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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Obesity; Endometrial Cancer; Sedentary Behavior; Survivorship
• Intervention / Treatment: Behavioral: Self-monitoring; Behavioral: Group-dynamics; Behavioral: Weekly virtual sessions- Standard; Behavioral: Newsletters- Standard; Behavioral: Newsletters- Yoga; Behavioral: Weekly virtual sessions- Yoga

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Mitchell; Phone Number: 540-521-1355; Email: dmmitchell@carilionclinic.org
• Study Contact Backup: Name: Kristina Cooper; Phone Number: 540-797-9789; Email: kecooper1@carilionclinic.org

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic
      • Contact: Kristina Cooper; Email: kecooper1@carilionclinic.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; 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.
Experimental: FitEx-ECS; 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; 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.
Experimental: FitEx-ECS+ Yoga; 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; 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life- Survivors	Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy - Endometrial (FACT-En)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life	Change from baseline to 8 weeks (post-intervention)
Servings of Daily Fruits and Vegetables Maintenance- Survivors	Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).	Change from 8 weeks to 6 months (post-intervention)
Servings of Daily Fruits and Vegetables- Survivors	Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).	Change from baseline to 8 weeks (post-intervention)
Flourishing- Survivors	Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: 0-10, with higher scores indication more satisfaction/flourishing	Change from baseline to 8 weeks (post-intervention)
Yoga Self-Efficacy- Survivors	Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (12-108) higher scores indicate higher efficacy for yoga	Change from baseline to 8 weeks (post-intervention)
Social Support- Survivors	Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: higher numbers indicate more support	Change from baseline to 8 weeks (post-intervention)
Self-compassion- Survivors	Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (1, 5) with higher scores indicating more self-compassion	Change from baseline to 8 weeks (post-intervention)
Habit Formation- Survivors	Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring (1,7), higher scores indicate more automaticity/habit formation	Change from baseline to 8 weeks (post-intervention)
Physical activity level (active or insufficiently active) Maintenance- Survivors	Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).	Change from 8 weeks to 6 months (post-intervention)
Physical activity level (active or insufficiently active)- Survivors	Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: responses are categorical	Change from baseline to 8 weeks (post-intervention)
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance	Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)	Change from 8 weeks to 6 months (post-intervention)
Quality of Life Maintenance- Survivors	Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy - Endometrial) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life	Change from 8 weeks to 6 months (post-intervention)
Flourishing Maintenance- Survivors	Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: 0-10, with higher scores indication more satisfaction/flourishing	Change from 8 weeks to 6 months (post-intervention)
Yoga Self-Efficacy Maintenance- Survivors	Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (12-108) higher scores indicate higher efficacy for yoga	Change from 8 weeks to 6 months (post-intervention)
Social Support Maintenance- Survivors	Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: higher numbers indicate more support	Change from 8 weeks to 6 months (post-intervention)
Self-compassion Maintenance- Survivors	Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (1, 5) with higher scores indicating more self-compassion	Change from 8 weeks to 6 months (post-intervention)
Habit Formation Maintenance- Survivors	Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring (1,7), higher scores indicate more automaticity/habit formation	Change from 8 weeks to 6 months (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate to Vigorous Physical Activity- Support team members	Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)	Change from baseline to 8 weeks (post-intervention)
Moderate to Vigorous Physical Activity Maintenance- Support team members	Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)	Change from 8 weeks to 6 months (post-intervention)
Physical activity level (active or insufficiently active)- Support team members	Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)	Change from baseline to 8 weeks (post-intervention)
Physical activity level (active or insufficiently active) Maintenance- Support team members	Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)	Change from 8 weeks to 6 months (post-intervention)
Servings of Daily Fruits and Vegetables- Support team members	Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)	Change from baseline to 8 weeks (post-intervention)
Servings of Daily Fruits and Vegetables Maintenance- Support team members	Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)	Change from 8 weeks to 6 months (post-intervention)
Flourishing- Support team members	Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing	Change from baseline to 8 weeks (post-intervention)
Flourishing Maintenance- Support team members	Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing	Change from 8 weeks to 6 months (post-intervention)
Yoga Self-Efficacy- Support team members	Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga	Change from baseline to 8 weeks (post-intervention)
Yoga Self-Efficacy Maintenance- Support team members	Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga	Change from 8 weeks to 6 months (post-intervention)
Social Support- Support team members	Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support	Change from baseline to 8 weeks (post-intervention)
Social Support Maintenance- Support team members	Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support	Change from 8 weeks to 6 months (post-intervention)
Self-compassion- Support team members	Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion	Change from baseline to 8 weeks (post-intervention)
Self-compassion Maintenance- Support team members	Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion	Change from 8 weeks to 6 months (post-intervention)
Habit Formation- Support team members	Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation	Change from baseline to 8 weeks (post-intervention)
Habit Formation Maintenance- Support team members	Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation	Change from 8 weeks to 6 months (post-intervention)

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Collaborators: National Institutes of Health (NIH); Virginia Polytechnic Institute and State University; National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Shannon Armbruster, MD MPH, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: IRB-22-1727; UL1TR003015 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No