Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-13005

Full Title

Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of both Aerobic and Yoga based Exercise Programs

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 Objective

PRIMARY OBJECTIVES:

I. To determine the feasibility and efficacy of a combined lifestyle intervention (yoga + diet) for endometrial cancer survivors.

SECONDARY OBJECTIVES:

I. To determine the efficacy of a lifestyle intervention involving yoga to positively impact physical function and quality of life outcomes.

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.

Are you eligible?

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

Endometrial Cancer Gynecologic Cancers