FitEx for Endometrial Cancer Survivors: Initial Efficacy

Carilion Clinic111 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Interventions

Self-monitoringBEHAVIORAL

Tracking physical activity and fruit/vegetable intake.

Group-dynamicsBEHAVIORAL

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

Weekly virtual sessions- StandardBEHAVIORAL

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

Newsletters- StandardBEHAVIORAL

Weekly newsletters support attainment of physical activity and nutrition goals.

Newsletters- YogaBEHAVIORAL

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

Weekly virtual sessions- YogaBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

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

Time frame: 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

Time frame: 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).

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

Servings of Daily Fruits and Vegetables- Survivors

Time frame: 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

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

Flourishing Maintenance- Survivors

Time frame: 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

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

Yoga Self-Efficacy Maintenance- Survivors

Time frame: 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

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

Social Support Maintenance- Survivors

Time frame: 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

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

Self-compassion Maintenance- Survivors

Time frame: 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

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

Habit Formation Maintenance- Survivors

Time frame: 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).

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

Physical Activity Level (Active or Insufficiently Active)- Survivors

Time frame: 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)

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

FitEx for Endometrial Cancer Survivors: Initial Efficacy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes