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

Primary Purpose

Obesity, Endometrial Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gentle yoga therapy
counseling intervention
educational intervention
quality-of-life assessment
questionnaire administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Cancer Survivors, Yoga, Endometrial Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (gentle yoga and dietary counseling)

Arm II (enhanced usual care)

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Examine intervention feasibility using a composite assessment.
Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate.

Full Information

First Posted
May 16, 2014
Last Updated
September 14, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02465541
Brief Title
Gentle Yoga and Dietary Counseling in Improving Physical Function and Quality of Life in Stage I-II Endometrial Cancer Survivors
Official Title
Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of a Gentle Yoga Based Exercise Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 23, 2013 (Actual)
Primary Completion Date
June 10, 2014 (Actual)
Study Completion Date
April 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Endometrial Carcinoma
Keywords
Cancer Survivors, Yoga, Endometrial Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (gentle yoga and dietary counseling)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (enhanced usual care)
Arm Type
Active Comparator
Arm Description
Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
Intervention Type
Procedure
Intervention Name(s)
Gentle yoga therapy
Other Intervention Name(s)
yoga
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
counseling intervention
Other Intervention Name(s)
counseling and communications studies
Intervention Description
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Undergo enhanced usual care
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB).
Description
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.
Time Frame
Up to 14 weeks
Secondary Outcome Measure Information:
Title
Examine intervention feasibility using a composite assessment.
Description
Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate.
Time Frame
Up to 14 weeks
Other Pre-specified Outcome Measures:
Title
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
Title
Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ)
Time Frame
Up to 14 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Focht, PhD, FACSM
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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