SONICS: Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy: A Multi-center, Randomized, Wait-List Controlled Trial

Abstract

Four in 10 individuals receiving neurotoxic chemotherapy develop chronic painful CIPN, symptoms which negatively influence physical function and may require the withdrawal of chemotherapy. However, few recommended pharmacological and no effective non-pharmacological treatments for chronic painful CIPN exist.

The purpose of this research was to examine the efficacy of a self-guided online cognitive and behaviorally-based pain management intervention called Proactive Self-Management Program for Effects of Cancer Treatment (PROSPECT) to reduce worst pain intensity for individuals with chronic painful CIPN. The secondary outcomes were average pain intensity, non-painful CIPN symptom severity, global impression of change, and pain interference. We also explored the mediating of effect changes in anxiety, sleep-related impairment, fatigue, and depression on improvements in worst CIPN pain intensity following PROSPECT.

Sixty patients with chronic painful CIPN were randomized in a 1:1 ratio to receive either eight weeks of self-guided PROSPECT or treatment as usual. A seven-day worst CIPN pain intensity diary and standardized measures of the secondary outcomes were administered at the baseline and eight-week time points. Mean change scores between baseline and eight-week survey data were evaluated between groups using ANCOVA adjusting for baseline. Causal mediation analyses were conducted to examine mediators of worst pain intensity improvement following PROSPECT.

Individuals who received the PROSPECT intervention had significant improvements in worst CIPN pain intensity in comparison to individuals receiving usual care (p=0.046; d=0.54) (n=38). There were no significant mean change score differences between groups for the secondary outcomes. Improvements in anxiety (β=-0.10, CI=-0.55–0.37) explained the greatest proportion of the treatment effect on worst CIPN pain intensity, however, none of the hypothesized mediators had a statistically significant influence on the primary outcome. (n=37).

PROSPECT improved worst pain intensity, but not secondary outcomes, in individuals with chronic painful CIPN. A larger, adequately powered study testing PROSPECT is needed to determine if improvements in worst pain intensity may be sustained, to evaluate PROSPECT’s effect on the secondary outcomes, and to identify mediators of pain-intensity-related improvement. If shown to be efficacious with further testing, PROSPECT may be added to pharmacological modalities for the treatment of chronic painful CIPN.