A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Phase: NA
Conditions: Endometrial Cancer, Survivorship
Sponsor: Wake Forest University Health Sciences

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive 
 Center (WFBCCC) 
WFBCCC 99123 
Principal Investigator: 
Name and Title 
Kathryn E. Weaver, PhD, MPH 
Department / Section Name 
Department of Social Sciences 
and Health Policy 
Email Address 
Phone Number 
Biostatistician: 
Name and Title 
Emily Dressler, PhD 
Department / Section Name 
Department of Biostatistics and 
Data Science 
Email Address 
Phone Number 
Study Coordinator: 
Name and Title 
Megan N. Jenkins, MS 
Email Address 
Phone Number 
Regulatory Contact: 
Name and Title 
Cindy Miller 
Email Address 
Phone Number 
Participating Institution(s): Wake Forest Baptist Comprehensive Cancer Center 
Original Version Date:  03.10.23 
Amended: 
05.11.23 
Confidential
ClinicalTrials.gov:  NCT05796518

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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Table of Contents 
SCHEMA ...................................................................................................................................... 3 
1.0 
Introduction and Background ............................................................................................ 4 
2.0 
Objectives ......................................................................................................................... 5 
2.1 
Primary Objective .......................................................................................................... 5 
2.2 
Secondary Objectives ................................................................................................... 5 
3.0 
Study Population ............................................................................................................... 5 
3.1 
Inclusion Criteria............................................................................................................ 5 
3.2 
Exclusion Criteria .......................................................................................................... 6 
3.3 
Inclusion of Women and minorities ............................................................................... 6 
4.0 
Methods ............................................................................................................................ 6 
4.1 
Registration Procedures ................................................................................................ 6 
4.2 
Experimental or Data Collection Methods ..................................................................... 7 
4.3 
Study-Related Activities ................................................................................................ 8 
5.0 
Outcome Measures ......................................................................................................... 10 
5.1 
Primary Outcome ........................................................................................................ 10 
5.2 
Secondary Outcomes .................................................................................................. 10 
6.0 
Analytic Plan ................................................................................................................... 10 
6.1 
Sample Size and Power .............................................................................................. 10 
6.2 
Analysis of Primary Outcome ...................................................................................... 10 
6.3 
Analysis of Secondary Outcomes ............................................................................... 10 
6.4 
Accrual Rate ................................................................................................................ 11 
6.5 
Length of Study ........................................................................................................... 11 
7.0 
Data Management ........................................................................................................... 12 
8.0 
Confidentiality and Privacy .............................................................................................. 12 
9.0 
Data Safety and Monitoring ............................................................................................. 13 
10.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations ............................ 13 
References .................................................................................................................................. 14 
Appendix A – Subject Eligibility Checklist ............................................................................. 17 
Appendix B – Protocol Registration Form ............................................................................. 19 
Appendix C - Race & Ethnicity Verification Form .................................................................. 20 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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SCHEMA 
 
 
Study Population:  Endometrial cancer survivors presenting to WFBCCC for post-treatment 
surveillance visit. 
 
 
Intervention:  
Implementation of the PREVENT cardiovascular health (CVH) assessment 
tool and provider education sessions  
 
 
 
Data Collection from Survivors: Pre-visit, post-visit and 1 months - demographics, referrals to 
health services (including primary care and cardiology), CVH discussions, cardiovascular risk 
factor data 
 
 
 
Primary Endpoint:  Proportion of patients who consent to the study and complete the web-based 
heart health assessment. 
 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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1.0 
Introduction and Background 
 
