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

September 14, 2023 updated by: Brian Focht, Ohio State University Comprehensive Cancer Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (gentle yoga and dietary counseling)
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.
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Procedure: Gentle yoga therapy
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
Other: counseling intervention
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
Other Names:
  • counseling and communications studies
Active Comparator: Arm II (enhanced usual care)
Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Other: educational intervention
Undergo enhanced usual care
Other Names:
  • intervention, educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 14 weeks

Other Outcome Measures

Outcome Measure
Time Frame
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
Up to 14 weeks
Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ)
Time Frame: Up to 14 weeks
Up to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2013

Primary Completion (Actual)

June 10, 2014

Study Completion (Actual)

April 27, 2022

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimated)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-13005
  • NCI-2014-00770 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on questionnaire administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe