FitEx for Endometrial Cancer Survivors: Initial Efficacy

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)

Conditions

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

Interventions

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Virginia Polytechnic Institute and State University

  collaborator OTHER

• Carilion Clinic

  lead OTHER

Principal Investigators

• Shannon Armbruster, MD MPH · Carilion Clinic

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2023-11-30

Completion

2024-06-20

Countries

• United States

Study Locations