Gentle Yoga and Dietary Counseling in Improving Physical Function and Quality of Life in Stage I-II Endometrial Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of a Gentle Yoga Based Exercise Program

Conditions
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Obesity, Endometrial Carcinoma

Intervention / Treatment
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* Procedure: Gentle yoga therapy
* Other: counseling intervention
* Other: educational intervention
* Other: quality-of-life assessment
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Previous diagnosis of grade 1 or 2, stage I or II endometrioid endometrial cancers (type I cancers) as confirmed during surgical intervention for treatment Overweight or obese (> 25 kg/m^2) Anytime from treatment Treating oncologist consent Primary physician consent to engage in physical activity unsupervised Ambulatory or able to engage in walking for at least 15 minutes Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week Exclusion Criteria: No prior type I endometrial cancer diagnosis Prior diagnosis of other cancer Currently (previous 6 months) engaged in structured exercise either aerobic or yoga based Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician Non-ambulatory Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit Major mental illness (e.g., schizophrenia, major depressive disorder) Unwilling to give consent
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (gentle yoga and dietary counseling)<br>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. | Procedure: Gentle yoga therapy<br>* 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.<br>* Other names: yoga;Other: counseling intervention<br>* Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.<br>* Other names: counseling and communications studies;Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (enhanced usual care)<br>Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks. | Other: educational intervention<br>* Undergo enhanced usual care<br>* Other names: intervention, educational;Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivors, Yoga, Endometrial Cancer