Clinical Trials (PDQ®)
|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.
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
- Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
- Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
- 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)
- Able to read English
- 21 years of age or older
- 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
- No diagnosis of sleep apnea
- No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
- No metastatic cancer
Trial Lead Organizations/Sponsors
Gary R. Morrow, PhD, MSNational Cancer Institute
|Karen M. Mustian||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00397930
ClinicalTrials.gov processed this data on March 16, 2015
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