The Initial Efficacy of FitEx for Endometrial Cancer Survivors: A Pilot Randomized Controlled Trial of a Walking Promotion Program With or Without Yoga
Phase: NA
Conditions: Endometrial Cancer, Obesity, Sedentary Behavior, Quality of Life, Survivorship
Sponsor: Carilion Clinic

Title: FitEx for Endometrial Cancer Survivors: Initial Efficacy 
NCT trial number: NCT05737745 
November 22, 2024 
Study Protocol: 
Overview:  
This study targets 30 endometrial cancer survivors (ECS) and 2-5 support team members per 
ECS enrolled in intervention groups. We will use a 3-group design [FitEx (intervention 1) versus 
FitEx+yoga (intervention 2) versus standard-of-care (control)] with 3 assessments (pre, post 
[after 8-week program], and follow-up [6-month]). All participants will be given the option to 
receive a Fitbit Charge 5TM to objectively measure moderate-vigorous physical activity. ECS 
randomized to either intervention arm will participate in the 8-week FitEx program with their 
support team members which includes goal setting, self-monitoring, and weekly 30-minute 
synchronous sessions via Zoom. ECS in the control group will receive a one-time educational 
newsletter and will not recruit support team members. This protocol will be completed twice, 
once in 2023 and once in 2024.  
OBJECTIVES: 
• 
Aim 1: Among ECS, compare changes in objective MVPA between intervention groups 
and usual care (FitEx vs. control and FitEx+yoga vs. control) at 8 weeks.  
• 
Aim 2: Among ECS, compare secondary efficacy outcomes and maintenance.  
o 
Aim 2a: Examine changes in secondary efficacy outcomes [e.g., quality of life 
(QOL), self-compassion, flourishing, self-efficacy, social support, habituation of 
exercise, and fruit/vegetable consumption] between intervention and usual care 
conditions (FitEx versus control and FitEx+yoga versus control) at 8 weeks.  
o 
Aim 2b: Explore maintenance of MPVA and secondary outcomes between 
intervention versus usual care (FitEx vs. control and FitEx+yoga vs. control) at 6 
months.  
• 
Aim 3: Among support team members, compare changes in MVPA and secondary 
outcomes (listed above) between intervention groups (FitEx vs. FitEx+yoga) at 8 weeks 
and 6 months.  
RECRUITMENT:  
Eligible ECS will be recruited via word-of-mouth, emails, phone calls, and flyers. An 
informational video on the research project will also be used for recruitment purposes (e.g., 
linked in emails). The first person to contact a potential participant will always be a Carilion 
Clinic affiliate on this research study such as Dr. Armbruster or gynecologic oncology clinicians 
and staff or a clinical research coordinator. The person contacting the participant afterward may 
be any IRB-approved research personnel on this study. Carilion Clinic affiliates may CC other 
research study personnel onto email correspondence or reference other research study 
personnel on phone calls so that other research study personnel may take over the screening or 
consenting process after the first instance of contact.  

ECS who are randomized in either of the intervention groups may recruit up to 5 friends, family 
members, loved ones, or any support system members to join them as “support team members” 
within the study. ECS in the intervention groups will identify individuals they wish to be on their 
intervention team and share relevant contact information (phone number and/or email address 
of the potential support team members). ECS will be instructed to obtain verbal confirmation of 
interest from potential support team members before sharing information with research study 
personnel (ECS confirmation of support team member verbalizing interest in being contacted 
about the study will be tracked in REDCap). Research study personnel will then contact 
potential support team members to describe that they received their contact information from 
the enrolled ECS and to discuss the study and enrollment. 
Recruitment will be limited to 3 phone calls and 2 email attempts per participant.  
 
