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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465541
• Other study ID #: OSU-13005
• Secondary ID: NCI-2014-00770
• Status: Completed
• Phase: N/A
• Start date: July 23, 2013
• Est. completion date: April 27, 2022

Study information

• Verified date: September 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 27, 2022
• Est. primary completion date: June 10, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Carcinoma
• Endometrial Neoplasms
• Obesity

Intervention

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:
• counseling intervention
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
• educational intervention
Undergo enhanced usual care
• quality-of-life assessment
Ancillary studies
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy: General)		Up to 14 weeks
Other	Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ)		Up to 14 weeks
Primary	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	Examine intervention feasibility using a composite assessment.	Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate.	Up to 14 weeks

External Links

•   The Jamesline