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

Not Applicable

Completed

• Conditions: Obesity; Endometrial Carcinoma
• Interventions: Procedure: Gentle yoga therapy; Other: educational intervention; Other: counseling intervention; Other: quality-of-life assessment; Other: questionnaire administration

• Registration Number: NCT02465541
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2013-07-23
• Study First Submitted: 2014-05-16
• Primary Completion: 2014-06-10
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Study Completion: 2022-04-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (gentle yoga and dietary counseling)	Gentle yoga therapy	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 I (gentle yoga and dietary counseling)	counseling intervention	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 (enhanced usual care)	questionnaire administration	Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
Arm II (enhanced usual care)	quality-of-life assessment	Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
Arm I (gentle yoga and dietary counseling)	quality-of-life assessment	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 I (gentle yoga and dietary counseling)	questionnaire administration	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 (enhanced usual care)	educational intervention	Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States