Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer
NCT ID: NCT03262831
Last Updated: 2019-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-01-10
2019-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1: Yoga
* Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
* Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
* The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
* During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
Yoga
The yoga practice, Gentle Hatha and Restorative Yoga, will be based on protocols that have been found to decease fatigue and weight gain by helping the participant gain insight in recognizing stress responses and ways to relax
Blood draw
* Baseline and end of treatment
* To evaluate change in inflammatory markers (CRP, IL-6, and TNF)
FACT-G questionnaire
* 7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days
* Answers range from 0=not at all to 4=very much
Weight measurement
-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment
Recent Physical Activity Questionnaire
-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.
NHANES Food Questionnaire
-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
Arm 2: No Yoga
-Patients in this arm will not receive a personalized yoga plan
Blood draw
* Baseline and end of treatment
* To evaluate change in inflammatory markers (CRP, IL-6, and TNF)
FACT-G questionnaire
* 7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days
* Answers range from 0=not at all to 4=very much
Weight measurement
-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment
Recent Physical Activity Questionnaire
-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.
NHANES Food Questionnaire
-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
Interventions
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Yoga
The yoga practice, Gentle Hatha and Restorative Yoga, will be based on protocols that have been found to decease fatigue and weight gain by helping the participant gain insight in recognizing stress responses and ways to relax
Blood draw
* Baseline and end of treatment
* To evaluate change in inflammatory markers (CRP, IL-6, and TNF)
FACT-G questionnaire
* 7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days
* Answers range from 0=not at all to 4=very much
Weight measurement
-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment
Recent Physical Activity Questionnaire
-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.
NHANES Food Questionnaire
-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18.
* Female.
* Newly diagnosed with Stage I-III breast cancer.
* Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy.
* Not currently regularly practicing yoga (defined as at least once a month).
* Able to read and understand English
* Able to understand and willing to sign an IRB-approved written informed consent document
18 Years
FEMALE
No
Sponsors
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The Foundation for Barnes-Jewish Hospital
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Lindsay L Peterson, M.D., MSCR
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Greaney SK, Amin N, Prudner BC, Compernolle M, Sandell LJ, Tebb SC, Weilbaecher KN, Abeln P, Luo J, Tao Y, Hirbe AC, Peterson LL. Yoga Therapy During Chemotherapy for Early-Stage and Locally Advanced Breast Cancer. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221137285. doi: 10.1177/15347354221137285.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201708076
Identifier Type: -
Identifier Source: org_study_id
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