Breast Neoplasm FemaleNCT03575845
The Effect of Yoga on Barriers to Occupational Engagement in African American Breast Cancer Survivors
A study testing Occupational Therapy Informed Yoga in people with Breast Neoplasm Female, run by Mount Mary University.
Trial summary
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. . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Occupational Therapy Informed Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2015to 24 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American race
- Breast Cancer survivor
- No medical restrictions on activity
Who cannot join
- Race other than African American
- No history of breast cancer
- Medical restrictions on activity
About this study
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.
.
Read the 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.
- Conditions
- Breast Neoplasm Female
- Being tested
- Occupational Therapy Informed Yoga
- Keywords
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy Informed YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Occupational therapy informed yoga | Experimental | Occupational therapists adapted postures to meet the abilities and rehabilitation needs of individual breast cancer survivors engaging in group-delivered yoga sessions Receives: Behavioral: Occupational Therapy Informed Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dynamic balance
Dynamic balance measured with Functional Reach Assessment
Measured: Week 1 & week 6
Secondary outcomes (2)
Change in Pain
Universal Pain Assessment Tool
Measured: Week 1 & week 6
Change in Mental Health
Mental health subscale of Short Form Health Survey (SF-36)
Measured: Week 1 & week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start5 Jun 2015
- Primary completion16 Jul 2015
- Study completion24 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm pretest-posttest design
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Mary University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie H Hunley, Mount Mary University
- Investigators
- Julie H Hunley, PhD, Principal investigator, Mount Mary University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575845
- Sponsor's protocol ID
- 20150820
- Status last verified
- Jun 2018
- First submitted
- 17 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17785709Taylor 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.
PubMed 28411330Daly 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.
PubMed 25960198Coughlin 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.
PubMed 26303657Mollica 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.
PubMed 24595162Bower 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.
PubMed 22180393Harder 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.
PubMed 23052917Littman 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.
PubMed 21207071Levine 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.
PubMed 23070679
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Barriers to Occupational Engagement in African American Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03575845
- Acronym / sponsor ID
- 20150820
- Conditions
- Breast Neoplasm Female
- Keywords
- Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mount Mary UniversityUniversity, hospital or other
- Study start
- 5 Jun 2015 (actual)
- Primary completion
- 16 Jul 2015 (actual)
- Study completion
- 24 Oct 2015 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm pretest-posttest design
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy informed yoga | Experimental | Behavioral: Occupational Therapy Informed YogaOccupational therapists adapted postures to meet the abilities and rehabilitation needs of individual breast cancer survivors engaging in group-delivered yoga sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African American race
- Breast Cancer survivor
- No medical restrictions on activity
Key exclusion criteria (3 listed)
- Race other than African American
- No history of breast cancer
- Medical restrictions on activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Therapy Informed YogaOccupational 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. | Behavioural | Occupational therapy informed yoga |
Primary outcome
Change in dynamic balance
Time frame: Week 1 & week 6
Dynamic balance measured with Functional Reach Assessment
2 secondary outcomes
Change in Pain
Time frame: Week 1 & week 6
Change in Mental Health
Time frame: Week 1 & week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Background: PubMed 17785709Moadel 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.
- Background: PubMed 28411330Taylor 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.
- Background: PubMed 25960198Daly 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.
- Background: PubMed 26303657Coughlin 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.
- Background: PubMed 24595162Mollica 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.
- Background: PubMed 22180393Bower 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.
- Background: PubMed 23052917Harder 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.
- Background: PubMed 21207071Littman 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.
- Background: PubMed 23070679Levine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie H Hunley, PhD principal investigator
Mount Mary University
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy Informed Yoga in people with Breast Neoplasm Female, run by Mount Mary University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dynamic balance (time frame: Week 1 & week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575845, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.