancer (BC) patients may experience events that alter their prognosis from that time onwards. We investigated the 'dynamic' effects of different covariates on OS and developed a nomogram to calculate 5-year dynamic OS (DOS) probability at different prediction timepoints (tP) during FU.METHODS: Dutch and Belgian postmenopausal, endocrine-sensitive, early BC patients enrolled in the TEAM trial were included. We assessed time-varying effects of specific covariates and obtained 5-year DOS predictions using a proportional baselines landmark supermodel. Covariates included age, histological grade, hormone receptor and HER2 status, T- and N-stage, locoregional recurrence (LRR), distant recurrence, and treatment compliance. A nomogram was designed to calculate 5-year DOS based on individual characteristics.RESULTS: A total of 2602 patients were included (mean FU 6.2 years). N-stage, LRR, and HER2 status demonstrated time-varying effects on 5-year DOS. Hazard ratio (HR) functions for LRR, high-risk N-stage (N2/3), and HER2 positivity were HR = (8.427 × 0.583[Formula: see text], HR = (3.621 × 0.816[Formula: see text], and HR = (1.235 × 0.851[Formula: see text], respectively. Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)]. All other covariates were time-constant.DISCUSSION: The current nomogram accounts for elapsed time since starting adjuvant endocrine treatment and optimizes prediction of individual 5-year DOS during FU for postmenopausal, endocrine-sensitive BC patients. The nomogram can facilitate in determining whether further therapy will benefit an individual patient, although validation in an independent dataset is still needed.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/031/CN-01201031/frame.html

Record #74 of 90
ID: CN-01139373
AU: Muhlbauer V
AU: Muhlhauser I
AU: Steckelberg A
TI: Analysis of prognostication and treatment benefit tools for women with early breast cancer as a prerequisite for informed shared decision making.
SO: Oncology Research and Treatment
YR: 2016
VL: 39
PG: 49
XR: EMBASE 72212444
PT: Journal: Conference Abstract
KY: *human; *female; *breast cancer; *decision making; German (citizen); risk; survival; death; randomized controlled trial (topic); cancer prognosis; data base; prognosis; Medline; Internet; adjuvant therapy; European; model; comorbidity; evidence based practice; randomized controlled trial; cancer mortality; cancer diagnosis; neoplasm; interpersonal communication; Germany; adjuvant
DOI: 10.1159/000444354
AB: Background: Shared decision making (SDM) is strongly recommended in the German treatment guideline for breast cancer. Following evidence-based criteria informed SDM requires decision aids that are based on individualized risk information rather than mere cancer prognosis such as 5-year relative survival. Treatment decisions should be based on individual prognostic data that include comorbidities and age-dependent risk of death from causes other than breast cancer. Methods: Systematic literature search in Pubmed and EMBASE and free internet search. Prognostication tools for women with early, ER-positive breast cancer were analyzed for incorporated variables, information on the prognosis without adjuvant therapy, underlying data base, model validation and being up-to-date. Results: We identified 3 relevant prognostication tools on survival: Adjuvant!, PREDICT and CancerMath. All tools consider age and tumor characteristics; 2 tools differentiate between cancer death and death from other causes but use US data and are outdated. Adjuvant! has shown to improve SDM and to change treatment decisions in a randomized controlled trial. Limitations of the identified tools include lack of variables as comorbidity, Her2 status or mode of cancer detection. No tools using German data could be identified; PREDICT uses European data. Conclusion: All tools have relevant limitations. A prognostication tool for individualized risk communication is not available for women with early breast cancer in Germany but is urgently needed. Otherwise informed shared decision making as recommended in guidelines cannot be realized.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/373/CN-01139373/frame.html

Record #75 of 90
ID: CN-01160494
AU: Schapira MM
AU: Hubbard R
AU: Seitz H
AU: Conant E
AU: Schnall M
AU: Capella J
AU: Harrington T
AU: Inge CA
AU: Armstrong K
TI: A randomized controlled trial of a risk based mammography screening decision aid for women 39-48 years of age.
SO: Journal of general internal medicine
YR: 2016
VL: 31
NO: 2 SUPPL. 1
PG: S105
XR: EMBASE 72288168
PT: Journal: Conference Abstract
KY: *human; *risk; *randomized controlled trial; *society; *mammography; *screening; *female; *internal medicine; follow up; breast cancer; decision making; control group; patient worry; hospital; informed consent; randomization; cancer screening; neoplasm; gynecology; statistical significance; obstetrics; general practice; personal value; bivariate analysis; primary medical care; cancer risk; risk assessment; patient; clinical practice; procedures
AB: BACKGROUND: Guidelines recommend that women in their 40's consider individual risk and personal values in deciding the age at which to begin breast cancer screening. However, it is unknown whether a decision aid (DA) that includes tailored risk information for younger women will increase the quality of decision making and impact the age at which women choose to start mammography screening. METHODS: We conducted a RCT in 2014-2015 to evaluate a web based decision aid (DA) delivered within a clinical practice network compared to usual care on knowledge, decisional conflict, and mammography intentions. Women were eligible if aged 39 to 48, enrolled in a participating primary care clinics (family practice, obstetrics and gynecology, and internal medicine), and had not had a previous mammogram. Recruitment took place in-clinic directly prior to the visit with randomization using concealed assignments occurring after obtainment of informed consent. A follow-up survey was conducted at 6 weeks. The DA tool was self-navigated by the patient, included risk estimates based on the NCI Breast Cancer Risk Assessment Tool, comparative risk information, value elicitation, and coaching to encourage shared decision making. Bivariate analysis was conducted to compare 3 pre-specified primary outcomes between groups; knowledge as measured on a 5-item scale (0-low to 5-high), decisional conflict as measured by the 16 item Decision Conflict Scale (DCS), and intended number of years before having a first mammogram. A p-value of 0.017 was considered significant. Exploratory analyses were conducted on outcomes of DC subdomains (Uncertainty, Informed, Values, Support, Effective Decision Making), anticipated regret, and breast cancer worry. RESULTS: There were 204 participants enrolled in the study; DA group (102) and control group (102) with 54.9 % (n = 112) completing the follow-up survey. The median age at the time of the follow-up survey was 40.1 years (range 39-49), 48 % were white, and 41 % were black. Ninety-one percent (91 %, n = 49) of women in the intervention group who completed the follow-up survey also completed the DA. At follow-up, knowledge (range 0-5) was greater in the DA vs. Control group (mean; difference, 95 %CI). (3.07 vs. 2.52, Diff: 0.57, 95 % CI: 0.14 to 0.98). A trend towards lower DCS scores was found in the DAvs. Control group (1.99 vs. 2.29, Diff: -0.30, 95 % CI: -0.63 to 0.38). There was no difference between groups in the intended number of years before having a first mammogram (2.6 vs. 1.6, Diff: 1.0, 95 %CI: -0.29 to 2.31). In exploratory analyses, women in the DA group trended towards decreased DCS scores in the Values domain (2.08 vs. 2.43, Diff: -0.36, 95 %CI: -0.73 to 0.01) and Support domain (1.83 vs. 2.13, Diff:-0.30, 95 %CI: -0.62 to 0.03). There was no difference in the other DCS subdomains. There was no difference between groups in anticipated regret (7 point scale from 1-low to 7-high) of not having a mammogram in your 40's and having cancer detected at a later date (5.45 vs. 5.70, Diff: -0.25, 95 %CI: -0.97 to 0.46) or having a mammogram in your 40's and facing unnecessary follow up tests or procedures: (3.47 vs. 3.28, Diff: 0.19, 95 %CI: -0.55 to 0.93). Breast cancer worry (1-low to 12-high) did not differ between groups (5.42 vs. 5.07, Diff: 0.36, 95 %CI: -0.36 to 1.07). CONCLUSIONS: A web based DA tailored to individualized risk and delivered in a practice setting increased knowledge and trended towards a decrease in decisional conflict when compared to a control of usual care. This study supports the use of a risk based DA to improve the quality of decision making regarding mammography initiation among younger women.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/494/CN-01160494/frame.html

