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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00770 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle change effects physical function and quality of life of endometrial cancer survivors. Gentle yoga and dietary counseling may help improve physical function and quality of life for stage I-II endometrial cancer survivors.
PRIMARY OBJECTIVES:
I. To determine the feasibility and efficacy of a combined lifestyle intervention (yoga + diet) to positively impact physical function and quality of life for endometrial cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks.
ARM II: Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (gentle yoga and dietary counseling) | Experimental | Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks. |
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| Arm II (enhanced usual care) | Active Comparator | Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentle yoga therapy | Procedure | Mindfulness in Motion is a mindfulness based intervention that is an 8-10 week program for adults interested in learning a practical strategy for stress reduction, intended to be delivered on the worksite or home. |
| Measure | Description | Time Frame |
|---|---|---|
| Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB). | Physical function will be assess using a SPPB walk performance assessment. Quality life will be assessed via the SF-36 and the Functional Assessment of Cancer Therapy-Endometrial FACT-EN. | Up to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Examine intervention feasibility using a composite assessment. | Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate. | Up to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy: General) | Up to 14 weeks | |
| Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ) | Up to 14 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Focht, PhD, FACSM | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| counseling intervention | Other | Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian. |
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| educational intervention | Other | Undergo enhanced usual care |
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| quality-of-life assessment | Other | Ancillary studies |
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| questionnaire administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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