ObesityNCT02465541
Gentle Yoga and Dietary Counseling in Improving Physical Function and Quality of Life in Stage I-II Endometrial Cancer Survivors
A study testing Gentle yoga therapy, counseling intervention and educational intervention in people with Obesity and Endometrial Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity, Endometrial Carcinoma
- What is being tested?
- Gentle yoga therapy, counseling intervention and educational intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2013to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Obesity, Endometrial Carcinoma
- Being tested
- Gentle yoga therapy, counseling intervention, educational intervention, quality-of-life assessment, questionnaire administration
- Keywords
- Cancer Survivors, Yoga, Endometrial Cancer
- Medical subject headings
- Obesity, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle yoga therapyProcedure or surgery
Also called yoga
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.
counseling interventionOther
Also called counseling and communications studies
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
educational interventionOther
Also called intervention, educational
Undergo enhanced usual care
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (gentle yoga and dietary counseling) | Experimental | 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. Receives: Procedure: Gentle yoga therapy; Other: counseling intervention; Other: quality-of-life assessment; Other: questionnaire administration |
| Arm II (enhanced usual care) | Active comparator | Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks. Receives: Other: educational intervention; Other: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 weeks
Secondary outcomes (1)
Examine intervention feasibility using a composite assessment.
Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start23 Jul 2013
- Primary completion10 Jun 2014
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Focht, Ohio State University Comprehensive Cancer Center
- Investigators
- Brian Focht, PhD, FACSM, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465541
- Sponsor's protocol ID
- OSU-13005
- Other IDs
- NCI-2014-00770
- Status last verified
- Sep 2023
- First submitted
- 16 May 2014
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02465541
- Acronym / sponsor ID
- OSU-13005
- Conditions
- Obesity, Endometrial Carcinoma
- Keywords
- Cancer Survivors, Yoga, Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- 10 Jun 2014 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (gentle yoga and dietary counseling) | Experimental | Procedure: Gentle yoga therapy, Other: counseling intervention, Other: quality-of-life assessment, Other: questionnaire administrationParticipants 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 comparator | Other: educational intervention, Other: quality-of-life assessment, Other: questionnaire administrationParticipants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentle yoga therapyAlso: yogaMindfulness 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. | Procedure or surgery | Arm I (gentle yoga and dietary counseling) |
| counseling interventionAlso: counseling and communications studiesUndergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian. | Other | Arm I (gentle yoga and dietary counseling) |
| educational interventionAlso: intervention, educationalUndergo enhanced usual care | Other | Arm II (enhanced usual care) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (gentle yoga and dietary counseling), Arm II (enhanced usual care) |
| questionnaire administrationAncillary studies | Other | Arm I (gentle yoga and dietary counseling), Arm II (enhanced usual care) |
Primary outcome
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.
1 secondary outcome
Examine intervention feasibility using a composite assessment.
Time frame: Up to 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Focht, PhD, FACSM principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle yoga therapy, counseling intervention and educational intervention in people with Obesity and Endometrial Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB). (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.