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

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ClinicalTrials.gov Identifier: NCT02465541
Recruitment Status : Unknown
Verified September 2016 by Brian Focht, Ohio State University Comprehensive Cancer Center.
Recruitment status was:  Recruiting
First Posted : June 8, 2015
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Brian Focht, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Obesity Endometrial Carcinoma Procedure: Gentle yoga therapy Other: counseling intervention Other: educational intervention Other: quality-of-life assessment Other: questionnaire administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : July 2013
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 Name: yoga

Other: counseling intervention
Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
Other Name: counseling and communications studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: questionnaire administration
Ancillary studies

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.
Other: educational intervention
Undergo enhanced usual care
Other Name: intervention, educational

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: questionnaire administration
Ancillary studies




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Change from baseline in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy: General) [ Time Frame: Up to 14 weeks ]
  2. Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ) [ Time Frame: Up to 14 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465541


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Brian Focht, PhD, FACSM 614-293-0757 bfocht@ehe.osu.edu

Locations
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United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Brian C. Focht    614-292-0757    bfocht@ehe.osu.edu   
Principal Investigator: Brian C. Focht         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Brian Focht, PhD, FACSM Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Brian Focht, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02465541     History of Changes
Other Study ID Numbers: OSU-13005
NCI-2014-00770 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Brian Focht, Ohio State University Comprehensive Cancer Center:
Cancer Survivors
Yoga
Endometrial Cancer

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female