Yoga in Treating Sleep Disturbance in Cancer Survivors

Phase 2

Completed

Interventions: Procedure: Yoga Intervention (YOCAS)
Procedure: Standard Care Control Condition

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Yoga Intervention (YOCAS)	Yoga Intervention (YOCAS)	Standardized Yoga for Cancer Survivors (YOCAS)
Standard Care Control Condition	Standard Care Control Condition	Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses.

Primary Outcome Measures

Name	Time	Method
Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)	2-24 months after surgery, chemotherapy, and/or radiation therapy	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.

Secondary Outcome Measures

Name	Time	Method

Locations (11): CCOP - Greenville
🇺🇸
Greenville, South Carolina, United States
CCOP - Kansas City
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Kansas City, Missouri, United States
CCOP - Grand Rapids
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Grand Rapids, Michigan, United States
CCOP - Central Illinois
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Decatur, Illinois, United States
CCOP - Kalamazoo
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Kalamazoo, Michigan, United States
CCOP - Columbus
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Columbus, Ohio, United States
CCOP - Wichita
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Wichita, Kansas, United States
CCOP - Columbia River Oncology Program
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Portland, Oregon, United States
CCOP - Hematology-Oncology Associates of Central New York
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East Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium
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Goldsboro, North Carolina, United States
CCOP - Northwest
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Tacoma, Washington, United States