Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
410 participants
INTERVENTIONAL
2006-10-31
2013-06-30
Brief Summary
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PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Yoga Intervention (YOCAS)
Standardized Yoga for Cancer Survivors (YOCAS)
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.
Standard Care Control Condition
Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Director, URCC NCORP Research Base
Principal Investigators
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Karen M. Mustian, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Northwest
Tacoma, Washington, United States
Countries
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References
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Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.
Arana-Chicas E, Lin PJ, Gada U, Sun H, Chakrabarti A, Mattick LJ, Rieth K, Chay CH, Ruzich J, Esparaz BT, Cupertino AP, Altman BJ, Vertino PM, Mohile SG, Mustian KM. The effect of YOCAS(c)(R) yoga on cancer-related fatigue and quality of life in older (60+) vs. younger (</= 59) cancer survivors: Secondary analysis of a nationwide, multicenter, phase 3 randomized controlled trial. J Geriatr Oncol. 2024 Nov;15(8):102076. doi: 10.1016/j.jgo.2024.102076. Epub 2024 Oct 4.
Lin PJ, Kleckner IR, Loh KP, Inglis JE, Peppone LJ, Janelsins MC, Kamen CS, Heckler CE, Culakova E, Pigeon WR, Reddy PS, Messino MJ, Gaur R, Mustian KM. Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419855134. doi: 10.1177/1534735419855134.
Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Palesh OG, Chandwani K, Reddy PS, Melnik MK, Heckler C, Morrow GR. Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. J Clin Oncol. 2013 Sep 10;31(26):3233-41. doi: 10.1200/JCO.2012.43.7707. Epub 2013 Aug 12.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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URCC U3905
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-04-01
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000515123
Identifier Type: -
Identifier Source: org_study_id
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