Record #76 of 90
ID: CN-00780173
AU: Atkinson NL
AU: Massett HA
AU: Mylks C
AU: McCormack LA
AU: Kish-Doto J
AU: Hesse BW
AU: Wang MQ
TI: Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design
SO: Journal of the american medical informatics association : JAMIA
YR: 2011
VL: 18
NO: 1
PG: 24-31
PM: PUBMED 21169619
PT: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
KY: Breast Neoplasms [therapy];Clinical Trials as Topic;Consumer Health Information;Health Services Research [methods];Internet;Patient Preference;Patient Satisfaction;Patient Selection;Program Development;Single-Blind Method;United States;User-Computer Interface;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1136/jamia.2010.006122
AB: DESIGN: Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order.MEASUREMENTS: The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better.RESULTS: Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions.CONCLUSION: By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy.OBJECTIVE: Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/173/CN-00780173/frame.html

Record #77 of 90
ID: CN-01172272
AU: Hahlweg P
AU: Witzel I
AU: Muller V
AU: Elwyn G
AU: Durand M-A
AU: Harter M
AU: Scholl I
TI: Evaluation of option grids to support shared decision-making in breast cancer treatment.
SO: Oncology Research and Treatment. Conference: 32. Deutscher Krebskongress, DKK 2016 Berlin Germany. Conference Start: 20160224 Conference End: 20160227. Conference Publication: (var.pagings)
YR: 2016
VL: 39
PG: 46
XR: EMBASE 72212436
PT: Journal: Conference Abstract
KY: *breast cancer; *cancer therapy; *decision making; human; German (citizen); patient; physician; Germany; interview; health care organization; adaptation; participant observation; information processing; cancer patient; oncology
DOI: 10.1159/000444354
AB: Background: Shared decision-making (SDM) is important in oncology, where many preference-sensitive treatment options exist. Many cancer patients wish active engagement in treatment decision-making. Despite evidence, SDM is not widely implemented in routine practice. Option Grids are short decision aids that help patients and physicians to compare treatment options. So far Option Grids are not available in German. The aims of this study are to translate and adapt two Grids on breast cancer treatment, to evaluate their acceptance and feasibility in routine care, and to assess needs for further Grids. Method: We have designed a two-phased study: 1) Translation of both Option Grids into German, comparison to German clinical standards, testing of patients' understanding via cognitive interviews. 2) Pilot testing including focus groups with patients and clinicians to assess acceptability, followed by real world testing in routine breast cancer care using participant observation. Results: First results show that physicians and patients valued the idea of Option Grids. However, several cycles of adaptation were found to be necessary in order to reach adequate acceptance. In addition, the feasibility of using Option Grids in Germany was questioned by several physicians. They expressed doubt if Option Grids can be used in current health care structures and if the options in the translated Option Grids are relevant in Germany. Final results, including pilot testing data, will be presented during the conference. Discussion: This study provided a German version of two Option Grids for breast cancer treatment to be used in Germany for the first time as well as an assessment of their acceptability and feasibility in routine clinical settings.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/272/CN-01172272/frame.html

Record #78 of 90
ID: CN-00733146
AU: Sanguinetti A
AU: Rosato L
AU: Cirocchi R
AU: Barberini F
AU: Pezzolla A
AU: Cavallaro G
AU: Parmeggiani D
AU: Ruggiero R
AU: Docimo G
AU: Procaccini E
AU: Santoriello A
AU: Rulli A
AU: Gubitosi A
AU: Canonico S
AU: Taffurelli M
AU: Sciannameo F
AU: Barbarisi A
AU: Docimo L
AU: Agresti M
AU: Toma G
AU: Noya G
AU: Parmeggiani U
AU: Avenia N
TI: Antibiotic prophylaxis in breast surgery. Preliminary resuls of a multicenter randomized study on 1400 cases
SO: Annali italiani di chirurgia
YR: 2009
VL: 80
NO: 4
PG: 275-279
PM: PUBMED 19967885
PT: Comparative Study; English Abstract; Journal Article; Multicenter Study; Randomized Controlled Trial
KY: Adolescent;Amoxicillin [administration & dosage] [therapeutic use];Anti-Bacterial Agents [administration & dosage] [therapeutic use];Antibiotic Prophylaxis;Breast Diseases [surgery];Breast Neoplasms [surgery];Cefazolin [administration & dosage] [therapeutic use];Clavulanic Acid [administration & dosage] [therapeutic use];Data Interpretation, Statistical;Mastectomy, Radical;Mastectomy, Segmental;Odds Ratio;Patient Selection;Surgical Wound Infection [drug therapy] [prevention & control];Treatment Outcome;Adult[checkword];Aged[checkword];Aged, 80 and over[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-WOUNDS
AB: CONCLUSIONThis study is only a preliminary RCT to be followed by a study which should be enrolled more patients in order to get the results as statistically significant.UNLABELLEDBreast surgery is classified among the procedures performed in clean surgery and is associated with a low incidence of wound infection (3-15%). The objective of this study was to evaluate the advantages antibiotic prophylaxis in patients undergoing breast surgery. A multicenter randomized controlled study was performed between January 2008 and November 2008. One thousand four hundred patients were enrolled in prospective randomized study; surgical wound infection was found in 41 patients (2.93%). In our RCT we have shown that in breast surgery antibiotic prophylaxis does not present significant advantages in patients with potential risk of infection (17 patients, 2.42%, subjected to antibiotic prophylaxis vs 24 patients, 3.43%, without antibiotic prophylaxis) (P = 0.27). In patients with drainage there is a significant minor incidence of wound infections in patients receiving antibiotic prophylaxis (5 patients, 0.92%, subjected to antibiotic prophylaxis vs 14 patients, 3.09%, without antibiotic prophylaxis) (P = 0.02).
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/146/CN-00733146/frame.html

