Light Enhanced Cognitive Behavioral Therapy (CBT+) 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 + ) 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 + or TAU + . CBT + 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 + or TAU + . Insomnia symptoms declined significantly more from baseline to post with CBT + versus TAU + (−5.06 vs -1.93, P = .009; effect size [ES] = .69). At 3-month follow-up, both groups had improved insomnia symptoms but did not differ (ES = .18, P = .56). CBT + had higher patient-reported sleep efficiency than TAU + after the start of intervention ( P = .05) and more improvement in fatigue (ES = .59, P = .013) and daytime sleep-related impairment (ES = .61, P = .009) from baseline to post. Conclusions CBT + 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. Clinical trial information Registered with the Australian New Zealand Clinical Trials Registry ( http://anzctr.org.au/ ), Registration Number: ACTRN12618001255279 Statement of Significance Poor sleep is prevalent after cancer diagnosis, especially during chemotherapy. Although cognitive behavioral therapy for insomnia (CBT-I) has been shown to be effective, including in cancer survivors, chemotherapy is unique with significant, ongoing, exogenous factors disrupting sleep (e.g., pain, nausea, and steroids used to manage side effects from chemotherapy). We showed statistically and clinically significant improvements in insomnia and fatigue symptoms in the CBT-I plus bright light therapy (CBT + ) treatment condition compared to the control in women receiving chemotherapy for stage 1–4 breast cancer. Waiting until cancer treatment completion may result in prolonging poor sleep and our findings suggest is not necessary. Future studies are needed to evaluate whether combined CBT + is superior to CBT-I or light alone.