YOCAS yoga, mood disturbance, and insomnia: A URCC NCORP RB nationwide, phase III, randomized, controlled trial with cancer survivors.

12004 Background: Mood disturbance (MoD) and insomnia are two of the most pervasive and troubling side effects experienced by cancer survivors for years after completing adjuvant treatments. MoD and insomnia significantly interfere with survivors’ ability to perform essential daily activities such as cleaning, grocery shopping, cooking, taking medications, driving, and communicating with others. We previously reported that Yoga for Cancer Survivors (YOCAS) is effective for treating insomnia. YOCAS may also alleviate MoD, and changes in MoD may mediate the influence of YOCAS on insomnia. Methods: We conducted a nationwide, multisite, phase III randomized, controlled trial to examine: 1) the effects of YOCAS on MoD (i.e., overall MoD, anxiety, and fatigue), and 2) whether changes in MoD mediate the association between YOCAS and changes in insomnia. Survivors were recruited via the University of Rochester Cancer Center NCI Community Oncology Research Program Research Base (URCC NCORP RB). Non-metastatic cancer survivors, between 2-24 months post adjuvant therapy, aged 21 or older, with moderate or greater sleep disruption, and with no participation in yoga during the prior 3 months, were randomized to two arms: 1) standard care and 2) standard care plus the 4-week YOCAS intervention (2x/week; 75 min/session). The YOCAS consists of breathing exercises, 18 gentle Hatha and Restorative yoga postures, and meditation. MoD and insomnia were assessed using the Profile of Mood States and Insomnia Severity Index, respectively, at pre- and post-intervention. Results: A total of 410 survivors, recruited from 12 community-based oncology practices across the USA, were randomized (mean age = 54 10.4 years; 96% female; 75% breast cancer survivors). ANCOVAs revealed YOCAS participants, compared to standard care participants, experienced significantly less overall MoD (Mean Difference [Standard Error] = -5.08 [1.36]), anxiety (MD [SE] = -0.72 [0.29]), and fatigue (MD [SE] = -1.49 [0.41]; all p < 0.05) at post-intervention. Additionally, YOCAS participants reported significant improvements from pre- to post-intervention on overall MoD, anxiety, and fatigue (all p < 0.05), whereas standard care participants did not. Causal mediation analyses revealed changes in overall MoD partially mediated (24.9%; 95% CI: 10.9%, 42.6%) the association between YOCAS and changes in insomnia. Changes in fatigue also partially mediated (24.6%; 95% CI: 11.3%, 43.9%) the association between YOCAS and changes in insomnia (all p < 0.05). Conclusions: YOCAS yoga is effective for treating overall MoD, anxiety, and fatigue among survivors. Additionally, improvements in insomnia stemming from YOCAS yoga may be mediated by changes in overall MoD and fatigue. Clinicians should consider recommending yoga for survivors who experience overall MoD, anxiety, fatigue, and insomnia. Clinical trial information: NCT00397930 .