Record #79 of 90
ID: CN-00065814
AU: Cuzick J
TI: Overview of adjuvant radiotherapy for breast cancer
SO: Recent results in cancer research
YR: 1989
VL: 115
PG: 220-225
PM: PUBMED 2696036
PT: Clinical Trial; Journal Article; Randomized Controlled Trial
KY: Breast Neoplasms [mortality] [radiotherapy] [surgery];Combined Modality Therapy;Data Collection [standards];Data Interpretation, Statistical;Mastectomy;Meta-Analysis as Topic;Randomized Controlled Trials as Topic;Survival Rate;Humans[checkword]
CC: SR-CANCER
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/814/CN-00065814/frame.html

Record #80 of 90
ID: CN-01023470
AU: Xiao T
AU: Crew KD
AU: Sivasubramanian PS
AU: Aguirre AN
AU: Smalletz CK
AU: Kukafka R
TI: Development of a patient-centered decision aid to improve accuracy of breast cancer risk perception.
SO: Cancer prevention research (Philadelphia, Pa.)
YR: 2013
VL: 6
NO: 11 SUPPL. 1
XR: EMBASE 71670373
PT: Journal: Conference Abstract
KY: *human; *breast cancer; *cancer risk; *cancer prevention; *patient; risk; female; lifespan; model; information processing; risk factor; exposure; United States; chemoprophylaxis; Internet; population; questionnaire; risk assessment; prevention; speech; genetic screening; narrative; feedback system; family history; Hispanic; Student t test; statistics; Likert scale; community; counseling; randomized controlled trial; primary medical care; McNemar test
AB: Background: Breast cancer risk assessment and interventions for prevention, such as chemoprevention, are underutilized in the U.S. Reasons for low uptake include inability to routinely screen for high-risk women in the primary care setting, inadequate time for counseling, and insufficient knowledge about risk-reducing strategies. We developed an initial prototype of a web-based decision aid (DA), RealRisks, which incorporates experience-based dynamic interfaces to communicate risk aimed at reducing inaccurate risk perceptions, particularly in low-numerate populations. Methods: RealRisks is a patient DA that models patient-provider dialogue with modules on breast cancer risk, genetic testing, and chemoprevention. Embedded within the narrative are 2 games of experience-based risk interfaces, demonstrating average 5-year and lifetime breast cancer risk. Both games ask players to sample from a pictograph of 100 clickable women to better learn the meaning of a pre-set probability (i.e., 12 out of 100 women or 12%). We conducted four focus groups of 7-9 English-speaking women over the age of 18, recruited from the local community in Upper Manhattan in New York City. These recorded sessions lasted about 90 minutes and involved use of RealRisks on a laptop, questionnaire completion before and after interacting with the DA, and a semi-structured group discussion. Questionnaires included information about demographics, numeracy, internet access, breast cancer risk factors, perceived breast cancer risk, and evaluation of RealRisks on a 7-point Likert scale. Descriptive statistics were generated to document baseline characteristics and frequencies of positive and negative attitudes about RealRisks. Paired t-test and McNemar's test were used to compare within-individual changes in accuracy of perceived breast cancer risk. During the group discussion, verbal responses were condensed into themes using a qualitative approach. Results: From May to June 2013, 34 women were enrolled. Median age was 53.5 (range, 35-75); 85% were either black or Hispanic; 41% met criteria for low numeracy; and 88% had internet access. After removing 3 women with a history of breast cancer, 3 (9.7%) met high-risk criteria for breast cancer according to the Gail model (>1.67% 5-year risk) and mean 5-year and lifetime breast cancer risk were 1.11% (+0.77) and 7.46% (+2.87), respectively. After interacting with RealRisks, the difference in perceived vs. actual breast cancer risk according to the Gail model significantly improved for 5-year risk (p=0.008), but not lifetime risk (p=0.20). Before exposure to RealRisks, 52% had accurate breast cancer risk perceptions (defined as within +5% of actual lifetime risk according to the Gail model) compared to 70% after RealRisks (p=0.10). In particular, 4 out of 5 women who overestimated their lifetime breast cancer risk by >30% had accurate risk perceptions after exposure to RealRisks. We found a significant association between numeracy and accuracy of risk perception after interacting with RealRisks (p=0.05). Over 85% of the participants thought RealRisks was useful, easy to use, increased their knowledge about breast cancer and understanding of breast cancer risk factors. From the focus group discussions, we found that knowledge about breast cancer risk factors, apart from family history, was limited. Participants were interested in receiving a personalized breast cancer risk assessment and found the interactive games engaging. Discussion: In a multi-ethnic low-numerate population, we demonstrated a significant improvement in accuracy of perceived breast cancer risk after exposure to RealRisks. Based upon feedback from our focus groups, we were able to identify information needed to fully represent the important issues of breast cancer risk to further develop our prototype for testing in a randomized controlled trial.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/470/CN-01023470/frame.html

Record #81 of 90
ID: CN-00680448
AU: Panzarella T
AU: Meakin JW
TI: Analysis of cause-specific failure endpoints using simple proportions: an example from a randomized controlled clinical trial in early breast cancer
SO: International journal of radiation oncology, biology, physics
YR: 1998
VL: 41
NO: 5
PG: 1093-1097
PM: PUBMED 9719120
PT: Clinical Trial; Journal Article; Randomized Controlled Trial
KY: Antineoplastic Agents, Hormonal [therapeutic use];Breast Neoplasms [drug therapy] [mortality] [pathology] [radiotherapy] [surgery];Combined Modality Therapy;Data Interpretation, Statistical;Prednisone [therapeutic use];Radiotherapy Dosage;Retrospective Studies;Time Factors;Treatment Failure;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
CC: SR-BREASTCA: SR-CANCER
AB: METHODS AND MATERIALSIn the comparison of treatment groups, time to first failure (in any site) was analyzed first, followed by an analysis of the pattern of first failure, preferably at the latest complete follow-up time common to each group.RESULTSA retrospective analysis of time to contralateral breast cancer in 777 early breast cancer patients was undertaken. Patients previously treated by mastectomy plus radiation therapy to the chest wall and regional nodal areas were randomized to receive further radiation and prednisone (R+P), radiation alone (R), or no further treatment (NT). Those randomized to R+P had a statistically significantly delayed time to first failure compared to the group randomized to NT (p = 0.0008). Patients randomized to R also experienced a delayed time to first failure compared to NT, but the difference was not statistically significant (p = 0.14). At 14 years from the date of surgery (the latest common complete follow-up time) the distribution of first failures was statistically significantly different between R+P and NT (p = 0.005), but not between R and NT (p = 0.09). The contralateral breast cancer first failure rate at 14 years from surgery was 7.2% for NT, 4.6% for R, and 3.7% for R+P. The corresponding Kaplan-Meier estimates were 13.2%, 8.2%, and 5.4%, respectively.CONCLUSIONAnalyzing cause-specific failure data using methods developed for survival endpoints is problematic. We encourage the use of the two-step analysis strategy described when, as in the example presented, competing causes of failure are not likely to be statistically independent, and when a treatment comparison at a single time-point is clinically relevant and feasible; that is, all patients have complete follow-up to this point.PURPOSETo describe a statistically valid method for analyzing cause-specific failure data based on simple proportions, that is easy to understand and apply, and outline under what conditions its implementation is well-suited.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/448/CN-00680448/frame.html

