FitEx for Endometrial Cancer Survivors: Initial Efficacy

Not Applicable

Completed

Conditions: Endometrial Cancer
Sedentary Behavior
Obesity
Quality of Life
Survivorship

Registration Number: NCT05737745

Lead Sponsor: Carilion Clinic

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)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 111

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors	Change from baseline to 8 weeks (post-intervention)	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)

Secondary Outcome Measures

Name	Time	Method
Physical Activity Level (Active or Insufficiently Active)- Survivors	Change from baseline to 8 weeks (post-intervention)	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
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance	Change from 8 weeks to 6 months (post-intervention)	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)
Quality of Life- Survivors	Change from baseline to 8 weeks (post-intervention)	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
Quality of Life Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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
Servings of Daily Fruits and Vegetables Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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).
Servings of Daily Fruits and Vegetables- Survivors	Change from baseline to 8 weeks (post-intervention)	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).
Flourishing- Survivors	Change from baseline to 8 weeks (post-intervention)	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
Flourishing Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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
Yoga Self-Efficacy- Survivors	Change from baseline to 8 weeks (post-intervention)	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
Yoga Self-Efficacy Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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
Social Support- Survivors	Change from baseline to 8 weeks (post-intervention)	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
Social Support Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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
Self-compassion- Survivors	Change from baseline to 8 weeks (post-intervention)	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
Self-compassion Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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
Habit Formation- Survivors	Change from baseline to 8 weeks (post-intervention)	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
Habit Formation Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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
Physical Activity Level (Active or Insufficiently Active) Maintenance- Survivors	Change from 8 weeks to 6 months (post-intervention)	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).