SCREENING & CONSENT 
If an ECS is interested in participating, research study personnel will conduct a screening 
assessment and informed consent process either in-person or virtually. If conducted in-person, 
the informed consent process documents will be stored in the study coordinator’s office at 
Carilion Clinic. If conducted virtually, the informed consent process will be documented within 
REDCap. Participants may be consented on REDCap either over the phone or via 
teleconference depending on their preference. Consents conducted via teleconference will use 
secure, password protected Microsoft Teams or WebEx platforms. Zoom will not be used to 
consent participants. Support team members will undergo the same consent process as ECS 
after follow-up call and screening. All participants will be provided ample time to decide if they 
would like to join the study. There will be multiple opportunities for the participant to opt out 
before enrollment. Prior to consent, all potential participants will be sent a copy of the consent 
form for their review. A phone call or secure, web-based teleconference will be scheduled for 
interested participants to fill out the econsent via REDCap.  
RANDOMIZATION & GROUPS 
Each ECS who enrolls in the study will be randomized into one of three groups:  
1. Standard-of-care (control) 
2. FitEx intervention (FitEx-ECS) 
3. FitEx intervention with integrated yoga principles (FitEx-ECS+yoga)  
Overall, this study targets 10 ECS per group (30 total ECS) with 2-5 support team members per 
ECS in each intervention group (approximately 30 total support team members in each 
intervention group) yearly, for 2 years (90 participants per year, 180 participants total). All 
participants will be given the option to receive a Fitbit Charge 5TM to objectively measure 
moderate-vigorous physical activity.  
Control Group:  
ECS in the control group will be given the option to receive a Fitbit and will be sent a one-time 
educational newsletter about survivorship PA and nutrition recommendations. Control group 
participants will fill out all questionnaires at baseline, post, and 6-months follow up. Control 

group participants will not recruit support team members, fill out FitEx-specific forms, nor 
participate in weekly Zoom sessions. 
Intervention Groups:  
ECS randomized to either intervention arm will participate in the 8-week FitEx program adapted 
for ECS with their support team members. The FitEx-ECS intervention will entail group 
dynamics, goal setting, self-monitoring (tracking physical activity and fruit and vegetables intake 
via the FitEx-ECS portal within Fitabase or the FitEx Individual Log form), and feedback on goal 
attainment. The FitEx-ECS+yoga intervention will entail postures, breathwork, and mindfulness 
in addition to group dynamics, goal setting, self-monitoring (tracking physical activity and fruits 
and vegetables intake via the FitEx-ECS portal within Fitabase), and feedback on goal 
attainment. Each participant of either intervention group will have the option to receive Fitbit 
Charge 5TMs, fill out repeated program forms and questionnaires, and read weekly group-
specific newsletters. Participants in either intervention will not have to pay any intervention 
program-related fees. 
Additionally, all participants will be asked to report their weight during the baseline, post-
program, and 6-month follow up questionnaires packet (see updated questionnaires document). 
Participants may also choose to report their weight using the FitEx-ECS portal within Fitabase.  
Participants from both intervention groups will also be strongly encouraged to attend weekly 
group-specific 30-minute synchronous Zoom sessions consisting of virtual physical activity and 
social support with other teams. Topics for both intervention groups are similar, however the 
FitEx-ECS+yoga group’s newsletter and virtual sessions are guided by yoga principles and 
mindfulness. Participants in the Zoom sessions will be verbally reminded of the audio recording 
at the beginning of each session. Participants may choose to turn on or off their cameras 
according to what is most comfortable.  
SMS Reminders to Sync: 
Participants in all groups with Fitbit devices who have not synced their Fitbit devices after 6 
days will receive up to a maximum of two automated SMS-based reminders per week.  
• 
Prompt: “Please open your Fitbit app and sync this past week’s activity.”  
Automated SMS-based prompts will be set up using the FitEx-ECS portal within Fitabase. 
Fitabase uses Azure Always Encrypted to encrypt phone numbers at rest and in transit to 
protect participant personal information. 
 
COMPENSATION 
After enrollment: All participants will have the option to receive Fitbit Charge 5TMs to track their 
data over the course of the study and for them to keep after the study. If a participant already 
owns a Fitbit they wish to use, they will instead be reimbursed $99 for using their personal Fitbit 
for the study. 
Post-intervention: Upon completion of the post-program exit interviews, participants in the 
intervention groups will receive $10.  

At 6-months follow-up: Upon completion of both filling out the program survey and wearing their 
Fitbit for one week at the 6-months follow-up timepoint, all participants (from any of the three 
groups) will be compensated $20.  
 
