Clinical trial NCT05737745: FitEx for Endometrial Cancer Survivors: Initial Efficacy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Obesity
Sedentary Behavior
Quality of Life
Survivorship
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
name: Virginia Polytechnic Institute and State University
First posted: 2023-02-21
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
Secondary outcomes:
measure: Quality of Life- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Quality of Life Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Servings of Daily Fruits and Vegetables Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Servings of Daily Fruits and Vegetables- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Flourishing- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Flourishing Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Yoga Self-Efficacy- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Yoga Self-Efficacy Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Social Support- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Social Support Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Self-compassion- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Self-compassion Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Habit Formation- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Habit Formation Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Physical Activity Level (Active or Insufficiently Active) Maintenance- Survivors
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Physical Activity Level (Active or Insufficiently Active)- Survivors
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance
timeFrame: Change from 8 weeks to 6 months (post-intervention)
Other outcomes:
measure: Moderate to Vigorous Physical Activity- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Moderate to Vigorous Physical Activity Maintenance- Support Team Members
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Flourishing- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Flourishing Maintenance- Support Team Members
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Yoga Self-Efficacy- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Yoga Self-Efficacy Maintenance- Support Team Members
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Social Support- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Social Support Maintenance- Support Team Members
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Self-compassion- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Self-compassion Maintenance- Support Team Members
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Habit Formation- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Physical Activity Level (Active or Insufficiently Active)- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Physical Activity Level (Active or Insufficiently Active) Maintenance- Support Team Members
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Habit Formation Maintenance- Support Team Members
timeFrame: Change from 8 weeks to 6 months (post-intervention)
measure: Servings of Daily Fruits and Vegetables- Support Team Members
timeFrame: Change from baseline to 8 weeks (post-intervention)
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Shannon Armbruster, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: