FitEx for Endometrial Cancer Survivors: Initial Efficacy
NCT ID: NCT05737745
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2023-02-01
2024-06-20
Brief Summary
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* Do FitEx groups undertake more physical activity than the usual care group?
* Are there differences in quality of life, self-compassion, flourishing, self-efficacy, social support, habit formation, and fruit /vegetable consumption
Participants will:
* Wear a Fitbit
* Complete surveys
* Participate in 30 minute weekly virtual meetings (FitEx groups only)
* Receive weekly newsletters (FitEx groups only)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual care
Endometrial cancer survivors will receive standard survivorship care including a one-time educational newsletter about survivorship physical activity and nutrition recommendations. Fitbits will be given to track physical activity.
No interventions assigned to this group
FitEx-ECS
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS intervention program, with a focus on walking. Fitbits will be given to track physical activity.
Self-monitoring
Tracking physical activity and fruit/vegetable intake.
Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Weekly virtual sessions- Standard
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Newsletters- Standard
Weekly newsletters support attainment of physical activity and nutrition goals.
FitEx-ECS+ Yoga
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.
Self-monitoring
Tracking physical activity and fruit/vegetable intake.
Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Newsletters- Yoga
Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Weekly virtual sessions- Yoga
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
Interventions
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Self-monitoring
Tracking physical activity and fruit/vegetable intake.
Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Weekly virtual sessions- Standard
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Newsletters- Standard
Weekly newsletters support attainment of physical activity and nutrition goals.
Newsletters- Yoga
Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Weekly virtual sessions- Yoga
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with early stage (I-II) endometrial cancer, any histology
* Received cancer care at Carilion Clinic after 1/1/2010
* At least 18 years of age
* Have adequate comprehension (reading and writing) of the English language
* Have a BMI ≥ 30 kg/m\^2 at screening
* Have stable internet access or access to a smartphone with internet capabilities
* Meet the requirements of the Physical Activity Readiness Questionnaire(PARQ)
* Have the capacity to provide informed consent and are willing to provide informed consent
* SUPPORT TEAM--
* Were identified by a participant with endometrial cancer as a member of their support system
* Are at least 18 years of age
* Have adequate comprehension (reading and writing) of the English language
* Have stable internet access or access to a smartphone with internet capabilities
* Meet the requirements of the Physical Activity Readiness Questionnaire (PARQ)
* Have the capacity to provide informed consent and are willing to provide informed consent
Exclusion Criteria
* Recurrent endometrial cancer
* Meeting physical activity guidelines set forth by the American Cancer Society at screening (greater than 150 minutes/week of moderate physical activity, or greater than 75 minutes/week of vigorous physical activity)
* SUPPORT TEAM: Have functional limitations requiring a walker, wheelchair, scooter, or other walking aid which limits their capacity to engage in the intervention safely
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
Virginia Polytechnic Institute and State University
OTHER
Carilion Clinic
OTHER
Responsible Party
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Shannon Armbruster
Principal Investigator
Principal Investigators
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Shannon Armbruster, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Carilion Clinic
Locations
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Carilion Clinic
Roanoke, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB-22-1727
Identifier Type: -
Identifier Source: org_study_id
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