- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575845
The Effect of Yoga on Barriers to Occupational Engagement in African American Breast Cancer Survivors
The purpose of this study was to determine if occupational therapy informed yoga could decrease barriers to occupational engagement in African American breast cancer survivors.
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Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast cancer disproportionately affects African American women as illustrated by a 42% higher death rate and an 11% lower 5-year survival rate when compared to Caucasian women. Reasons for these disparities include biological and structural barriers to higher survival rates.
Regular physical activity and resistance training are recommended to support improved survivorship. To date, few efforts have targeted African American survivors who may experience greater survivorship challenges than Caucasians.
Yoga is a safe and effective means for breast cancer survivors to exercise and gain positive physical and psychosocial outcomes. Only two studies, 10 years apart, have provided evidence about the efficacy of yoga for African American breast cancer survivors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- African American race
- Breast Cancer survivor
- No medical restrictions on activity
Exclusion Criteria:
- Race other than African American
- No history of breast cancer
- Medical restrictions on activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Occupational therapy informed yoga
Occupational therapists adapted postures to meet the abilities and rehabilitation needs of individual breast cancer survivors engaging in group-delivered yoga sessions
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Occupational therapy informed yoga met weekly for six, 60-minute sessions.
Each session started with a seated warm-up to coordinate breath and movement and promote upper extremity mobility.
Standing postures followed to target balance.
Sessions closed with restorative postures in seated and supine variations.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dynamic balance
Time Frame: Week 1 & week 6
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Dynamic balance measured with Functional Reach Assessment
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Week 1 & week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain
Time Frame: Week 1 & week 6
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Universal Pain Assessment Tool
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Week 1 & week 6
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Change in Mental Health
Time Frame: Week 1 & week 6
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Mental health subscale of Short Form Health Survey (SF-36)
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Week 1 & week 6
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie H Hunley, PhD, Mount Mary University
Publications and helpful links
General Publications
- Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
- Taylor TR, Barrow J, Makambi K, Sheppard V, Wallington SF, Martin C, Greene D, Yeruva SLH, Horton S. A Restorative Yoga Intervention for African-American Breast Cancer Survivors: a Pilot Study. J Racial Ethn Health Disparities. 2018 Feb;5(1):62-72. doi: 10.1007/s40615-017-0342-4. Epub 2017 Apr 14.
- Daly B, Olopade OI. A perfect storm: How tumor biology, genomics, and health care delivery patterns collide to create a racial survival disparity in breast cancer and proposed interventions for change. CA Cancer J Clin. 2015 May-Jun;65(3):221-38. doi: 10.3322/caac.21271. Epub 2015 Apr 9.
- Coughlin SS, Yoo W, Whitehead MS, Smith SA. Advancing breast cancer survivorship among African-American women. Breast Cancer Res Treat. 2015 Sep;153(2):253-61. doi: 10.1007/s10549-015-3548-3. Epub 2015 Aug 25.
- Mollica M, Newman SD. Breast cancer in African Americans: from patient to survivor. J Transcult Nurs. 2014 Oct;25(4):334-40. doi: 10.1177/1043659614524248. Epub 2014 Mar 4.
- Bower JE, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Greendale G. Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial. Cancer. 2012 Aug 1;118(15):3766-75. doi: 10.1002/cncr.26702. Epub 2011 Dec 16.
- Harder H, Parlour L, Jenkins V. Randomised controlled trials of yoga interventions for women with breast cancer: a systematic literature review. Support Care Cancer. 2012 Dec;20(12):3055-64. doi: 10.1007/s00520-012-1611-8. Epub 2012 Oct 6.
- Littman AJ, Bertram LC, Ceballos R, Ulrich CM, Ramaprasad J, McGregor B, McTiernan A. Randomized controlled pilot trial of yoga in overweight and obese breast cancer survivors: effects on quality of life and anthropometric measures. Support Care Cancer. 2012 Feb;20(2):267-77. doi: 10.1007/s00520-010-1066-8. Epub 2011 Jan 5.
- Levine AS, Balk JL. Yoga and quality-of-life improvement in patients with breast cancer: a literature review. Int J Yoga Therap. 2012;(22):95-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150820
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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