Record #82 of 90
ID: CN-00789609
AU: Schwartz MD
AU: Valdimarsdottir HB
AU: DeMarco TA
AU: Peshkin BN
AU: Lawrence W
AU: Rispoli J
AU: Brown K
AU: Isaacs C
AU: O'Neill S
AU: Shelby R
AU: Grumet SC
AU: McGovern MM
AU: Garnett S
AU: Bremer H
AU: Leaman S
AU: O'Mara K
AU: Kelleher S
AU: Komaridis K
TI: Randomized trial of a decision aid for BRCAL/BRCA2 mutation carriers: impact on measures of decision making and satisfaction
SO: Health psychology
YR: 2009
VL: 28
NO: 1
PG: 11-19
XR: EMBASE 2009044717
PT: Journal: Article
KY: *Decision Making; *Mastectomy; *Mutation; *Risk; *Satisfaction; Arm; Breast Cancer; Cancer Risk; Computer; Decision Support System; Family History; Female; Genetic Counseling; Genetic Screening; Randomization; Randomized Controlled Trial; Risk Management
AB: Objective: Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, the authors developed a computer-based interactive decision aid that was tested against usual care in a randomized controlled trial. Design: After the completion of genetic counseling, 214 female (aged 21-75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N = 114) or Usual Care plus Decision Aid (DA; N = 100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM DA to view at home. Main Outcome Measures: The authors measured final management decision, decisional conflict, decisional satisfaction, and receipt of risk reducing mastectomy at 1-, 6-, and 12-months postrandomization. Results: Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR = 3.09, 95% CI = 1.62, 5.90; p <.001), decreased decisional conflict (B = -.46, z = -3.1, p <.002), and increased satisfaction (B =.27, z = 3.1, p =.002) compared to UC. Among carriers who had already made a management decision by the time of randomization, the DA had no benefit relative to UC. Conclusion: These results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support. 2009 American Psychological Association.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/609/CN-00789609/frame.html

Record #83 of 90
ID: CN-01016022
AU: Belkora JK
AU: Hutton DW
AU: Moore DH
AU: Siminoff LA
TI: Does use of the adjuvant! Model influence use of adjuvant therapy through better risk communication?.
SO: JNCCN Journal of the National Comprehensive Cancer Network
YR: 2011
VL: 9
NO: 7
PG: 707-12
XR: EMBASE 2011375444
PT: Journal: Review
KY: *breast cancer; cancer adjuvant therapy; cancer risk; cancer survival; decision making; female; Fisher exact test; human; major clinical study; patient education; patient preference; review; *risk assessment
AB: Adjuvant! is a model that provides recurrence and mortality risk predictions for patients with breast cancer considering adjuvant therapies. Although low-risk patients who saw Adjuvant! chose adjuvant therapy less frequently, whether this was because of educational or other aspects of the decision aid is unknown. The authors explored whether Adjuvant! affects choice of therapy through increased patient knowledge. A subset of data were analyzed from a cluster randomized trial in which oncology practices in 2 major United States cities were randomly assigned to use either Adjuvant! or an informational pamphlet to educate patients. Of 405 patients, 48 were low-risk, with 28 assigned to the decision aid and 20 to the pamphlet. Among the low-risk patients, using frequency tables and Fisher exact tests, the authors explored whether Adjuvant! was associated with more accurate patient estimates of survival; whether accuracy was associated with treatment choice; and whether, after controlling for accuracy, any remaining association was seen between Adjuvant! and treatment choice. Adjuvant! was associated with more accurate estimates of baseline prognosis compared with the pamphlet (57% vs. 25%; P = .04). Patients who had more accurate estimates of baseline prognosis were less likely to choose adjuvant therapy (62% vs. 89%; P = .04). After controlling for accuracy, no statistically significant association was found between the use of Adjuvant! and adjuvant therapy (P = .59 and P = .11 for inaccurate and accurate patients, respectively). Adjuvant! seems to influence patient choice through educational rather than other means of persuasion. However, many patients held inaccurate risk perceptions after viewing Adjuvant!. JNCCN-Journal of the National Comprehensive Cancer Network.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/022/CN-01016022/frame.html

Record #84 of 90
ID: CN-01062205
AU: Garvelink M
AU: Ter Kuile M
AU: Stiggelbout A
AU: Vries M
TI: Use of a values clarification exercise about fertility preservation leads to more clarity about values and more knowledge in healthy participants.
SO: Psycho-oncology
YR: 2013
VL: 22
PG: 354-5
XR: EMBASE 71356971
PT: Journal: Conference Abstract
KY: *oncology; *human; *fertility preservation; *society; *exercise; monitoring; personality; information seeking; secondary analysis; breast cancer; decision making; neurosis; population; cancer patient; female
DOI: 10.10002/pon.3394
AB: BACKGROUND: To improve information provision about fertility preservation (FP) and support informed decision making for young breast cancer patients, a decision aid (DA) with explicit values clarification exercise (VCE) was developed. We found that healthy respondents who used the VCE reported less decisional conflict compared to those who did not, but few respondents had used the VCE. The current experiment studies the relation between personality, DA-use and decisional conflict with or without referral to the VCE. METHOD: Healthy participants (n = 193) were randomized between information only(VCE-), information+ VCE without referral to the VCE (VCE+), or information+VCE with referral to the VCE (VCE++) and were asked to make a hypothetical decision regarding FP. Measures were personality traits (neuroticism, conscientiousness, monitoring, blunting), DA-use (time spent, pages viewed, VCEuse), decisional conflict (including subscales), and knowledge. RESULTS: More women in VCE++ used the VCE (85%) compared to VCE+ (57%; OR = 4.47, p < 0.001). There were no differences in decisional conflict or knowledge between conditions (-/++), mean absolute knowledge between baseline and post-DA was 40%. Secondary analyses revealed that blunting was univariately associated with fewer pages viewed (B = -0.734 SE = 0.23, p < 0.01), monitoring with more time spent on the DA (B = 21.01 SE = 9.75 p < 0.05). Within VCE+/++, VCE-use was related to more values clarity (M = 37.1(SD = 14.3); M = 31.1 (SD = 14.7) p < 0.05). There was an interaction between group x conscientiousness and VCE-use (OR = 4.3 p = 0.038); conscientiousness was positively related to VCE-use in VCE++, and not related to VCE-use in VCE+. CONCLUSIONS: Our DA leads to increased knowledge in a healthy population making a hypothetical decision. There were no differences with regard to knowledge or decisional conflict. Secondary analyses suggest a relation between VCE-use and values clarity, and between conscientiousness and VCE-use in the referred group. The extent of use of the total DA was related to monitoring and blunting information seeking styles. Therefore, personality (with regard to information seeking) might be an important factor explaining the extent to which a DA is used, and the effectiveness of DAs .
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/205/CN-01062205/frame.html

