Yoga in Treating Sleep Disturbance in Cancer Survivors (YOCAS)

January 3, 2017 updated by: Gary Morrow

Yoga for Persistent Sleep Disturbance in Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
    • New York
      • East Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
    • Oregon
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
    • Washington
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary Morrow

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen M. Mustian, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000515123
  • U10CA037420 (U.S. NIH Grant/Contract)
  • URCC U3905 (Other Identifier: University of Rochester)
  • URCC-04-01 (Other Identifier: NCI/DCP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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