FitEx for Endometrial Cancer Survivors: Initial Efficacy

NCT05737745 | Completed Results

• 2 other identifiers: IRB-22-1727UL1TR003015
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors

  Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits (continuous tracking) between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)

  Change from baseline to 8 weeks (post-intervention)

Secondary Outcomes (17)

• Quality of Life- Survivors

  Change from baseline to 8 weeks (post-intervention)

• Quality of Life Maintenance- Survivors

  Change from 8 weeks to 6 months (post-intervention)

• Servings of Daily Fruits and Vegetables Maintenance- Survivors

  Change from 8 weeks to 6 months (post-intervention)

• Servings of Daily Fruits and Vegetables- Survivors

  Change from baseline to 8 weeks (post-intervention)

• Flourishing- Survivors

  Change from baseline to 8 weeks (post-intervention)

Other Outcomes (15)

• Moderate to Vigorous Physical Activity- Support Team Members

  Change from baseline to 8 weeks (post-intervention)

• Moderate to Vigorous Physical Activity Maintenance- Support Team Members

  Change from 8 weeks to 6 months (post-intervention)

• Flourishing- Support Team Members

  Change from baseline to 8 weeks (post-intervention)

Study Arms (3)

Usual care

NO INTERVENTION

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.

FitEx-ECS

EXPERIMENTAL

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.

Behavioral: Self-monitoring; Behavioral: Group-dynamics; Behavioral: Weekly virtual sessions- Standard; Behavioral: Newsletters- Standard

FitEx-ECS+ Yoga

EXPERIMENTAL

Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.

Behavioral: Self-monitoring; Behavioral: Group-dynamics; Behavioral: Newsletters- Yoga; Behavioral: Weekly virtual sessions- Yoga

Interventions

Self-monitoring BEHAVIORAL

Tracking physical activity and fruit/vegetable intake.

FitEx-ECS; FitEx-ECS+ Yoga

Group-dynamics BEHAVIORAL

Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.

FitEx-ECS; FitEx-ECS+ Yoga

Weekly virtual sessions- Standard BEHAVIORAL

Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.

FitEx-ECS

Newsletters- Standard BEHAVIORAL

Weekly newsletters support attainment of physical activity and nutrition goals.

FitEx-ECS

Newsletters- Yoga BEHAVIORAL

Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.

FitEx-ECS+ Yoga

Weekly virtual sessions- Yoga BEHAVIORAL

Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.

FitEx-ECS+ Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Obesity; Sedentary Behavior

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Limitations and Caveats

Following randomization, 7 participants withdrew from participation due to changes in their ability to attend weekly meetings.

Results Point of Contact

• Title: Shannon Armbruster MD, MPH
• Organization: Virginia Tech Carilion Clinic

sdarmbruster@carilionclinic.org

540-581-0160

Study Officials

• Shannon Armbruster, MD MPH

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 21, 2023
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: June 20, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)