Back to resultsFitEx for Endometrial Cancer Survivors: Initial Efficacy
Primary Purpose
Endometrial Cancer, Obesity, Sedentary Behavior
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-monitoring
Group-dynamics
Weekly virtual sessions- Standard
Newsletters- Standard
Newsletters- Yoga
Weekly virtual sessions- Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Endometrial Cancer
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
Sites / Locations
- Carilion Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Usual care
FitEx-ECS
FitEx-ECS+ Yoga
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
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).
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).
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
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
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
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
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
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
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
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
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
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
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).
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
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)
Full Information
NCT ID
NCT05737745
First Posted
February 1, 2023
Last Updated
February 20, 2023
Sponsor
Carilion Clinic
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), Virginia Polytechnic Institute and State University
1. Study Identification
Unique Protocol Identification Number
NCT05737745
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), Virginia Polytechnic Institute and State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Obesity, Sedentary Behavior, Quality of Life, Survivorship
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Arm Title
FitEx-ECS
Arm Type
Experimental
Arm Description
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.
Arm Title
FitEx-ECS+ Yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring
Intervention Description
Tracking physical activity and fruit/vegetable intake.
Intervention Type
Behavioral
Intervention Name(s)
Group-dynamics
Intervention Description
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Intervention Type
Behavioral
Intervention Name(s)
Weekly virtual sessions- Standard
Intervention Description
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Newsletters- Standard
Intervention Description
Weekly newsletters support attainment of physical activity and nutrition goals.
Intervention Type
Behavioral
Intervention Name(s)
Newsletters- Yoga
Intervention Description
Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Intervention Type
Behavioral
Intervention Name(s)
Weekly virtual sessions- Yoga
Intervention Description
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
Primary Outcome Measure Information:
Title
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
Description
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 Outcome Measure Information:
Title
Quality of Life- Survivors
Description
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)
Title
Quality of Life Maintenance- Survivors
Description
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)
Title
Servings of Daily Fruits and Vegetables Maintenance- Survivors
Description
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)
Title
Servings of Daily Fruits and Vegetables- Survivors
Description
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 baseline to 8 weeks (post-intervention)
Title
Flourishing- Survivors
Description
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)
Title
Flourishing Maintenance- Survivors
Description
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 8 weeks to 6 months (post-intervention)
Title
Yoga Self-Efficacy- Survivors
Description
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)
Title
Yoga Self-Efficacy Maintenance- Survivors
Description
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 8 weeks to 6 months (post-intervention)
Title
Social Support- Survivors
Description
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)
Title
Social Support Maintenance- Survivors
Description
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 8 weeks to 6 months (post-intervention)
Title
Self-compassion- Survivors
Description
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)
Title
Self-compassion Maintenance- Survivors
Description
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 8 weeks to 6 months (post-intervention)
Title
Habit Formation- Survivors
Description
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)
Title
Habit Formation Maintenance- Survivors
Description
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 8 weeks to 6 months (post-intervention)
Title
Physical activity level (active or insufficiently active) Maintenance- Survivors
Description
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)
Title
Physical activity level (active or insufficiently active)- Survivors
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance
Description
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)
Other Pre-specified Outcome Measures:
Title
Moderate to Vigorous Physical Activity- Support team members
Description
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Moderate to Vigorous Physical Activity Maintenance- Support team members
Description
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Time Frame
Change from 8 weeks to 6 months (post-intervention)
Title
Flourishing- Support team members
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Flourishing Maintenance- Support team members
Description
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
Time Frame
Change from 8 weeks to 6 months (post-intervention)
Title
Yoga Self-Efficacy- Support team members
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Yoga Self-Efficacy Maintenance- Support team members
Description
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
Time Frame
Change from 8 weeks to 6 months (post-intervention)
Title
Social Support- Support team members
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Social Support Maintenance- Support team members
Description
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
Time Frame
Change from 8 weeks to 6 months (post-intervention)
Title
Self-compassion- Support team members
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Self-compassion Maintenance- Support team members
Description
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
Time Frame
Change from 8 weeks to 6 months (post-intervention)
Title
Habit Formation- Support team members
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Physical activity level (active or insufficiently active)- Support team members
Description
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)
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Physical activity level (active or insufficiently active) Maintenance- Support team members
Description
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)
Time Frame
Change from 8 weeks to 6 months (post-intervention)
Title
Habit Formation Maintenance- Support team members
Description
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
Time Frame
Change from 8 weeks to 6 months (post-intervention)
Title
Servings of Daily Fruits and Vegetables- Support team members
Description
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)
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Servings of Daily Fruits and Vegetables Maintenance- Support team members
Description
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)
Time Frame
Change from 8 weeks to 6 months (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Mitchell
Phone
540-521-1355
Email
dmmitchell@carilionclinic.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Cooper
Phone
540-797-9789
Email
kecooper1@carilionclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Armbruster, MD MPH
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Cooper
Email
kecooper1@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Shannon D Armbruster, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FitEx for Endometrial Cancer Survivors: Initial Efficacy
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