Light Enhanced Cognitive Behavioral Therapy (CBT-I+Light) for Insomnia and Fatigue During Chemotherapy for Breast Cancer: A Randomized Controlled Trial.

STUDY OBJECTIVES Sleep problems are common during chemotherapy for breast cancer (BC). We evaluated whether combined brief cognitive behavioral and bright light therapy (CBT-I+Light) is superior to treatment as usual with relaxation audio (TAU+) for insomnia symptoms and sleep efficiency (primary outcomes). METHODS We randomized women receiving intravenous chemotherapy, stratified by tumor stage and insomnia severity index (ISI), to 6-weeks CBT-I+Light or TAU+. CBT-I+Light included one in-person session, one telephone call, seven emails, and 20 minutes bright light each morning. TAU+ comprised usual treatment and two emails with relaxation audio tracks. Patient-reported outcomes were assessed at baseline, midpoint (week 3), post (week 6) and 3-month follow-up. RESULTS Women (N = 101) were randomly assigned to CBT-I+Light or TAU+. The CBT-I+Light group showed significantly greater improvement in insomnia symptoms than the TAU+ group (-5.06 vs -1.93, P = .009; between-group effect size [ES] = .69). At 3-month follow-up, both groups were lower than baseline but did not differ from each other (between-group ES = .18, P = .56). CBT-I+Light had higher patient-reported sleep efficiency than TAU+ immediately after the start of intervention (P = .05) and significantly greater improvement in fatigue (between-group ES = .59, P = .013) and daytime sleep-related impairment (between-group ES = .61, P = .009) than the TAU+ group. CONCLUSION CBT-I+Light had a clinically significant impact on insomnia and fatigue with moderate effect sizes. Results support offering cognitive behavioral therapy for insomnia and bright light therapy during chemotherapy for breast cancer to help manage sleep and fatigue.