Endometrial cancer is the most common gynecologic malignancy, and with 
approximately two-thirds of cases being diagnosed at an early stage it carries an 
excellent 5-year overall survival of approximately 95%.1 Survivors of endometrial cancer 
are more likely to die of their comorbidities than their cancer, and cardiovascular 
disease (CVD) is not only the leading cause of death in the United States but has also 
been found to be the leading cause of death among endometrial cancer patients.2-4 This 
is likely due to the multiple overlapping risk factors for endometrial cancer and CVD 
including obesity and metabolic syndrome, elevating the importance of addressing 
cardiovascular (CV) health in routine survivorship care.5,6 Treatment of endometrial 
cancer adds to this risk, with a decrease in physical activity and subsequent weight gain 
during the post-operative period and concurrently undergoing adjuvant treatment with 
chemotherapy or radiation. 
The National Comprehensive Cancer Network (NCCN) recommends assessment 
of CVD  risk in their endometrial cancer survivorship guidelines.9 This is reinforced in 
the primary gynecologic oncology literature, with CVD risk assessment in patients with 
endometrial cancer suggested to be implemented as early in survivorship care as 
possible.2 However, implementing this guideline in routine oncology practice may be 
challenging. Using survey data of over 1500 patients with breast, prostate, colorectal 
and gynecologic cancers, Weaver at al. found that one in three survivors with at least 
one CV risk factor reported no discussion of health promotion with their oncologic 
provider.10 Similarly, in a survey of 700 patients with a cancer diagnosis, Nicolaije et al. 
found that 35% of patient responded that they were minimally informed on how to 
improve their health, with 42% responding that they were completely uninformed on 
how to improve their health.11 Ninety percent of oncologists in an electronic health 
record (EHR) tool pilot study (18 of 20) reported CV health discussions to be 
“somewhat” or “very” important; however, 58% “rarely” or “sometimes” discuss CV 
health with their patients.12 As a result, oncologists make few referrals for CV care to 
primary care and cardiology for guideline-driven follow-up care.10,13-15  
Primary care is a key partner for managing CV health among cancer survivors. 
We are not aware of any studies specifically looking at primary care practitioner (PCP) 
utilization by endometrial cancer survivors, however, studies have shown that up to 20% 
of patients with a history of breast or colon cancer did not see a PCP within the first year 
of survivorship.7,8 Unsurprisingly, these patients were less likely to get preventative care 
and have chronic and general health issues managed than those who saw a PCP in 
addition to an oncology provider. Data from the original Automated Heart Health 
Assessment (AH-HA) team and others show that survivors want to have preventative 
discussions with their oncologists.16 Although some oncology providers are hesitant to 
address obesity and exercise in cancer survivors, exercise recommendations by 
providers increase cancer survivors’ physical activity by up to 30 minutes per week.17-19 
Behavioral interventions for weight loss, exercise, diet, and smoking cessation, even if 
brief, can be successful in improving CV health among cancer survivors.20-25 For 
example, the odds of abstinence from smoking at 6 months increased 66% with 
provider lifestyle advice.25 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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Web-based cardiovascular health assessment tools may play an important role in 
successful guideline implementation. The AH-HA tool, currently being tested in a large 
multi-site trial, is a provider facing EHR-embedded CV health assessment tool that 
renders a visual, interactive display of CVH risk factors, automatically populated from 
the EHR.26 However, EHR integrated tools may require substantial time and cost for 
successful integration. A similar tool, named PREVENT, was developed by co-
investigators on the proposed study using the American Heart Association (AHA) 
Simple 7 criteria for adolescent and young adult cancer patients, but is a web based, 
patient facing tool. This tool provides a graphic representation of the validated overall 
CV health score based on the Simple 7 risk factors27, and provides behavior change 
recommendations to improve CV health. Provider and patient facing tools may offer 
implementation options to oncology clinics or be used as complementary strategies. 
In this study, we will pilot an adapted version of the PREVENT tool for 
endometrial cancer survivors. This study will focus on the feasibility of using the 
PREVENT tool within routine follow-up care for endometrial cancer. 
2.0 
Objectives 
2.1 
Primary Objective 
The primary objective of this pilot study is to assess the feasibility of 
enrolling and completing the heart health assessment among endometrial 
cancer patients scheduled for routine follow-up care. 
2.2 
Secondary Objectives 
2.2.1 To assess patient satisfaction with the tool. 
2.2.2 To identify the proportion of patients with non-ideal cardiovascular 
health scores who report initiating discussions regarding 
cardiovascular health during their routine oncology appointment. 
3.0 
Study Population 
 
