Trial record 13 of 1579 for:
"Sleep Disorders"
Yoga in Treating Sleep Disturbance in Cancer Survivors (YOCAS)
This study has been completed.
Sponsor:
University of Rochester
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
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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) |
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
Investigators
| Principal Investigator: | Karen M. Mustian, PhD | University of Rochester |
More Information
Additional Information:
No publications provided
| 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 May 23, 2013