Clinical trial NCT02465541: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Endometrial Carcinoma
Keywords: Cancer Survivors
Yoga
Endometrial Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 16
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB).
timeFrame: Up to 14 weeks
Secondary outcomes:
measure: Examine intervention feasibility using a composite assessment.
timeFrame: Up to 14 weeks
Other outcomes:
measure: Change from baseline in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy: General)
timeFrame: Up to 14 weeks
measure: Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ)
timeFrame: Up to 14 weeks
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brian Focht, PhD, FACSM
role: PRINCIPAL_INVESTIGATOR
References: