Yoga in Treating Sleep Disturbance in Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance. 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.

Official Title
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Yoga for Persistent Sleep Disturbance in Cancer Survivors

Conditions
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Fatigue, Cancer, Sleep Disorders

Intervention / Treatment
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* Procedure: Standard Care Control Condition
* Procedure: Yoga Intervention (YOCAS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Intervention (YOCAS)<br>Standardized Yoga for Cancer Survivors (YOCAS) | Procedure: Yoga Intervention (YOCAS)<br>* The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.<br>|
| Experimental: Standard Care Control Condition<br>Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. | Procedure: Standard Care Control Condition<br>* Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) | Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms. | 2-24 months after surgery, chemotherapy, and/or radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer-related sleep disturbance, fatigue, sleep disorders