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| Name | Class |
|---|---|
| The Foundation for Barnes-Jewish Hospital | OTHER |
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The investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. The investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life compared to women not participating in the program. The investigators predict that this will be associated with decreased markers of inflammation. The investigators will also evaluate whether there is improved pathologic response rate compared to historical controls. This study will provide pilot data for a larger randomized controlled trial assessing whether program can provide long-term improvement in quality of life, weight maintenance, and the serum and tumor changes correlating with a reduced risk of recurrence and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Yoga | Experimental |
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| Arm 2: No Yoga | Active Comparator | -Patients in this arm will not receive a personalized yoga plan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled | -Feasibility is defined as the ability to enroll 60% of eligible patients | Completion of study enrollment (estimated to be 6 months) |
| Feasibility of conducting a larger randomized trial using yoga and mindful movement | -Feasibility is defined as the ability to have an 80% completion rate of the intervention | Completion of study enrollment (estimated to be 6 months) |
| Efficacy of yoga exercise as measured by weight change from baseline to completion | Completion of treatment (estimated to be 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only) | Completion of treatment (estimated to be 6 months) | |
| Effect of yoga exercise as measured by inflammatory markers | Completion of treatment (estimated to be 6 months) |
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Eligibility Critera:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay L Peterson, M.D., MSCR | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36412916 | Derived | 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. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Blood draw | Procedure |
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| FACT-G questionnaire | Behavioral |
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| Weight measurement | Procedure | -Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment |
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| Recent Physical Activity Questionnaire | Behavioral | -To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment. |
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| NHANES Food Questionnaire | Behavioral | -To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment. |
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| Effect of yoga exercise as measured by fatigue index | -Fatigue index will be measured by FACT-G questionnaire | Completion of treatment (estimated to be 6 months) |
| Effect of yoga exercise as measured by quality of life | -Quality of life will be measured by FACT-G questionnaire | Completion of treatment (estimated to be 6 months) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| D001800 | Blood Specimen Collection |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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