Gentle Yoga and Dietary Counseling in Improving Physical Function and Quality of Life in Stage I-II Endometrial Cancer Survivors
Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of a Gentle Yoga Based Exercise Program
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jul 2013
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2013
CompletedFirst Submitted
Initial submission to the registry
May 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2022
CompletedSeptember 15, 2023
September 1, 2023
11 months
May 16, 2014
September 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 14 weeks
Secondary Outcomes (1)
Examine intervention feasibility using a composite assessment.
Up to 14 weeks
Other Outcomes (2)
Change from baseline in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy: General)
Up to 14 weeks
Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ)
Up to 14 weeks
Study Arms (2)
Arm I (gentle yoga and dietary counseling)
EXPERIMENTALParticipants 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 (enhanced usual care)
ACTIVE COMPARATORParticipants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
Interventions
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.
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
Undergo enhanced usual care
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Focht, PhD, FACSM
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 16, 2014
First Posted
June 8, 2015
Study Start
July 23, 2013
Primary Completion
June 10, 2014
Study Completion
April 27, 2022
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share