Endometrial Carcinoma, Obesity
Conditions
Keywords
Cancer Survivors, Yoga, Endometrial Cancer
Brief summary
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
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.
Interventions
PROCEDUREGentle yoga therapy
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.
OTHERcounseling intervention
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
OTHEReducational intervention
Undergo enhanced usual care
OTHERquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB). | Up to 14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examine intervention feasibility using a composite assessment. | Up to 14 weeks | Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate. |
Other
| Measure | 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 |
Countries
United States
Outcome results
None listed