FitEx for Endometrial Cancer Survivors: Initial Efficacy

Obesity Clinical Trial

Official title: The Initial Efficacy of FitEx for Endometrial Cancer Survivors: A Pilot Randomized Controlled Trial of a Walking Promotion Program With or Without Yoga

Status Active, not recruiting

Clinical Trial 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)

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05737745
• Study type: Interventional
• Source: Carilion Clinic
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Completion date: June 2024