Endometrial cancer survivors presenting to WFBCCC for post-treatment 
surveillance visit.  
3.1 
Inclusion Criteria 
3.1.1 Scheduled for a routine surveillance visit for pathologically 
confirmed stages I-IV endometrial cancer  
3.1.2 ≥ 3 months post-potentially curative cancer treatment  
3.1.3 Patients must be at least 18 years of age 
3.1.4 Have a working email address  
3.1.5 Comfortable reading medical information in English, as per self-
report 
 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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3.2 
Exclusion Criteria   
3.2.1 Currently receiving treatment (e.g. radiation, chemotherapy, 
immunological treatments for endometrial cancer) 
3.2.2 Have a history of endometrial cancer recurrence  
3.2.3 Enrolled in hospice care or documentation of life expectancy < 6 
months 
3.3 Inclusion of Women and minorities 
3.3.1 Women of all races and ethnicity who meet the above-described 
eligibility criteria are eligible for this trial. All of the participants will 
be women. 
 
Minority Estimates: Similar to the national population data for 
cancer survivors and the demographics of the cancer patient 
population at the CCCWFU, non-Hispanic whites are expected to 
comprise the majority of our sample.  Based on our cancer center 
data, we expect approximately 2% of included participants to be 
Hispanic/Latino (N=1). The breakdown of racial categories is 
expected to be as follows:  14% Black or African American (N=5), 
and 84% White (N=35), and 2% more than one race (N=1). 
 
Should we not meet or exceed these estimates, the PI will engage 
the Office of Cancer Health Equity to discuss strategies to enhance 
recruitment in these target populations. 
 
4.0 
Methods 
4.1 
Registration Procedures 
 
All patients entered on any WFBCCC trial, whether treatment, companion, 
or cancer control trial, must be linked with a study protocol in EPIC within 
24 hours of Informed Consent. Patients must be registered prior to the 
initiation of the study.   
 
You must perform the following steps in order to ensure prompt 
registration of your patient: 
 
1.0 
Complete the Eligibility Checklist (Appendix A) 
2.0 
Complete the Protocol Registration Form (Appendix B) 
3.0 
Alert the Cancer Center registrar by phone, and then send the 
Informed Consent Form, Eligibility Checklist and Protocol 
Registration Form to the registrar, either by fax or e-mail. 
 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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Contact Information: 
Protocol Registrar PHONE 
 
Protocol Registrar FAX 
 
Protocol Registrar E-MAIL 
 
            
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-
Friday. 
 
4.0 
Fax/e-mail ALL eligibility source documents with registration. 
Patients will not be registered without all required supporting 
documents. 
Note: If labs were performed at an outside institution, provide a printout of 
the results. Ensure that the most recent lab values are sent. 
 
To complete the registration process, the Registrar will:   
 
• assign a patient study number 
• register the patient on the study 
 
 
4.2 
Experimental or Data Collection Methods 
 
Data will be collected through patient surveys via REDCap, and the 
PREVENT tool, as well as via medical chart abstraction for lab values and 
vital signs. 
 
