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Endometrial CancerNCT05737745

FitEx for Endometrial Cancer Survivors: Initial Efficacy

A study testing Self-monitoring, Group-dynamics and Weekly virtual sessions- Standard in people with Endometrial Cancer and Obesity, run by Carilion Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endometrial Cancer, Obesity, Sedentary Behavior
What is being tested?
Self-monitoring, Group-dynamics and Weekly virtual sessions- Standard
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteUnited States
Study dates
1 Feb 2023to 20 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Carilion Clinic

    Roanoke, Virginia, 24016

Other trials in United States

About this study

Official title: 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
Read more

Participants will:

  • Wear a Fitbit
  • Complete surveys
  • Participate in 30 minute weekly virtual meetings (FitEx groups only)
  • Receive weekly newsletters (FitEx groups only)
Read the 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.

Being tested
Self-monitoring, Group-dynamics, Weekly virtual sessions- Standard, Newsletters- Standard, Newsletters- Yoga
Medical subject headings
Endometrial Neoplasms, Obesity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-monitoringBehavioural

    Tracking physical activity and fruit/vegetable intake.

  • Group-dynamicsBehavioural

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

  • Weekly virtual sessions- StandardBehavioural

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

  • Newsletters- StandardBehavioural

    Weekly newsletters support attainment of physical activity and nutrition goals.

  • Newsletters- YogaBehavioural

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

  • Weekly virtual sessions- YogaBehavioural

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

Study groups in NCT05737745
Study groupRoleWhat they receive
Usual careNo interventionEndometrial 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-ECSExperimentalEndometrial 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.
Receives: Behavioral: Self-monitoring; Behavioral: Group-dynamics; Behavioral: Weekly virtual sessions- Standard; Behavioral: Newsletters- Standard
FitEx-ECS+ YogaExperimentalEndometrial 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.
Receives: Behavioral: Self-monitoring; Behavioral: Group-dynamics; Behavioral: Newsletters- Yoga; Behavioral: Weekly virtual sessions- Yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (17)
  1. 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

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

  2. 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

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

  3. 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).

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

  4. 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).

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

  5. 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

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

  6. 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

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

  7. 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

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

  8. 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

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

  9. 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

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

  10. 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

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

  11. 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

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

  12. 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

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

  13. 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

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

  14. 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

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

  15. 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).

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

  16. 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

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

  17. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start1 Feb 2023
  3. Primary completion30 Nov 2023
  4. Study completion20 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737745
Sponsor's protocol ID
IRB-22-1727
Other IDs
UL1TR003015
Status last verified
Apr 2025
First submitted
1 Feb 2023
Last updated
9 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-monitoring, Group-dynamics and Weekly virtual sessions- Standard in people with Endometrial Cancer and Obesity, run by Carilion Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors (time frame: Change from baseline to 8 weeks (post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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