Record #85 of 90
ID: CN-01006284
TI: Singapore Health and Biomedical Congress, SHBC 2013.
SO: Annals of the Academy of Medicine Singapore. (S327 pages)
YR: 2013
VL: 42
PG: S1
XR: EMBASE 75001076
PT: Journal: Conference Review
KY: *health; *Singapore; human; patient; hospital; aged; diabetes mellitus; primary medical care; health care; prevalence; schizophrenia; hospital patient; hospital readmission; hearing impairment; multiple myeloma; health care personnel; drug therapy; medical audit; Asian; gene; skin; mental patient; learning; tertiary health care; outpatient department; podiatry; medical education; mortality; osteoporosis; medication compliance; computer; outpatient; total knee replacement; femoral nerve; nerve block; follow up; serum; diagnosis; pilot study; hypertension; community; machine; pharmacist; hearing aid; smoking cessation; dermatology; heart failure; physiotherapy; adult; intensive care unit; morphology; bariatric surgery; phototherapy; palliative therapy; chronic kidney disease; nurse; pharmacy; computer assisted tomography; neoplasm; cognition; risk; non insulin dependent diabetes mellitus; mental health; child; computer program; diabetic macular edema; obesity; acute heart infarction; influenza; biomedicine; vaccination; lifelong learning; hypoglycemia; radiotherapy; day hospital; screening; nutrition; population; anxiety; monitoring; childhood; mass screening; anesthesia; cognitive therapy; screening test; aphasia; community sample; interview; decision support system; factorial analysis; cardiovascular mortality; hydrogel; hip; male; patient satisfaction; femur neck fracture; infarction; visual acuity; registered nurse; protein intake; Japan; China; quality of life; distress syndrome; caregiver; anemia; hospital physician; education; diet restriction; nursing assistant; mental hospital; advanced practice nurse; ward; rehabilitation; dietary intake; shoulder; drug interaction; university; hip fracture; thorax radiography; patient care; grounded theory; operating room; violence; grain; electroencephalography; autism; contamination; bone scintiscanning; employment; mobilization; facial nerve paralysis; disruptive behavior; functional disease; body mass; teaching; intracameral drug administration; dementia; spiritual care; apheresis; infection; pain; religion; optical coherence tomography; stomach cancer; physiotherapist; ischemic cardiomyopathy; multicenter study; kidney failure; simulation; biliary stent; traumatic brain injury; retinal thickness; amyloidosis; hyponatremia; hospice; leg; nuclear magnetic resonance imaging; influenza vaccination; rehabilitation center; ethnicity; endophthalmitis; sleep; patient controlled analgesia; myeloma; vitiligo; sarcopenia; gait; microbiome; hospital discharge; intestine; gout; injection; psychosis; randomized controlled trial; atopic dermatitis; longitudinal study; genome; retrospective study; sleep disordered breathing; cholesterol blood level; enzymic biosensor; dialysis; NK T cell lymphoma; fracture; gastrectomy; extracellular matrix; cancer patient; zebra fish; functional genomics; observational study; data base; fasciitis; neck; eukaryotic flagellum; mycosis; electrostimulation; wound healing; breast cancer; bipolar disorder; hearing; questionnaire; self concept; burnout; stereotypy; occupation; health science; nursing education; administrative personnel; prevention; literature; metastasis; cardiology; orbit; haploinsufficiency; circulating tumor cell; gene mutation; tobacco; cognitive defect; in vitro study; planning; medication therapy management; nursing home; mental disease; photography; thrombocyte; therapy; professional practice; workplace; book; thrombocyte count; packaging; Escherichia coli; epidemiology; tuberculosis; model; chikungunya; summer; winter; perfusion; corpus callosum; diseases; pseudoexfoliation; eye; cornea thickness; keratoconus; electroencephalogram; electrocardiogram; plastic; antibiotic agent; vitamin D; microRNA; vasculotropin; fibrinogen; acetylsalicylic acid; lipid; alcohol; sex hormone; brain derived neurotrophic factor; collagen; leucine rich repeat kinase 2; tigecycline
AB: The proceedings contain 327 papers. The special focus in this conference is on Health and Biomedicine. The topics include: Reducing the rate of postoperative endophthalmitis over 11 years-results of a new intervention using intracameral antibiotics; corpus callosum morphology in first episode and chronic schizophrenia; differences in late cardiovascular mortality following acute myocardial infarction among three major Asian ethnicities; exploring relationship of retinal thickness on optical coherence tomography and visual acuity in patients with diabetic macular edema; medication reconciliation in outpatient hospital clinics; utilising discharge planning tools in an inpatient psychiatric rehabilitation services to promote positive clinical outcomes; seven-point subjective global assessment is more time sensitive than conventional subjective global assessment in detecting nutritional changes; Singapore hospice nurses perspectives about spirituality and spiritual care; enhanced infarct stabilisation and cardiac repair with an injectable PEGylated-fibrinogen hydrogel carrying vascular endothelial growth factor (VEGF); identification of tumour suppressive MicroRNAs in multiple myeloma by pharmacologic unmasking; use of a novel stereographic projection software to calculate precise area of peripheral non-perfusion and its correlation with manual grading; a protocol to reduce inter-reviewer variability in computed tomography measurement of orbital floor fractures; impact of genome wide supported psychosis susceptibility NRGN gene on thalamocortical morphology in schizophrenia; improved outcome of myeloma patients in a tertiary hospital; femoral neck fractures-factors affecting ambulatory status in elderly patients more than 65 years old who underwent hip hemiarthroplsty; exploratory factor analysis of the Zarit burden interview in a multi-ethnic Asian community sample; prevalence, awareness, treatment and control of hypertension among Singapore elderly residential population; predictive factors of unscheduled 15-day hospital readmissions; lost in transition-newly qualified registered nurses and their transition to practice journey; national healthcare group clinical educators reflection on web2.0's application in enhancing teaching and lifelong learning in medical education; determinants of clarification studies in medical education research; hypoglycemia management of patients with type 2 diabetes in primary care setting; photograph-assisted dietary review amongst type 2 diabetics in primary care; exploring the feasibility of advanced care planning in persons with early cognitive impairment; roles of miR-186 in circulating tumour cells (CTCs)-mediated metastasis in breast cancer; characterisation of the biological and clinical relevance of RUNX genes in natural killer T-cell lymphoma; a randomised controlled trial comparing single-injection and continuous femoral nerve blocks with patient-controlled analgesia; magnetic resonance imaging (MRI) changes in lower limbs in transition to frailty; prevalence of dilutional hyponatraemia in inpatients and outpatients in Singapore; a prospective randomised study on the patency period of the plastic anti-reflux biliary stent; an academic-practice collaboration through simulation learning; a multicentre study of physiotherapists' knowledge and perceptions in palliative care; post discharge pain experiences following total knee arthroplasty; characteristics of subjective QOL of elderly people with dementia in china and Japan; audit of readmissions to a palliative care unit in a tertiary hospital; factors affecting psychological distress in informal caregivers of Singapore elderly; prevalence of anaemia in patients on aspirin medication in a primary care setting; patient satisfaction with pharmacist-managed hypertension-diabetes-lipids clinic and its relation to medication adherence and beliefs about medication; anthropometric measures and cognition in the Singapore elderly; clinical decision support for high-priority drug-drug interactions; a normative study on the national university health system aphasia screening test; a pilot study on the integration of a cognitive-behavioral therapy-based computer game in the clinical treatment of childhood anxiety; barriers of whole-grain intake among healthcare workers in national healthcare group polyclinics; a novel approach to lead screening; effects of computed tomography contrast on bone scans; prevalence and predictors of employment among the Singaporean elderly; evaluating the impact of inpatient accelerated palliative radiation therapy programme in reducing inpatient hospitalisation; socio-demographic correlates of positive mental health; unravelling the relationship between obesity, schizophrenia and cognition; relationship between measures of mental health and functional impairment in primary care; body mass index of elderly persons in Singapore; improving the influenza and pneumococcal vaccination rate of eligible patients with chronic heart failure; reducing near misses from packing errors in inpatient pharmacy; pharmacy-led smoking cessation clinic in dermatology; investigation of high platelet count in random platelet unit and its viability; public attitudes towards mentally-ill persons in Singapore; revisiting the association between parental bonding and risk for psychopathology; pharmacist reviews and outcomes in nursing homes in Singapore; evaluation of the inpatient smoking cessation programme in tan Tock Seng hospital; community forums are effective in improving osteoporosis knowledge; profile of patients referred for podiatry services in primary care; novel use of tigecycline for multiple myeloma in vitro-alternative non-mitochondrial pathways; linking human leucine-rich repeat kinase 2 (LRRK2) gene mutation to cancer development; haploinsufficiency of TP53 in multiple myeloma; bioactive and conductive collagen scaffold for wound healing augmented by electrical stimulation; systematic discovery of novel cilia and ciliopathy genes through functional genomics in the zebrafish; extracellular matrix-based biohybrid skin substitutes; enzyme sensor system for determination of total cholesterol in human serum; intestinal microbial study of gout patients; differences in gut microbiome between schizophrenic patients and healthy individuals; changes in gait associated with sarcopenia; noncultured cellular grafting for vitiligo-a three-year follow-up study; bariatric surgery and its impact on sleep; clinico-epidemiological profile of moderate to severe paediatric atopic dermatitis; influenza vaccination of healthcare workers; a snapshot of audits in the phototherapy unit; a naturalistic longitudinal study in healthy children; retrospective study on autoimmune blistering disease in paediatric patients; association between CHA65S2 score and obstructive sleep apnoea; primary localised cutaneous amyloidosis; high STOP-BANG scores herald adverse perioperative outcomes; neurobehavioral outcomes after traumatic brain injury; extended outcomes by dialysis modality selection in incident patients with end-stage renal disease and ischaemic cardiomyopathy; laparoscopic gastrectomies in gastric cancer patients; survey on factors influencing medication adherence in psychiatric patients; serum brain-derived neurotrophic factor and metabolic indices in patients with schizophrenia; outcomes of non-Tbitrauma patients in a surgical intensive care unit; evaluation of patients screened for MERS-CoV infection at tan Tock Seng hospital, Singapore; thinking twice before using the LMA for obese and older patients-a prospective observational study; comparison study between two apheresis machines; diabetes knowledge in older adults with type 2 diabetes in Singapore; establishing an intensive care unit database; necrotising fasciitis of the head and neck; diabetic chronic kidney disease patients should increase protein intake; the skin-endocrine axis in the management of dermatology patients; dematiaceous mycoses of the skin in Singapore from 2003 to 2010; profile of hearing aids users in Singapore; factors that affect the degree of hearing loss at presentation and hearing aid usage; cross diagnostic comparisons of quality of life between schizophrenia and bipolar disorder patients; value of hearing questionnaire in predicting hearing impairment; utility of self-perception of hearing loss questions in predicting hearing impairment; burnout, challenges and supportive factors in hospital doctors; exploring stereotypes in healthcare professions; health sciences virtual hospital game as a learning tool in nursing education; application of the RIME framework for education administrators' competencies; bed exit alarm as a novel tool for fall prevention; when prolonged preoperative fasting is a myth; time-motion study for nursing aides activities in a psychiatric hospital; impact of an advanced practice nurse-led heart failure clinic in a secondary hospital in Singapore; managing individuals with diabetes using the diabetes ambulatory stabilisation services (DASS); streamlining process flow for maintenance of 12-lead ECG machine in a cardiology ward; factors of rehabilitation outcomes in primary care physiotherapy; dietary intake of wholegrains of healthcare workers in national healthcare group polyclinics; management of patients with diabetes in two primary care podiatry clinics; preliminary evaluation of shoulder conditions in primary care physiotherapy; prevalence of alcohol problems among elderly in Singapore; prevalence and predictors of tobacco use in elderly Singaporeans; mortality predictors for operative hip fracture patients; a risk index to predict 30 days emergency hospital readmission; compliance of preoperative chest X-rays in anaesthesia clinic; predictors of mortality in patients with chronic kidney disease; continuity of care issues in the Singapore health system; factors influencing patients adherence to follow-up post bariatric surgery; a snapshot of audits in the phototherapy unit; health screening perceptions in Singapore-a grounded theory study; interactive dashboard for monitoring operating theatre operational efficiency; reducing violence through the use of structured therapies; early home visits by care coordinators help to reduce hospital readmission rate; evaluation of a workplace nutrition programme at a hospital; a review of the use of electroencephalography in autism spectrum disorder in the past decade; an alternate plastic packaging to reduce threat of e coli contamination; spatial epidemiology of tuberculosis in Singapore; development of a polarised cellular model for Chikungunya virus infection; summer-winter differences in total vitamin D concentrations in Singapore; effect of femoral nerve block on ambulation following total knee arthroplasty; development of a computer-based objective grading system for facial paralysis; a preliminary finding of EEG differences of children with disruptive behaviour disorders in Singapore; sex hormone concentrations in Singaporean men; deciding where to allocate diabetic educational resources; pseudoexfoliation syndrome at a Singapore eye clinic; corneal thickness in Asian keratoconus patients; reasons influencing non-adherence to medications in psychiatric patients; pilot study on nurses' perceptions towards different aspects of learning; oral conditions among dependent community-dwelling elderly persons; knowledge of osteoporosis among Singapore adults in national healthcare group polyclinics (NHGP) settings and knowledge adequacy of diagnosis and treatment plans of elderly patients on discharge from tertiary hospital.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/284/CN-01006284/frame.html

Record #86 of 90
ID: CN-01019774
AU: Watts KJ
AU: Meiser B
AU: Mitchell G
AU: Kirk J
AU: Saunders C
AU: Peate M
AU: Duffy J
AU: Kelly PJ
AU: Gleeson M
AU: Barlow-Stewart K
AU: Rahman B
AU: Friedlander M
AU: Tucker K
AU: Antill Y
AU: Gregory P
AU: Lipton L
AU: McKay L
AU: Senior J
AU: Lobb EA
AU: Crowe P
AU: Matthews A
AU: Neil G
AU: Parasyn A
AU: Thomson D
AU: Zilliacus E
AU: Andrews L
AU: Gale J
AU: Fox J
AU: Harris M
AU: Hart S
AU: Smythe C
AU: White M
AU: Creighton L
AU: Crowe K
AU: D'arcy J
AU: Grieve S
AU: Secomb E
AU: Cicciarelli L
AU: Henderson M
AU: O'Brien J
AU: Poliness C
AU: Hattam A
AU: Susman R
AU: Ung O
AU: Dickson R
AU: Field M
AU: Moore K
AU: Bastick P
AU: Inder S
AU: Lynch J
AU: Schwartz P
AU: Zia R
AU: Mak C
AU: Snook K
AU: Spillane A
AU: Hopper J
AU: Geelhoed L
AU: Bowman M
AU: Cheung D
AU: Edirimanne S
AU: Edwards E
AU: Elder E
AU: French J
AU: Moon D
TI: How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer.
SO: BMC cancer
YR: 2012
VL: 12
XR: EMBASE 2012612638
PT: Journal: Article
KY: anxiety; article; Australia; *breast cancer; cancer radiotherapy; cost effectiveness analysis; depression; distress syndrome; family history; gene mutation; genetic counseling; *genetic screening; health economics; health personnel attitude; mastectomy; multicenter study (topic); ovary cancer; patient decision making; *patient education; questionnaire; randomized controlled trial (topic); salpingooophorectomy; *treatment focused genetic testing; tumor suppressor gene
DOI: 10.1186/1471-2407-12-320
AB: Background: Germline BRCA1 and BRCA2 mutation testing offered shortly after a breast cancer diagnosis to inform women's treatment choices - treatment-focused genetic testing 'TFGT' - has entered clinical practice in specialist centers and is likely to be soon commonplace in acute breast cancer management, especially for younger women. Yet the optimal way to deliver information about TFGT to younger women newly diagnosed with breast cancer is not known, particularly for those who were not suspected of having a hereditary breast cancer syndrome prior to their cancer diagnosis. Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT. This trial aims to examine the impact and efficiency of two models of educating younger women newly diagnosed with breast cancer about genetic testing in order to provide evidence for a safe and effective future clinical pathway for this service.Design/methods: In this non-inferiority randomized controlled trial, 140 women newly diagnosed with breast cancer (aged less than 50 years) are being recruited from nine cancer centers in Australia. Eligible women with either a significant family history of breast and/or ovarian cancer or with other high risk features suggestive of a mutation detection rate of > 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.Discussion: This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.Trial registration: The study is registered with the Australian and New Zealand Clinical Trials Group (Registration no: ACTRN12610000502033). 2012 Watts et al.; licensee BioMed Central Ltd.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/774/CN-01019774/frame.html

Record #87 of 90
ID: CN-00623065
AU: Wilkins EG
AU: Lowery JC
AU: Copeland LA
AU: Goldfarb SL
AU: Wren PA
AU: Janz NK
TI: Impact of an educational video on patient decision making in early breast cancer treatment
SO: Medical decision making
YR: 2006
VL: 26
NO: 6
PG: 589-598
PM: PUBMED 17099197
XR: EMBASE 44728775
PT: Journal: Article
KY: adult; anxiety; article; *breast cancer/su [Surgery]; cancer staging; cancer surgery; *cancer therapy; female; human; major clinical study; male; mastectomy; patient care; *patient decision making; patient satisfaction; statistical significance
CC: HS-UKCC: HS-HANDSRCH
DOI: 10.1177/0272989X06295355
AB: Previous research suggests that patient education programs promoting shared decision making (SDM) may improve patient satisfaction and outcomes, yet controlled clinical trials are lacking. The authors evaluate the impact of an early breast cancer treatment educational video on patients' decisional preferences and behavior. Newly diagnosed stage I/stage II breast cancer patients were assigned to SDM video program or control groups in alternating months. Surveys were administered prior to the provider visit and 1 week following the treatment decision. Variables assessed included autonomy preferences, perceived involvement in care, satisfaction, and treatment choice. There were no significant intervention effects on informational/decisional preferences, anxiety, knowledge, or satisfaction. Although 25% of SDM patients chose mastectomy compared to 14% of controls, this difference was not statistically significant. Eventhough enthusiasm for SDM programs remains high among some patients and providers, this study found only modest benefits.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/065/CN-00623065/frame.html

