FitEx for Endometrial Cancer Survivors: Initial Efficacy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Cancer, Obesity, Sedentary Behavior, Quality of Life, Survivorship

Intervention / Treatment
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* Behavioral: Self-monitoring
* Behavioral: Group-dynamics
* Behavioral: Weekly virtual sessions- Standard
* Behavioral: Newsletters- Standard
* Behavioral: Newsletters- Yoga
* Behavioral: Weekly virtual sessions- Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Endometrial 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. | |
| Experimental: FitEx-ECS<br>Endometrial 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. | Behavioral: Self-monitoring<br>* Tracking physical activity and fruit/vegetable intake.<br>Behavioral: Group-dynamics<br>* Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.<br>Behavioral: Weekly virtual sessions- Standard<br>* Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.<br>Behavioral: Newsletters- Standard<br>* Weekly newsletters support attainment of physical activity and nutrition goals.<br>|
| Experimental: FitEx-ECS+ Yoga<br>Endometrial 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. | Behavioral: Self-monitoring<br>* Tracking physical activity and fruit/vegetable intake.<br>Behavioral: Group-dynamics<br>* Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.<br>Behavioral: Newsletters- Yoga<br>* Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.<br>Behavioral: Weekly virtual sessions- Yoga<br>* Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |