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Trial Title:
FitEx for Endometrial Cancer Survivors: Initial Efficacy
NCT ID:
NCT05737745
Condition:
Endometrial Cancer
Obesity
Sedentary Behavior
Quality of Life
Survivorship
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Self-monitoring
Description:
Tracking physical activity and fruit/vegetable intake.
Arm group label:
FitEx-ECS
Arm group label:
FitEx-ECS+ Yoga
Intervention type:
Behavioral
Intervention name:
Group-dynamics
Description:
Survivors act as team captains, facilitating interactions between themselves and their
support team members and providing goal directed feedback.
Arm group label:
FitEx-ECS
Arm group label:
FitEx-ECS+ Yoga
Intervention type:
Behavioral
Intervention name:
Weekly virtual sessions- Standard
Description:
Weekly 30 minute virtual sessions include support group/team building sessions and 15
minutes of physical activity.
Arm group label:
FitEx-ECS
Intervention type:
Behavioral
Intervention name:
Newsletters- Standard
Description:
Weekly newsletters support attainment of physical activity and nutrition goals.
Arm group label:
FitEx-ECS
Intervention type:
Behavioral
Intervention name:
Newsletters- Yoga
Description:
Weekly newsletters support attainment of physical activity and nutrition goals, while
including mindfulness principles.
Arm group label:
FitEx-ECS+ Yoga
Intervention type:
Behavioral
Intervention name:
Weekly virtual sessions- Yoga
Description:
Weekly 30 minute virtual sessions include support group/team building sessions and 15
minutes of yoga.
Arm group label:
FitEx-ECS+ Yoga
Summary:
The goal of this clinical trial is to compare physical activity outcomes between
endometrial cancer survivors randomized to 1 of 3 conditions: 1) usual care, 2) FitEx, 3)
FitEx+yoga. Survivors randomized to FitEx groups will recruit ~3 support team members to
complete the intervention with them. The main question[s] it aims to answer are:
- 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)
Detailed description:
The purpose of this pilot study is to evaluate the initial efficacy of FitEx, a physical
activity tracking and promotion program, and FitEx+yoga for endometrial cancer survivors
(ECS), with focus on improvement of moderate-vigorous physical activity (MVPA) at the
completion of the 8-week program. Specifically, this project will recruit early stage ECS
with obesity to be randomized to 1 of 3 conditions: 1) usual care, 2) FitEx, 3)
FitEx+yoga. ECS in either intervention condition will each select ~3 friends or family
members to be their support members (minimum 2 and maximum 5). All ECS will receive a
Fitbit to track their MVPA. We will then compare secondary ECS outcome measures between
intervention and control groups including quality of life, self-compassion, flourishing,
self-efficacy, social support, habit formation and fruit/vegetable consumption.
Additionally, support team member MVPA (via Fitbit) and secondary outcomes will be
compared. We will also explore long-term MPVA and secondary outcomes in all groups at 6
months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
SURIVIVOR
- 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:
SURVIVOR
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Carilion Clinic
Address:
City:
Roanoke
Zip:
24016
Country:
United States
Start date:
February 1, 2023
Completion date:
June 2024
Lead sponsor:
Agency:
Carilion Clinic
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Center for Advancing Translational Sciences (NCATS)
Agency class:
NIH
Collaborator:
Agency:
Virginia Polytechnic Institute and State University
Agency class:
Other
Source:
Carilion Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737745