Record #88 of 90
ID: CN-01089056
AU: Sapienza LG
AU: Aiza AR
AU: Lins LAN
AU: Trigo CC
AU: Fogaroli RC
AU: Maia MAC
TI: A single-blinded RCT of the use of bolus in post mastectomy irradiation in breast cancer.
SO: Radiotherapy and oncology
YR: 2014
VL: 111
PG: S64
XR: EMBASE 71889434
PT: Journal: Conference Abstract
KY: *irradiation; *breast cancer; *European; *society; *radiotherapy; *oncology; *mastectomy; human; patient; radiation dermatitis; informed consent; toxicity; risk; dermatitis; diagnosis; low risk patient; skin ulcer; staging; photon; skin; neoplasm; Fisher exact test; cancer patient; statistical analysis; randomization; follow up; nurse; tissues; clinical study
AB: Purpose/Objective: There is a lack of clinical data about the use of bolus (tissue equivalent material) in post mastectomy irradiation in breast cancer patients treated with tangent photons fields. We designed a trial to evaluate toxicity, clinical impact and economic expenses of different frequencies of use of the bolus (NCT01925651). Materials and Methods: Fifty-four consecutive patients were recruited and are being followed prospectively. The inclusion criteria are breast cancer with histopathological diagnosis, more than 18 years old and no history of previous thoracic irradiation. All patients signed an informed consent form. The patients are categorized in high risk or low risk, based on the extension of the tumor to the skin in clinical and pathological staging. The low risk patients are then randomized to no use of bolus or use of a 0.5cm bolus in alternated day. The high risk ones are randomized to use a 0.5cm bolus daily or in alternated days. The patients are examined weekly to evaluate the grade of radiodermatitis according to Common Terminology Criteria for Adverse Events (CTCAE v4.0), the local care products, and treatment interruptions due to dermatitis. The evaluation was done by a nurse specialized in radiodermitis, without knowledge of patient randomization. for the statistical analysis weused the Fisher exact test. Results: With the accrual of 54 patients (july-november 2013), we present the results of the 29 patients with final follow-up until this interim analysis (november 2013). two patients removed the informed consent, being excluded from the study and not randomized. All patients had at least grade 1 radiodermatitis. Three patients in the no bolus group (3/7) and three patients in alternated bolus group have grade 2 radiodermatitis (p=0.3185). Comparing alternated bolus with daily bolus, no patient in first group developed grade 3 toxicity (0/16), but 66% (4/6) developed G3 radiodermatitis with daily bolus (p=0.0021). The patients with G3 radiodematitis were treated with a hidrocolloid curative and had the skin ulcers resolved in three weeks. No patient interrupted treatment until this analysis. Conclusions: There is a significant increase in G3 radiodermatitis in patients treated with daily 0.5cm bolus (p=0.0021). This translated in more expenses with curatives and patient suffering. No increase of interruption of treatment was detected until this interim analysis. The decision of indicating a higher frequency of bolus should be carefully evaluated due to the lack of evidence of clinical benefit in local control and the increased toxicity to the patient.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/056/CN-01089056/frame.html

Record #89 of 90
ID: CN-00842025
AU: Watts KJ
AU: Meiser B
AU: Mitchell G
AU: Kirk J
AU: Saunders C
AU: Peate M
AU: Duffy J
AU: Kelly PJ
AU: Gleeson M
AU: Barlow-Stewart K
AU: Rahman B
AU: Friedlander M
AU: Tucker K
TI: How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer.
SO: BMC cancer
YR: 2012
VL: 12
PG: 320
PM: PUBMED 22838957
PT: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
KY: Age Factors;Breast Neoplasms [genetics] [psychology] [therapy];Clinical Protocols;Genes, BRCA1;Genes, BRCA2;Genetic Counseling [ethics];Genetic Testing [ethics];Mutation;Female[checkword];Humans[checkword]
DOI: 10.1186/1471-2407-12-320
AB: BACKGROUND: Germline BRCA1 and BRCA2 mutation testing offered shortly after a breast cancer diagnosis to inform women's treatment choices - treatment-focused genetic testing 'TFGT' - has entered clinical practice in specialist centers and is likely to be soon commonplace in acute breast cancer management, especially for younger women. Yet the optimal way to deliver information about TFGT to younger women newly diagnosed with breast cancer is not known, particularly for those who were not suspected of having a hereditary breast cancer syndrome prior to their cancer diagnosis. Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT. This trial aims to examine the impact and efficiency of two models of educating younger women newly diagnosed with breast cancer about genetic testing in order to provide evidence for a safe and effective future clinical pathway for this service.DESIGN/METHODS: In this non-inferiority randomized controlled trial, 140 women newly diagnosed with breast cancer (aged less than 50 years) are being recruited from nine cancer centers in Australia. Eligible women with either a significant family history of breast and/or ovarian cancer or with other high risk features suggestive of a mutation detection rate of > 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.DISCUSSION: This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/025/CN-00842025/frame.html

Record #90 of 90
ID: CN-01179376
AU: Cardoso F
AU: van't Veer LJ
AU: Bogaerts J
AU: Slaets L
AU: Viale G
AU: Delaloge S
AU: Pierga JY
AU: Brain E
AU: Causeret S
AU: DeLorenzi M
AU: Glas AM
AU: Golfinopoulos V
AU: Goulioti T
AU: Knox S
AU: Matos E
AU: Meulemans B
AU: Neijenhuis PA
AU: Nitz U
AU: Passalacqua R
AU: Ravdin P
AU: Rubio IT
AU: Saghatchian M
AU: Smilde TJ
AU: Sotiriou C
AU: Stork L
AU: Straehle C
AU: Thomas G
AU: Thompson AM
AU: Hoeven JM
AU: Vuylsteke P
AU: Bernards R
AU: Tryfonidis K
AU: Rutgers E
AU: Piccart M
TI: 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer
SO: New England journal of medicine
YR: 2016
VL: 375
NO: 8
PG: 717-729
PM: PUBMED 27557300
PT: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
KY: Antineoplastic Agents [therapeutic use];Breast Neoplasms [drug therapy] [genetics] [mortality] [surgery];Chemotherapy, Adjuvant;Disease-Free Survival;Gene Expression;Gene Expression Profiling;Genetic Predisposition to Disease;Genetic Testing;Kaplan-Meier Estimate;Mastectomy;Neoplasm Metastasis [prevention & control];Neoplasm Staging;Oligonucleotide Array Sequence Analysis;Prospective Studies;Risk;Risk Assessment;Adult[checkword];Aged[checkword];Female[checkword];Humans[checkword];Middle Aged[checkword]
DOI: 10.1056/NEJMoa1602253
AB: METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher.RESULTS: A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemotherapy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease.CONCLUSIONS: Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemotherapy. (Funded by the European Commission Sixth Framework Program and others; ClinicalTrials.gov number, NCT00433589; EudraCT number, 2005-002625-31.).BACKGROUND: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy.
US: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/376/CN-01179376/frame.html

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