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

The Ohio State University

Status: Completed

Conditions: Endometrial Carcinoma; Obesity

Treatments: Other: educational intervention; Other: counseling intervention; Procedure: Gentle yoga therapy; Other: quality-of-life assessment; Other: questionnaire administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02465541

OSU-13005

NCI-2014-00770 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Arm I (gentle yoga and dietary counseling)

Experimental group

Description:

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.

Treatment:

Other: quality-of-life assessment

Procedure: Gentle yoga therapy

Other: counseling intervention

Other: questionnaire administration

Arm II (enhanced usual care)

Active Comparator group

Description:

Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.

Treatment:

Other: quality-of-life assessment

Other: educational intervention

Other: questionnaire administration