N/A
N=111
FitEx for Endometrial Cancer Survivors: Initial Efficacy
Endometrial Cancer · Obesity · Sedentary Behavior · Quality of Life · Survivorship
Bottom Line
View on ClinicalTrials.gov: NCT05737745 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors — 3.7; 12.14; 3.15 minutes per day of MVPA
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-monitoring (Behavioral); Group-dynamics (Behavioral); Weekly virtual sessions- Standard (Behavioral); Newsletters- Standard (Behavioral); Newsletters- Yoga (Behavioral); Weekly virtual sessions- Yoga (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Carilion Clinic
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors |
3.7; 12.14; 3.15 | — |
| SECONDARY Quality of Life- Survivors |
— | — |
| SECONDARY Quality of Life Maintenance- Survivors |
— | — |
| SECONDARY Servings of Daily Fruits and Vegetables Maintenance- Survivors |
— | — |
| SECONDARY Servings of Daily Fruits and Vegetables- Survivors |
— | — |
| SECONDARY Flourishing- Survivors |
— | — |
| SECONDARY Flourishing Maintenance- Survivors |
— | — |
| SECONDARY Yoga Self-Efficacy- Survivors |
— | — |
| SECONDARY Yoga Self-Efficacy Maintenance- Survivors |
— | — |
| SECONDARY Social Support- Survivors |
— | — |
| SECONDARY Social Support Maintenance- Survivors |
— | — |
| SECONDARY Self-compassion- Survivors |
— | — |
| SECONDARY Self-compassion Maintenance- Survivors |
— | — |
| SECONDARY Habit Formation- Survivors |
— | — |
| SECONDARY Habit Formation Maintenance- Survivors |
— | — |
| SECONDARY Physical Activity Level (Active or Insufficiently Active) Maintenance- Survivors |
— | — |
| SECONDARY Physical Activity Level (Active or Insufficiently Active)- Survivors |
— | — |
| SECONDARY Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance |
— | — |
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)
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
Data sourced from ClinicalTrials.gov (NCT05737745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.