Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer

Objective This study evaluated a three-session acceptance-based cognitive behavioral -acceptance and commitment therapy (CBT-ACT) intervention targeting a common symptom cluster in advanced cancer-worry-insomnia-depression-fatigue. Methods Twenty-eight patients with advanced cancer were randomly assigned to the CBT-ACT intervention or waitlist. At preintervention, participants completed a psychodiagnostic interview, standardized questionnaires, and a sleep diary. Intervention and waitlist groups were reassessed after 6 weeks, at which point the waitlist group completed the intervention. Results Participants receiving the intervention demonstrated improved sleep efficiency (P = 0.0062, d = 1.08), sleep latency (P = 0.028, d = -0.86), insomnia severity (P = 0.0047, d = -1.18), and worry (P = 0.026, d = -0.89) compared with waitlist controls. They also demonstrated a 7-point reduction on depression (P = 0.03, d = -0.88), reduced hyperarousal (P = 0.005, d = -1.51), and a decrease in distress (P = 0.032, d = -0.83). Effects were maintained for the whole sample in sensitivity analyses. Effects on uncertainty intolerance approached significance (P = 0.058). No effect was found on fatigue. Conclusions The CBT-ACT group performed significantly better than the waitlist control group. CBT-ACT yielded strong effects for worry, sleep, depression, emotional distress, total distress, and hyperarousal. Future studies will enhance the fatigue and uncertainty tolerance components of the intervention.