Endometrial Cancer, Obesity, Quality of Life, Sedentary Behavior, Survivorship
Conditions
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.
Interventions
BEHAVIORALSelf-monitoring
Tracking physical activity and fruit/vegetable intake.
BEHAVIORALGroup-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
BEHAVIORALWeekly virtual sessions- Standard
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
BEHAVIORALNewsletters- Standard
Weekly newsletters support attainment of physical activity and nutrition goals.
BEHAVIORALNewsletters- Yoga
Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
BEHAVIORALWeekly virtual sessions- Yoga
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
Sponsors
National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Virginia Polytechnic Institute and State University
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 29 |
| 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. | 57 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 6 | 1 |
Baseline characteristics
| Characteristic | Usual Care | FitEx-ECS | FitEx-ECS+ Yoga | Total |
|---|---|---|---|---|
| Age, Continuous | 58 years | 55 years | 55.6 years | 55.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 20 Participants | 48 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 6 Participants | 8 Participants | 32 Participants |
| Race (NIH/OMB) White | 0 Participants | 23 Participants | 47 Participants | 70 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 41 Participants | 77 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 29 | 0 / 57 |
| other Total, other adverse events | 0 / 18 | 0 / 29 | 0 / 57 |
| serious Total, serious adverse events | 0 / 18 | 0 / 29 | 0 / 57 |
Outcome results
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)
Time frame: Change from baseline to 8 weeks (post-intervention)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors | 3.7 minutes per day of MVPA | Standard Deviation 26.4 |
| FitEx-ECS | Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors | 12.14 minutes per day of MVPA | Standard Deviation 40.75 |
| FitEx-ECS+ Yoga | Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors | 3.15 minutes per day of MVPA | Standard Deviation 25.5 |
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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)
Time frame: Change from 8 weeks to 6 months (post-intervention)
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).
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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).
Time frame: Change from 8 weeks to 6 months (post-intervention)
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).
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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)
Time frame: Change from 8 weeks to 6 months (post-intervention)
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)
Time frame: Change from baseline to 8 weeks (post-intervention)
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)
Time frame: Change from 8 weeks to 6 months (post-intervention)
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)
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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)
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)
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
Time frame: Change from 8 weeks to 6 months (post-intervention)
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
Time frame: Change from baseline to 8 weeks (post-intervention)