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Yoga in Treating Sleep Disturbance in Cancer Survivors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: University of Rochester
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00397930
  Purpose

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 Intervention Phase
Cancer-Related Problem/Condition
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
 Procedure: fatigue assessment and management
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Procedure: sleep disorder therapy
Procedure: yoga therapy
 Phase II

MedlinePlus related topics: Cancer Sleep Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Active Control
Official Title: Yoga for Persistent Sleep Disturbance in Cancer Survivors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy of Hatha yoga in improving sleep quality as measured by Pittsburgh Sleep Quality Inventory and Insomnia Severity Index [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of yoga in improving fatigue and quality of life (QOL) as measured by Functional Assessment of Chronic Illness Therapy-Fatigue and Sleep Medication and Complimentary and Alternative Medicine Usage questionnaires [ Designated as safety issue: No ]
  • Efficacy of yoga in improving fatigue and QOL as measured by Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Profile of Mood States, and Aerobic Center Longitudinal Study Physical Activity questionnaires [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.

Secondary

  • Determine the efficacy of yoga in improving fatigue and quality of life (QOL) of cancer survivors.
  • Determine if the positive effects of yoga on sleep are related to concurrent changes in fatigue and QOL.

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.

All patients complete Pittsburgh Sleep Quality Inventory, Insomnia Severity Index, Functional Assessment of Chronic Illness Therapy-Fatigue, Sleep Medication and Complementary and Alternative Medicine Usage, Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Profile of Mood States, and Aerobic Center Longitudinal Study Physical Activity questionnaires at baseline and at study completion. Patients also wear an actigraph (a device worn on the wrist to measure activity level) for 1 week before and for 1 week after completion of study intervention. Patients also complete daily diaries for the duration of the study.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of any type of cancer

    • More than 1 primary cancer allowed
    • No metastatic cancer
    • Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
  • 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)
  • No diagnosis of sleep apnea

PATIENT CHARACTERISTICS:

  • Able to read English
  • 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

PRIOR CONCURRENT THERAPY:

  • No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397930

Locations
United States, Illinois
CCOP - Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade, MD     217-876-6600     jlwade3@sbcglobal.net    
United States, Kansas
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214-3882
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
United States, Michigan
CCOP - Grand Rapids Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Marianne K. Lange, MD     616-391-6299     marianne.lange@grcop.org    
CCOP - Kalamazoo Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Raymond S. Lord, MD     269-373-7488     rlord@wmcc.org    
United States, Missouri
CCOP - Kansas City Recruiting
Kansas City, Missouri, United States, 64131
Contact: Rakesh Gaur, MD     816-932-3300     rgaur@saint-lukes.org    
United States, New York
CCOP - Hematology-Oncology Associates of Central New York Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD     315-472-7504     jkirshner@hoacny.com    
United States, North Carolina
CCOP - Southeast Cancer Control Consortium Recruiting
Goldsboro, North Carolina, United States, 27534-9479
Contact: James N. Atkins, MD     336-777-3036        
United States, Ohio
CCOP - Columbus Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD     614-443-2267     kueblep@ohiohealth.com    
United States, Oregon
CCOP - Columbia River Oncology Program Recruiting
Portland, Oregon, United States, 97225
Contact: Keith S. Lanier, MD     503-216-1440        
United States, South Carolina
CCOP - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere, MD, FACP     864-241-6251        
United States, Washington
CCOP - Northwest Recruiting
Tacoma, Washington, United States, 98405-0986
Contact: Lauren K. Colman, MD     253-403-1677     lauren.colman@multicare.org    
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen M. Mustian, PhD University of Rochester
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000515123, URCC-U3905, URCC-04-01
Study First Received: November 9, 2006
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00397930  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
depression
fatigue
unspecified adult solid tumor, protocol specific
sleep disorders

Study placed in the following topic categories:
Signs and Symptoms
Depression
Fatigue
Mental Disorders
 Neurologic Manifestations
Dyssomnias
Sleep Disorders
Depressive Disorder

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009



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