Effects Of Yoga Vs. A Behavioral Placebo On Cancer-related Fatigue Among Cancer Survivors

Abstract

Cancer-related fatigue (CRF) is a multidimensional treatment-related toxicity that is commonly experienced by patients with cancer. We have previously shown that yoga (i.e., Yoga for Cancer Survivors, YOCAS©®), compared to usual care, significantly reduced CRF in cancer survivors at post-intervention. Whether yoga is more effective than a rigorous behavioral placebo (i.e., Survivorship Health Education, SHE) for treating CRF and whether those improvements are sustained 3 and 6 months after the completion of the intervention are unknown. PURPOSE: We conducted a nationwide, multicenter, blinded, phase III RCT comparing the effects of yoga with a behavioral placebo on CRF at post-intervention, and 3 and 6 months later in cancer survivors. METHODS: Cancer survivors 2-60 months post-treatment with insomnia, no distant metastatic disease, and no yoga participation within 3 months prior were randomized to receive eight 75-minute YOCAS©® or SHE sessions (2x/wk. for 4 wks.). CRF was assessed by the Multidimensional Fatigue Symptom Inventory, which generates an overall CRF score and 5 CRF subdomain scores (i.e., general, physical, emotional, and mental fatigue and vigor), at baseline, post-intervention, and 3 and 6 months after completing the interventions. Mixed linear models were used to assess intervention effects on CRF. RESULTS: 502 eligible cancer survivors (94% women, mean age 56 yrs., 74% breast cancer) were randomized to YOCAS©® (n = 251) or SHE placebo (n = 251). YOCAS©® participants demonstrated significantly greater improvements in overall CRF (-3.7 ± 1.4), general (-1.8 ± 0.5), and mental (-0.7 ± 0.4) CRF subdomains, compared to SHE placebo participants, at post-intervention (all p ≤ 0.05). YOCAS©® participants also showed greater improvements, compared to SHE placebo participants, in overall (-2.4 ± 1.5, p ≤ 0.10), general (-1.1 ± 0.5, p ≤ 0.05), and mental (-0.6 ± 0.4, p ≤ 0.10) CRF 3 months later, with no group differences in overall CRF or subdomains of CRF at the 6-month follow-up. CONCLUSIONS: YOCAS©® is effective for treating overall CRF, as well as, general and mental subdomains of CRF, among cancer survivors immediately post-intervention with improvements in CRF sustained 3 months later. YOCAS©® should be recommended for treating CRF in survivors. Funding: NCI UG1CA189961, R01CA181064, T32CA102618