NCT00397930

Yoga in Treating Sleep Disturbance in Cancer Survivors

Yoga for Persistent Sleep Disturbance in Cancer Survivors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Gary Morrow · Academic / Other
• Sex: All
• Age: 21 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Fatigue
• Cancer
• Sleep Disorders

Interventions

Type	Name	Description
PROCEDURE	Standard Care Control Condition	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.
PROCEDURE	Yoga Intervention (YOCAS)	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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2006-11-10
• Last updated: 2017-02-20
• Results posted: 2015-03-17

Locations

11 sites across 1 country: United States