Yoga in Treating Sleep Disturbance in Cancer Survivors - Full Text View

Sponsor:	University of Rochester
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Rochester
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 Survivor Fatigue Psychosocial Effects of Cancer and Its Treatment Sleep Disorders	Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: quality-of-life assessment Procedure: sleep disorder therapy Procedure: yoga therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Supportive Care
Official Title:	Yoga for Persistent Sleep Disturbance in Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fatigue Sleep Disorders

U.S. FDA Resources

Further study details as provided by University of Rochester:

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
Study Completion Date:	April 2010
Primary Completion Date:	June 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
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

University of Rochester

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Karen M. Mustian, PhD

University of Rochester

More Information

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00397930 History of Changes
Other Study ID Numbers:	CDR0000515123, U10CA037420, URCC-U3905, URCC-04-01
Study First Received:	November 9, 2006
Last Updated:	November 8, 2010
Health Authority:	United States: Federal Government

Keywords provided by University of Rochester:

psychosocial effects of cancer and its treatment
fatigue
cancer survivor
sleep disorders

Additional relevant MeSH terms:

Fatigue
Sleep Disorders
Dyssomnias
Parasomnias

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012