Clinical trial · Interventional
FitEx for Endometrial Cancer Survivors: Initial Efficacy
The Initial Efficacy of FitEx for Endometrial Cancer Survivors: A Pilot Randomized Controlled Trial of a Walking Promotion Program With or Without Yoga
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Obesity | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sedentary Behavior | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group-dynamics | Behavioral | — | UNRESOLVED |
| Newsletters- Standard | Behavioral | — | UNRESOLVED |
| Newsletters- Yoga | Behavioral | — | UNRESOLVED |
| Self-monitoring | Behavioral | — | UNRESOLVED |
| Weekly virtual sessions- Standard | Behavioral | — | UNRESOLVED |
| Weekly virtual sessions- Yoga | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- 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.
- type
- EXPERIMENTAL
- label
- FitEx-ECS
- description
- 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.
- interventionNames
- Behavioral: Self-monitoring
- Behavioral: Group-dynamics
- Behavioral: Weekly virtual sessions- Standard
- Behavioral: Newsletters- Standard
- type
- EXPERIMENTAL
- label
- FitEx-ECS+ Yoga
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available