Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR003015 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| Virginia Polytechnic Institute and State University | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | 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. | |
| FitEx-ECS | Experimental | 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. |
|
| FitEx-ECS+ Yoga | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-monitoring | Behavioral | Tracking physical activity and fruit/vegetable intake. |
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Moderate to Vigorous Physical Activity Maintenance- Support Team Members |
Inclusion Criteria:
SURIVIVOR
Exclusion Criteria:
SURVIVOR
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shannon Armbruster, MD MPH | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic | Roanoke | Virginia | 24016 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Completion of all questions and survey information was not required for study enrollment. Data that was obtained is provided.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | FitEx-ECS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not all participants included a date of birth so age could not be calculated |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Minutes per day of moderate to vigorous physical activity (MVPA) over 7 days was compared from 8 weeks to baseline data. Participants need to have at least 4 days per week of wear time at each time point to be included. | Posted | Mean | Standard Deviation | minutes per day of MVPA | Change from baseline to 8 weeks (post-intervention) |
|
Participants were observed for 10 weeks: one week at baseline, 8 weeks during the study, and one week 6 months after completing the intervention.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Following randomization, 7 participants withdrew from participation due to changes in their ability to attend weekly meetings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shannon Armbruster MD, MPH | Virginia Tech Carilion Clinic | 540-581-0160 | sdarmbruster@carilionclinic.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2024 | Nov 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2023 | Nov 22, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Group-dynamics | Behavioral | Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback. |
|
| Weekly virtual sessions- Standard | Behavioral | Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity. |
|
| Newsletters- Standard | Behavioral | Weekly newsletters support attainment of physical activity and nutrition goals. |
|
| Newsletters- Yoga | Behavioral | Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles. |
|
| Weekly virtual sessions- Yoga | Behavioral | Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga. |
|
| 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) |
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
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. 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. |
| BG002 | 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. 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Not all enrolled participants completed all intake questionnaires. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Not all enrolled participants completed all intake questionnaires. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured. | Count of Participants | Participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. 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. |
|
|
| 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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). | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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). | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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). | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 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) | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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) | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| Other Pre-specified | 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) | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| Other Pre-specified | 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) | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| Other Pre-specified | 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) | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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 | Not Posted | Change from 8 weeks to 6 months (post-intervention) | Participants |
| Other Pre-specified | 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) | Not Posted | Change from baseline to 8 weeks (post-intervention) | Participants |
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. 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. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | 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. 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. 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. | 0 | 57 | 0 | 57 | 0 | 57 |
Not provided
Not provided
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|