Trial Information

Yoga for Persistent Sleep Disturbance in Cancer Survivors

OBJECTIVES:

Primary

- Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors
experiencing persistent sleep disturbance.

Secondary

- Determine the efficacy of yoga in improving fatigue and quality of life (QOL) of cancer
survivors.

- Determine if the positive effects of yoga on sleep are related to concurrent changes in
fatigue and QOL.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤
5 vs > 5). Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga
intervention immediately after study completion.

- Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions
of Hatha yoga per week for 4 weeks.

All patients complete Pittsburgh Sleep Quality Inventory, Insomnia Severity Index,
Functional Assessment of Chronic Illness Therapy-Fatigue, Sleep Medication and Complementary
and Alternative Medicine Usage, Symptom Inventory, Multidimensional Fatigue Symptom
Inventory, Profile of Mood States, and Aerobic Center Longitudinal Study Physical Activity
questionnaires at baseline and at study completion. Patients also wear an actigraph (a
device worn on the wrist to measure activity level) for 1 week before and for 1 week after
completion of study intervention. Patients also complete daily diaries for the duration of
the study.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.