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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 10, 2014

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.

Interventions

  • 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.
  • Other: educational intervention
    • Undergo enhanced usual care
  • Other: quality-of-life assessment
    • Ancillary studies
  • Other: questionnaire administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Arm I (gentle yoga and dietary counseling)
    • 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.
  • Active Comparator: Arm II (enhanced usual care)
    • Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Examine intervention feasibility using a composite assessment.
    • Time Frame: Up to 14 weeks
    • Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brian Focht, Principal Investigator – Ohio State University Comprehensive Cancer Center
  • Overall Official(s)
    • Brian Focht, PhD, FACSM, Principal Investigator, Ohio State University Comprehensive Cancer Center

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