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PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
- Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.
- 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.
Allocation: Randomized, Control: Active Control, Primary Purpose: Supportive Care
fatigue assessment and management, management of therapy complications, quality-of-life assessment, sleep disorder therapy, yoga therapy
CCOP - Central Illinois
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:41:39-0400
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