ASSESSMENTS 
All participants will be assessed at baseline (week 1), post-program (week 9), and follow-up (6 
months).  
Pre-program: 
At baseline, participants in all three groups will have the option to record Fitbit data for 7 days. 
Participants in the intervention groups will also be asked to track self-monitored physical activity, 
track self-monitored fruit and vegetables intake, and fill out the FitEx pre-program form. All 
participants will receive questionnaires. Questionnaires will be distributed via REDCap at 
baseline, post, and follow up.  
Program: 
During the 8-week duration of intervention program, Fitbit data will be collected from all 
participants in the control, FitEx-ECS, and FitEx-ECS+yoga groups.  
In both intervention groups, self-monitored physical activity and fruit and vegetables intake will 
be tracked with the FitEx-ECS portal within Fitabase or with the FitEx Individual Log (see 
attached). Intervention group-specific weekly newsletters and Zoom sessions will occur 
throughout the duration of the 8 weeks. Intervention participants will be verbally reminded of the 
audio recording at the beginning of each Zoom session.  
Additionally, a video of each session’s synchronous movement will be recorded by the instructor 
only so that participants in either intervention group who were unable to attend can participate in 
the physical movement when their schedule allows. 
Post-program: 
After the 8-week program, participants in both intervention groups will fill out the FitEx post-
program form and participants in all groups will repeat questionnaires, all distributed via 
REDCap. For both intervention groups, 30- to 45-minute semi-structured interviews will be 
scheduled and conducted with ECS survivors and support team members (See “Follow Up 
Materials” attachment for interview guide.)  
Questionnaires & surveys: 
Questionnaires for intervention groups include: 1. The Stanford Leisure-Time Activity 
Categorical Item (L-CAT) 2. 6 items from the validated Behavioral Risk Factor Surveillance 
System survey (BRFSS F/V), 3. Flourishing Index, 4. Yoga Self-Efficacy Scale (YSES), 5. Social 
Support for Exercise Survey (SSES), 6. Self-Compassion Scale Short Form (SCS-SF), 7. Self-
Reported Behavior Automaticity Index (SRBAI), and 8. The Functional Assessment of Cancer 
Therapy - Endometrial (FACT-En). Additionally, all participants will be asked to report their 
weight within the questionnaires packet (see updated questionnaires document). All 

questionnaires will be electronically facilitated with REDCap. ECS will be sent all questionnaires 
to fill out. Support team members will be sent all questionnaires to fill out except the FACT-En.  
Electronic questionnaires will be sent in an automated email via REDCap up to two times for 
each timepoint: baseline (week 1), post-program (week 9), and follow-up (6-months) 
6-month follow-up: 
All participants will be contacted via their preferred method at follow-up (6 months) to schedule 
a 7-day long follow-up assessment. All participants will be asked to record Fitbit data for the 7-
day duration and fill out questionnaires. Participants in the intervention groups will also self-
monitor other physical activity, self-monitor fruits and vegetables intake, and the FitEx follow-up 
program form. Control group participants will be invited to future iterations of the FitEx 
interventions. 
Zoom: 
This research study is using Zoom as the virtual web conferencing platform for weekly 
meetings. The meetings conducted during this study will be recorded by the researcher using 
the audio and video recording capabilities available in the Zoom videoconferencing platform.  
STATISTICAL ASSESSMENT: 
Measures  
Due to the small sample size and exploratory nature of this pilot study, statistical analyses will 
be descriptive rather than inferential. However, we will determine if a signal exists between 
intervention and control groups regarding participants’ physical activity using MET (metabolic 
equivalents) data from Fitbits. Weekly data will be compared at week-8 (intervention conclusion) 
to baseline. Data is considered appropriate it was collected from at least 4 days per week. Data 
from missing days was input at “0”. Students T-tests were used to compare means from each 
intervention group to the control condition for the primary outcome.  
 
Attendance/Retention Measures 
Participants who enroll in the study will be asked to attend weekly meetings. The attendance at 
the meetings will be recorded to assess the percentage of participants who are interested in 
weekly meetings. The acceptability of FitEx will be assessed in part using meeting attendance. 
Attendance and retention will be used as measures of intervention acceptability. 
The number of support group members who attend each session will also be noted. The ratio of 
support group members to endometrial cancer survivor participants will also be noted. 
We will examine our attrition rate and attendance as noted above. We will also reach out to 
participants who do not complete our study to determine the reasons for their decisions. Our 
study will be feasible in its current state if our attrition rate is between 10-27%.