Yoga in Treating Sleep Disturbance in Cancer Survivors (YOCAS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00397930
First received: November 9, 2006
Last updated: January 31, 2013
Last verified: January 2013
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Karen M. Mustian, PhD University of Rochester
  More Information

Additional Information:
No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Rochester
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: January 31, 2013
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 August 21, 2014