Columbus, Ohio 43210


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02465541


Primary Contact:

Principal Investigator
Brian Focht, PhD, FACSM
Ohio State University Comprehensive Cancer Center

Ohio State University Comprehensive Cancer Center
Phone: 1-800-293-5066
Email: Jamesline@osumc.edu


Backup Contact:

Email: bfocht@ehe.osu.edu
Brian Focht, PhD, FACSM
Phone: 614-293-0757


Location Contact:

Columbus, Ohio 43210
United States

Brian C. Focht
Phone: 614-292-0757
Email: bfocht@ehe.osu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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