An interventional study of Gentle yoga therapy and counseling intervention in Obesity and Endometrial Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 16 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: counseling intervention · Other: quality-of-life assessment · Other: questionnaire administration
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 · Other: quality-of-life assessment · Other: questionnaire administration
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.
Also known as: yoga
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
Also known as: counseling and communications studies
Undergo enhanced usual care
Also known as: intervention, educational
Ancillary studies
Also known as: quality of life assessment
Ancillary studies
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.
Time frame: Up to 14 weeks
Examine intervention feasibility using a composite assessment.
Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate.
Time frame: Up to 14 weeks
Change from baseline in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy: General)
Time frame: Up to 14 weeks
Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ)
Time frame: Up to 14 weeks
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center