NCT05737745

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer
• Obesity
• Sedentary Behavior
• Quality of Life
• Survivorship

Interventions

Type	Name	Description
BEHAVIORAL	Self-monitoring	Tracking physical activity and fruit/vegetable intake.
BEHAVIORAL	Group-dynamics	Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
BEHAVIORAL	Weekly virtual sessions- Standard	Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
BEHAVIORAL	Newsletters- Standard	Weekly newsletters support attainment of physical activity and nutrition goals.
BEHAVIORAL	Newsletters- Yoga	Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
BEHAVIORAL	Weekly virtual sessions- Yoga	Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-11-30
• Completion: 2024-06-20
• First posted: 2023-02-21
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

1 site across 1 country: United States