FitEx for Endometrial Cancer Survivors: Initial Efficacy

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05737745
• Other study ID #: IRB-22-1727
• Secondary ID: UL1TR003015
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Obesity
• Quality of Life
• Sedentary Behavior
• Survivorship

Intervention

Behavioral:
• Self-monitoring
Tracking physical activity and fruit/vegetable intake.
• Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
• Weekly virtual sessions- Standard
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
• Newsletters- Standard
Weekly newsletters support attainment of physical activity and nutrition goals.
• Newsletters- Yoga
Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
• Weekly virtual sessions- Yoga
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Carilion Clinic	National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)