Effects of yoga, cognitive behavioral therapy, and a behavioral placebo on sleep: A nationwide multicenter phase III RCT in cancer survivors.
Authors: Po-Ju Lin, Charles E. Heckler, Eva Culakova, Huiwen Xu, Richard Francis Dunne, Nikesha Gilmore, Sara Hardy, Amber Kleckner, Ian Kleckner, Kah Poh Loh, Michelle Christine Janelsins, Luke Joseph Peppone, Amy C. Vander Woude, Alison Katherine Conlin, Anthony John Jaslowski, Karen Michelle Mustian
Journal: Journal of Clinical Oncology (2021)

12017 Background: Patients commonly experience impaired sleep throughout cancer treatment and for years into survivorship. Impaired sleep may mediate other cancer-related symptoms and can lead to the inability to complete daily activities and lower quality of life. More effective non-pharmacological treatment options for impaired sleep are needed. We conducted a nationwide, multicenter, phase III randomized controlled trial (RCT) comparing the effects of yoga (Yoga for Cancer Survivors; YOCAS), cognitive behavioral therapy for insomnia (CBT-I), and a behavioral placebo on impaired sleep in cancer survivors. Methods: This RCT was conducted via the URCC NCORP Research Base. Participants were cancer survivors 2-60 months post-treatment with insomnia. They were randomized to 1) YOCAS (75-min session biweekly for 4 wks), 2) CBT-I (90-min session weekly for 8 wks), and 3) behavioral placebo (survivorship health education per ASCO guidelines; 75-min session biweekly for 4 wks). Sleep efficiency, sleep duration, wake after sleep onset (WASO), and sleep latency were assessed via actigraphy at baseline and post-intervention. Actigraphs were worn on the non-dominant wrist 24 hours a day for 7 days. Linear mixed models were used to assess intervention effects on sleep outcomes. Results: 740 survivors were enrolled (93% female, mean age 56±11 years, 73% breast cancer). Results revealed significant group differences among survivors in the 3 arms in sleep efficiency, sleep duration, and WASO (all p&lt;0.05), but not in sleep latency (p&gt;0.05). YOCAS and CBT-I subjects maintained sleep efficiency (mean change= -0.8% and -0.03%, respectively, all p&gt;0.05) while behavioral placebo subjects significantly reduced sleep efficiency (mean change= -3.4%, p&lt;0.01). When controlling for baseline, YOCAS and CBT-I subjects demonstrated better sleep efficiency compared to behavioral placebo subjects at post-intervention (all p&lt;0.05). YOCAS subjects also maintained sleep duration (mean change= -3.5 minutes, p&gt;0.05) while CBT-I and behavioral placebo subjects significantly reduced sleep duration (mean change= -20.3 minutes and -26.6 minutes, respectively, all p&lt;0.01). When controlling for baseline, YOCAS subjects demonstrated longer sleep duration compared to CBT-I and behavioral placebo subjects at post-intervention (all p&lt;0.05). There were no significant within-group changes in WASO over time in the 3 arms. When controlling for baseline, CBT-I subjects demonstrated a trend toward lower WASO compared to YOCAS (p=0.07) and behavioral placebo (p=0.05) subjects at post-intervention. Conclusions: Both YOCAS and CBT-I maintained sleep efficiency and/or sleep duration among cancer survivors. Oncologists should consider prescribing yoga and CBT-I for treating impaired sleep in cancer survivors. Funding: NCI UG1CA189961, R01CA181064, T32CA102618. Clinical trial information: NCT02613364.