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Completed

NCT Number: NCT05737745

FitEx for Endometrial Cancer Survivors: Initial Efficacy

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)

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Key information

Conditions

Endometrial Cancer Behavior Body Weight Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Quality of Life Sedentary Behavior Signs and Symptoms Survivorship Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carilion Clinic

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-monitoring

Behavioral

Tracking physical activity and fruit/vegetable intake.

Group-dynamics

Behavioral

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

Weekly virtual sessions- Standard

Behavioral

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

Newsletters- Standard

Behavioral

Weekly newsletters support attainment of physical activity and nutrition goals.

Newsletters- Yoga

Behavioral

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

Weekly virtual sessions- Yoga

Behavioral

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

Primary outcomes

  1. Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors

    Time frame: 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 outcomes

  1. Quality of Life- Survivors

    Time frame: 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

  2. Quality of Life Maintenance- Survivors

    Time frame: 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

  3. Servings of Daily Fruits and Vegetables Maintenance- Survivors

    Time frame: 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).

  4. Servings of Daily Fruits and Vegetables- Survivors

    Time frame: 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).

  5. Flourishing- Survivors

    Time frame: 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

  6. Flourishing Maintenance- Survivors

    Time frame: 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

  7. Yoga Self-Efficacy- Survivors

    Time frame: 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

  8. Yoga Self-Efficacy Maintenance- Survivors

    Time frame: 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

  9. Social Support- Survivors

    Time frame: 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

  10. Social Support Maintenance- Survivors

    Time frame: 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

  11. Self-compassion- Survivors

    Time frame: 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

  12. Self-compassion Maintenance- Survivors

    Time frame: 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

  13. Habit Formation- Survivors

    Time frame: 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

  14. Habit Formation Maintenance- Survivors

    Time frame: 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

  15. Physical Activity Level (Active or Insufficiently Active) Maintenance- Survivors

    Time frame: 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).

  16. Physical Activity Level (Active or Insufficiently Active)- Survivors

    Time frame: 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

  17. Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance

    Time frame: 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)

Other outcomes

  1. Moderate to Vigorous Physical Activity- Support Team Members

    Time frame: Change from baseline to 8 weeks (post-intervention)

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

  2. Moderate to Vigorous Physical Activity Maintenance- Support Team Members

    Time frame: 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 (FitEx-ECS vs. FitEx-ECS+yoga)

  3. Flourishing- Support Team Members

    Time frame: Change from baseline to 8 weeks (post-intervention)

    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

  4. Flourishing Maintenance- Support Team Members

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

    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

  5. Yoga Self-Efficacy- Support Team Members

    Time frame: Change from baseline to 8 weeks (post-intervention)

    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

  6. Yoga Self-Efficacy Maintenance- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga

  7. Social Support- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support

  8. Social Support Maintenance- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support

  9. Self-compassion- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion

  10. Self-compassion Maintenance- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion

  11. Habit Formation- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation

  12. Physical Activity Level (Active or Insufficiently Active)- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga)

  13. Physical Activity Level (Active or Insufficiently Active) Maintenance- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga)

  14. Habit Formation Maintenance- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation

  15. Servings of Daily Fruits and Vegetables- Support Team Members

    Time frame: 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 groups (FitEx-ECS vs. FitEx-ECS+yoga)

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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