Chaoul, A., Milbury, K., Spelman, A., Basen-Engquist, K., Hall, M.H., Wei, Q., . . . Cohen, L. (2018). Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy. Cancer, 124, 36–45.

The purpose was to conduct a randomized control clinical trial examining the effects of a Tibetan yoga program compared to stretching and usual care group on sleep and fatigue among patients with breast cancer receiving chemotherapy.

Upon consent, patients completed a seven-day baseline assessment using actigraphy. At completion of baseline, patients were randomized to one of three treatment groups: Tibetan yoga, stretching, or usual care using adaptive randomization, minimization (age, stage of disease, time since diagnosis, baseline fatigue scores, menopausal status, surgical history, and chemotherapy regimen). Tibetan yoga and stretching groups attended four classes with trained instructors that ranged from 75 to 90 minutes each during chemotherapy. Patients then received three in-home booster sessions over six months. During the entire trial, patients were encouraged to practice at home. Long-term follow-up assessments were completed at 1 week and 3, 6, and 12 months postintervention. The usual care group was instructed not to perform yoga during the study period but given the opportunity to participate in yoga classes at the end of the study.

• N = 227
• AGE: Mean 49.63 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer stages 1-3
• OTHER KEY SAMPLE CHARACTERISTICS: Newly diagnosed before starting treatment

• SITE: Not stated or unknown   
• SETTING TYPE: Multiple settings    
• LOCATION: Large medical setting, MD Anderson Houston

PHASE OF CARE: Multiple phases of care

Randomized controlled trial

• Primary outcomes: Sleep was measured using self-reported Pittsburgh Sleep Quality Index (PSQI); fatigue was measured using the Brief Fatigue Inventory.
• Secondary outcomes included objective sleep using actigraphy.

Of the 352 that completed baseline, 74 were randomized to yoga group, 68 to the stretching, and 85 to the wait-list. There were no group differences noted in demographics in the three sample groups. The dropout rate in each group was similar. PSQI global sleep scores were significantly lower in participants who completed the intervention (p = 0.04). The majority of patients in both intervention groups completed all sessions (73% yoga, 74% stretching). No group differences were noted on completeness and practice in both groups. For main outcomes, no significant differences in sleep or fatigue were noted between groups over time. Within-group differences were noted with PSQI sleep disturbances, where the yoga group had significantly lower disturbances after week 1 postintervention compared to stretching (p = 0.03) and usual care (p=0.02). Actigraphy data showed reduced wake after sleep onset (in minutes) for yoga compared to stretching (p = 0.0003) and usual care (p = 0.0002).

The completion of four sessions of Tibetian yoga provided short-term reduction in subjective and objective sleep outcomes compared to stretching but not to usual care. Practicing outside of the intervention setting showed better outcomes in sleep. There was also support to ensure that yoga instruction occurred in-person to maximize patient outcomes and benefit.

• Risk of bias (no blinding)
• Findings not generalizable
• Questionable protocol fidelity
• Other limitations/explanation: Large number of participants were lost to follow-up.

Outcomes from this trial provide nurses with additional evidence that yoga could be beneficial for sleep-wake disturbances. However, the results are viewed with caution as the intervention did not show significant improvement compared to usual care.