|Phase II||Supportive care||Completed||21 and over||NCI, Other||CDR0000515123|
U10CA037420, URCC-U3905, URCC-04-01, NCT00397930
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.
Further Study Information
- 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.
- Diagnosis of any type of cancer
- More than 1 primary cancer allowed
- No metastatic cancer
- Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
- Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
- No diagnosis of sleep apnea
- Able to read English
- No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
PRIOR CONCURRENT THERAPY:
- No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
Trial Lead Organizations/Sponsors
James P. Wilmot Cancer Center at University of Rochester Medical CenterNational Cancer Institute
|Karen M. Mustian||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00397930
ClinicalTrials.gov processed this data on October 17, 2013
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