Yoga in Treating Sleep Disturbance in Cancer Survivors

Cancer Clinical Trial

— YOCAS  

Official title:

Yoga for Persistent Sleep Disturbance in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397930
• Other study ID #: CDR0000515123
• Secondary ID: U10CA037420URCC
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2006
• Last updated: October 13, 2015
• Start date: October 2006
• Est. completion date: June 2013

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 120 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Dyssomnias
• Fatigue
• Parasomnias
• Sleep Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	CCOP - Greenville	Greenville	South Carolina
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No