Skip to main content
OpenTrials
Completed

NCT Number: NCT02465541

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gentle yoga therapy

Procedure

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.

Other names: yoga

counseling intervention

Other

Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.

Other names: counseling and communications studies

Educational Intervention

Other

Undergo enhanced usual care

Other names: intervention, educational

Quality-of-Life Assessment

Other

Ancillary studies

Other names: quality of life assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB).

    Time frame: 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 outcomes

  1. Examine intervention feasibility using a composite assessment.

    Time frame: Up to 14 weeks

    Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate.

Other outcomes

  1. 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

  2. Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ)

    Time frame: Up to 14 weeks

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of a Gentle Yoga Based Exercise Program

Important dates

Study start
2013
Primary completion
2014
Study completion
2022
First posted
Jun 8, 2015
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.