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Yoga in Treating Sleep Disturbance in Cancer Survivors (YOCAS)

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ClinicalTrials.gov Identifier: NCT00397930
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : March 17, 2015
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

Study Description
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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.


Condition or disease Intervention/treatment Phase
Fatigue Cancer Sleep Disorders Procedure: Standard Care Control Condition Procedure: Yoga Intervention (YOCAS) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Yoga for Persistent Sleep Disturbance in Cancer Survivors
Study Start Date : October 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397930


Locations
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United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen M. Mustian, PhD University of Rochester
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT00397930    
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 )
First Posted: November 10, 2006    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: February 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:
cancer-related sleep disturbance
fatigue
sleep disorders
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Dyssomnias
Fatigue
 Nervous System Diseases
Neurologic Manifestations
Mental Disorders