Yoga in Treating Sleep Disturbance in Cancer Survivors (YOCAS)
RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.
PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
Psychosocial Effects of Cancer and Its Treatment
Procedure: fatigue assessment and management
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Procedure: sleep disorder therapy
Procedure: yoga therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Yoga for Persistent Sleep Disturbance in Cancer Survivors|
- Efficacy of Hatha yoga in improving sleep quality as measured by Pittsburgh Sleep Quality Inventory and Insomnia Severity Index [ Designated as safety issue: No ]
- Efficacy of yoga in improving fatigue and quality of life (QOL) as measured by Functional Assessment of Chronic Illness Therapy-Fatigue and Sleep Medication and Complimentary and Alternative Medicine Usage questionnaires [ Designated as safety issue: No ]
- Efficacy of yoga in improving fatigue and QOL as measured by Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Profile of Mood States, and Aerobic Center Longitudinal Study Physical Activity questionnaires [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||April 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- 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.
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Missouri|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|United States, New York|
|CCOP - Hematology-Oncology Associates of Central New York|
|East Syracuse, New York, United States, 13057|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43215|
|United States, Oregon|
|CCOP - Columbia River Oncology Program|
|Portland, Oregon, United States, 97225|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|United States, Washington|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|Principal Investigator:||Karen M. Mustian, PhD||University of Rochester|