FitEx for Endometrial Cancer Survivors: Initial Efficacy (NCT05737745) | Clinical Trial Compass
CompletedNot Applicable
FitEx for Endometrial Cancer Survivors: Initial Efficacy
United States111 participantsStarted 2023-02-01
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
Timeframe: Change from baseline to 8 weeks (post-intervention)