FitEx for Endometrial Cancer Survivors: Initial Efficacy
Study Details
Study Description
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:
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Do FitEx groups undertake more physical activity than the usual care group?
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Are there differences in quality of life, self-compassion, flourishing, self-efficacy, social support, habit formation, and fruit /vegetable consumption
Participants will:
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Wear a Fitbit
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Complete surveys
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Participate in 30 minute weekly virtual meetings (FitEx groups only)
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Receive weekly newsletters (FitEx groups only)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual care 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 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
Tracking physical activity and fruit/vegetable intake.
Behavioral: Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Behavioral: Weekly virtual sessions- Standard
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Behavioral: Newsletters- Standard
Weekly newsletters support attainment of physical activity and nutrition goals.
|
| Experimental: FitEx-ECS+ Yoga 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
Tracking physical activity and fruit/vegetable intake.
Behavioral: Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Behavioral: Newsletters- Yoga
Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Behavioral: Weekly virtual sessions- Yoga
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
|
Outcome Measures
Primary Outcome Measures
- Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors [Change from baseline to 8 weeks (post-intervention)]
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)
Secondary Outcome Measures
- Quality of Life- Survivors [Change from baseline to 8 weeks (post-intervention)]
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
- Quality of Life Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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
- Servings of Daily Fruits and Vegetables Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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).
- Servings of Daily Fruits and Vegetables- Survivors [Change from baseline to 8 weeks (post-intervention)]
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).
- Flourishing- Survivors [Change from baseline to 8 weeks (post-intervention)]
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
- Flourishing Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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
- Yoga Self-Efficacy- Survivors [Change from baseline to 8 weeks (post-intervention)]
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
- Yoga Self-Efficacy Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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
- Social Support- Survivors [Change from baseline to 8 weeks (post-intervention)]
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
- Social Support Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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
- Self-compassion- Survivors [Change from baseline to 8 weeks (post-intervention)]
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
- Self-compassion Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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
- Habit Formation- Survivors [Change from baseline to 8 weeks (post-intervention)]
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
- Habit Formation Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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
- Physical activity level (active or insufficiently active) Maintenance- Survivors [Change from 8 weeks to 6 months (post-intervention)]
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).
- Physical activity level (active or insufficiently active)- Survivors [Change from baseline to 8 weeks (post-intervention)]
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
- Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance [Change from 8 weeks to 6 months (post-intervention)]
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)
Other Outcome Measures
- Moderate to Vigorous Physical Activity- Support team members [Change from baseline to 8 weeks (post-intervention)]
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
- Moderate to Vigorous Physical Activity Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
- Flourishing- Support team members [Change from baseline to 8 weeks (post-intervention)]
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
- Flourishing Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
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
- Yoga Self-Efficacy- Support team members [Change from baseline to 8 weeks (post-intervention)]
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
- Yoga Self-Efficacy Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
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
- Social Support- Support team members [Change from baseline to 8 weeks (post-intervention)]
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
- Social Support Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
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
- Self-compassion- Support team members [Change from baseline to 8 weeks (post-intervention)]
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
- Self-compassion Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
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
- Habit Formation- Support team members [Change from baseline to 8 weeks (post-intervention)]
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
- Physical activity level (active or insufficiently active)- Support team members [Change from baseline to 8 weeks (post-intervention)]
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)
- Physical activity level (active or insufficiently active) Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
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)
- Habit Formation Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
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
- Servings of Daily Fruits and Vegetables- Support team members [Change from baseline to 8 weeks (post-intervention)]
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)
- Servings of Daily Fruits and Vegetables Maintenance- Support team members [Change from 8 weeks to 6 months (post-intervention)]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
SURIVIVOR
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Diagnosed with early stage (I-II) endometrial cancer, any histology
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Received cancer care at Carilion Clinic after 1/1/2010
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At least 18 years of age
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Have adequate comprehension (reading and writing) of the English language
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Have a BMI ≥ 30 kg/m^2 at screening
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Have stable internet access or access to a smartphone with internet capabilities
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Meet the requirements of the Physical Activity Readiness Questionnaire(PARQ)
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Have the capacity to provide informed consent and are willing to provide informed consent
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SUPPORT TEAM--
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Were identified by a participant with endometrial cancer as a member of their support system
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Are at least 18 years of age
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Have adequate comprehension (reading and writing) of the English language
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Have stable internet access or access to a smartphone with internet capabilities
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Meet the requirements of the Physical Activity Readiness Questionnaire (PARQ)
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Have the capacity to provide informed consent and are willing to provide informed consent
Exclusion Criteria:
SURVIVOR
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Recurrent endometrial cancer
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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)
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SUPPORT TEAM: Have functional limitations requiring a walker, wheelchair, scooter, or other walking aid which limits their capacity to engage in the intervention safely
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carilion Clinic | Roanoke | Virginia | United States | 24016 |
Sponsors and Collaborators
- Carilion Clinic
- National Institutes of Health (NIH)
- National Center for Advancing Translational Sciences (NCATS)
- Virginia Polytechnic Institute and State University
Investigators
- Principal Investigator: Shannon Armbruster, MD MPH, Carilion Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-22-1727
- UL1TR003015