4.2.1 EHR data extraction 
Patient demographics (e.g., sex, date of birth, race/ethnicity) and 
the most recent risk factors for CVH (height, weight, fasting blood 
glucose, total cholesterol, blood pressure, smoking status) will be 
extracted at baseline (prior to clinic visit). Available EHR data will 
be uploaded into PREVENT prior to the clinic visit but may be 
updated within the PREVENT tool at the time of the clinic visit if 
updated values are attained. We acknowledge that not all patients 
will have updated information for CVH risk factors (fasting blood 
glucose, Hemoglobin A1c and total cholesterol). This pilot study is 
intended to determine what data are commonly available for a 
future study. We expect that height and weight will be the most 
commonly available data point. 
 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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4.2.2 Survey data 
The pre-assessment survey will be sent electronically using 
REDCap to give the patient the option of completing the survey 
prior to the clinic visit. Alternatively, the patient may complete the 
questionnaire while in the waiting room at the clinic. The post-
assessment survey will also be sent electronically using REDCap. 
 
4.3 
Study-Related Activities  
 
 
 
 
Screeninga 
Pre-Visit 
Assessmenta,b 
During 
Visit 
Post-Visit 
Assessmentc 
(+ 14 Days) 
1 Month 
Post-Visitf 
(+/- 15 Days) 
Eligibility 
X 
 
 
 
 
Screen Failure Form  
X 
 
 
 
 
Informed Consent 
 
 
X 
 
 
 
Health Assessment 
 
 
X 
 
X 
 
Health Visit 
Information 
 
 
X 
 
 
 
Health Knowledge 
Assessment 
 
 
X 
 
X 
 
Demographic & Health 
Behaviors 
 
 
X 
 
 
 
Referral Assessment 
 
 
 
 
X 
 
Tool Use 
 
 
Xe 
 
 
Tool Assessment 
 
 
 
 
X 
 
Medical Record Data 
 
 
Xd 
 
 
X 
a) Occurs pre-registration. 
b) Pre-visit assessment may be completed online via REDCap or on the day of study visit. 
c) Post-visit assessment should be completed at the end of study visit. If post-visit assessment 
cannot be completed at the end of the study visit, the assessment may be completed online 
by the patient via REDCap, ideally within 48 hours of study visit.  
d) Most recent patient vitals as well as fasting blood glucose, Hemoglobin A1c and total 
cholesterol will be extracted provided test results are within five years. Data extraction may 
be completed prior to visit or on day of study visit.  
e) This data will be collected directly in the tool and will not need to be entered in REDCap by 
staff. 
f) 
This is chart abstraction by staff, using the HER and data extraction form. There is no 
additional patient visit associated with this activity. 
 
Basic Study Overview 
This will be a single arm pilot study conducted at a single academic 
medical center (WFBCCC). We will identify, recruit, and consent endometrial 
cancer patients scheduled for a routine surveillance visit with a gynecologic 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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oncology provider. Patients will consent to the study and complete a brief 
questionnaire electronically prior to presenting for their office visit. Once they 
have been roomed in the office, a research team member will assist them in the 
use of the PREVENT tool, yielding a cardiovascular health score. Questions 
regarding the score will be directed towards their oncologic provider. They will 
then complete a brief questionnaire immediately after the visit. Chart review will 
be conducted 3 months after the visit.  
 
Consent and Survey Administration: We will request a waiver of signed 
informed consent for the study (see Protection of Human Subjects). Potential 
participants identified from cancer center appointment schedules or referred by 
clinicians and navigators will be recruited by patient portal, phone, or in-person to 
complete brief web-based surveys before and after their regularly scheduled 
medical appointment. A record of screening failures will be captured Survey 
participants will receive a $10 gift card.  
 
Pre-Assessment Questionnaire: Prior to exposure to the PREVENT tool, we 
will ask 8 questions about CVH knowledge and perceived importance and 
appropriateness of heart health discussions during oncology care.  
 
PREVENT Tool Interaction: While the patient is having their regularly scheduled 
medical appointment, the study coordinator will review their medical chart for 
cardiovascular risk information (weight, height, smoking status, blood pressure, 
total cholesterol, and hemoglobin A1c or fasting glucose). The most recent data 
will be entered in the PREVENT tool for the patient. We will help survivors 
access a patient-facing version of the PREVENT tool using a personal device or 
a study tablet computer. Survivors will use a personal email address to log-in to 
the patient-facing web application and will receive a welcome email after 
configuring their PREVENT profile.  Patients will have the opportunity to review 
and update any of their cardiovascular risk information, as well as read 
information about cardiovascular health. The research coordinator will assist 
survivors in using the tool if requested.   
 
Post-Assessment Questionnaires: Following survivor interaction with the 
PREVENT tool, survivors will complete: 
 
• The same eight pre-assessment questionnaire along with three additional 
questions.  
 
• We will additionally ask 5 questions regarding use of the PREVENT tool.  
 
Collection of Post-Intervention Clinical Follow Up:  Data will be collected 
about referrals, labs and new medications that occur during the 3-month period 
after their use of the study tool. 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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5.0 
Outcome Measures 
5.1 
Primary Outcome 
Proportion of patients who consent to the study and complete the web-
based heart health assessment. 
5.2 
Secondary Outcomes 
5.2.1 Secondary objective 2.2.1, patient satisfaction identified through 
post-visit survey with a 5-point Likert scale (strongly agree to 
strongly disagree) regarding liking the tool, helpfulness, ease of 
understanding and desire to use this tool with their oncologist. 
 
5.2.2 Secondary objective 2.2.2, proportion of patients who report 
initiating discussions regarding cardiovascular health, identified 
through post-visit survey.  
6.0 
Analytic Plan 
6.1 
Sample Size and Power 
 This pilot study has an accrual goal of 42 endometrial cancer survivors. 
This study focuses on the feasibility of implementing the PREVENT tool to 
promote discussion of cardiovascular health risks between providers and 
cancer survivors. Feasibility will be defined from the proportion of patients 
who complete the web-based assessment. A sample size of 42 total 
participants will have 83% power to detect a hypothesized participation 
rate of 80% or more with an unacceptable participation rate considered 
60% or less. This assumes a conservative 10% dropout of participants 
prior to the time of visit, with a one-sided alpha=0.05, and one-sample 
exact binomial test. Assuming 37 survivors complete the assessment, we 
will be able to estimate participation within +/- 17% using exact 95% 
binomial confidence intervals. A sample size of 37 survivors would allow 
for reasonable estimates of SDs that could be used for future studies. 
6.2 
Analysis of Primary Outcome 
For our primary objective, analyses will be largely descriptive (using 
means, medians, frequencies etc.).  
6.3 
Analysis of Secondary Outcomes 
For secondary objective 2.2.1, patient satisfaction with the tool, one-sample 
t-tests will be used to test whether the average response to each question is 
greater than 3.5 (with three denoting a neutral response). Wilcoxon signed 
rank tests will be used to compare cancer survivors’ knowledge regarding 
their cardiovascular health risk factors and perceived importance of cancer 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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and heart disease before and after using the CV risk visualization tool. 
Categorical comparisons will be evaluated with Fisher’s Exact test. 
 
For secondary objective 2.2.2, analyses will be largely descriptive (using 
means, medians, frequencies etc.). 
6.4 
Accrual Rate 
Accrual is expected to be 10 patients per month, based on an estimated 
20 endometrial cancer survivors seen by the gynecologic oncology 
department for surveillance in the average month.  
6.5 
Length of Study 
Targeted accrual should be met in approximately 6 months. A maximum of 
42 patients will be enrolled on this trial. 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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7.0 
Data Management 
 
Data Collection Form 
Data Storage Location 
Informed Consent Document 
EPIC 
Subject Eligibility Checklist 
WISER/OnCore 
Protocol Registration Form 
WISER/OnCore 
Race & Ethnicity Form 
WISER/OnCore 
Screen Failure Form 
REDCap 
Pre-visit Baseline Survivor Survey 
REDCap 
Data entered into PREVENT 
Google Firebase 
Post-Baseline Survivor Survey 
REDCap 
Tool Assessment (v1.0) 
REDCap 
Gift Card Tracking Form 
REDCap 
Medical Record Extraction 
REDCap 
Off Treatment Form 
WISER/OnCore 
Off Study Form 
WISER/OnCore 
Withdrawal of Consent 
WISER/OnCore 
Survival Form 
WISER/OnCore 
 
This project will utilize REDCap Clinical Data Interoperability Services. This is a special 
feature for importing data into REDCap from WakeOne. It provides an adjudication 
process whereby REDCap users can approve all incoming data from WakeOne before it 
is officially saved in their REDCap project. REDCap Clinical Data Interoperability 
Services can only be enabled by a REDCap administrator who serves as an honest 
broker to PHI. REDCap’s Clinical Data Interoperability Services can only be accessed by 
users with valid WakeOne credentials. Using the Clinical Data Interoperability Service 
requires using the Medical Record Number (MRN) as a key to automatically gather 
demographics and laboratory data and reduces data entry errors. 
8.0 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess 
study outcomes, minimizing to the fullest extent possible the collection of any 
information that could directly identify subjects, and maintaining all study 
information in a secure manner. To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection 
form. Any collected patient identifying information corresponding to the unique 
study identifier will be maintained on a linkage file, store separately from the 
data. The linkage file will be kept secure, with access limited to designated study 
personnel. Following data collection, subject identifying information will be 
destroyed two years after closure of the study, consistent with data validation and 
study design, producing an anonymous analytical data set. Data access will be 
limited to study staff. Data and records will be kept locked and secured, with any 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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computer data password protected. No reference to any individual participant will 
appear in reports, presentations, or publications that may arise from the study. 
9.0 
Data Safety and Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data 
and safety of study participants. The principal investigator will be assisted by 
other members of the study staff. 
 
Data will be stored on a secure information technology-maintained computing 
infrastructure behind the WFBH firewall, which has been certified to store 
protected health information. Data from the PREVENT tool will also be stored on 
a secure information technology-maintained platform (Google Firebase) that 
complies with HIPPA standards. We will take consistent measures to protect the 
confidentiality of these data. When the data are collected and ready for analysis, 
the dataset will be downloaded by Dr. DeMari and used only for the purposes 
identified in these analyses. Only approved members of the research team will 
have access to these data. 
10.0 Reporting of Unanticipated Problems, Adverse Events or 
Deviations 
 
Any unanticipated problems, deviations or protocol changes will be promptly 
reported by the principal investigator or designated member of the research team 
to the IRB and sponsor or appropriate government agency if appropriate. 
 
 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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As Standard of Care. Journal of Clinical Oncology. 2014;32:2518- 2519.  
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Aitken JF, Meng X and Courneya KS. Effects of a Telephone-Delivered Multiple 
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Outcomes in Survivors of Colorectal Cancer: A Randomized Controlled Trial. 
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smoking cessation interventions for smokers aged 50 and older. Maturitas. 
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(review). The Cochrane Library. 2008. 
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cardiovascular health using the automated heart health assessment (AH-HA) 
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Contemp Clin Trials Commun. Jun 2021;22:100808. 
doi:10.1016/j.conctc.2021.100808 

A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
05.11.23                                                  Page 16 of 20 
 
27. 
Lloyd-Jones DM, Hong Y, Labarthe D, et al. Defining and setting national goals 
for cardiovascular health promotion and disease reduction: the American Heart 
Association's strategic Impact Goal through 2020 and beyond. Circulation. Feb 2 
2010;121(4):586-613. doi:10.1161/CIRCULATIONAHA.109.192703 
 
 

 
A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
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Appendix A – Subject Eligibility Checklist 
 
 
IRB Protocol No. 
 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 
WFBCCC Protocol No 
___ ___ ___ ___ ___ 
Study Title: A pilot study to examine feasibility of a patient directed tool to assess heart 
health among endometrial cancer survivors  
Principal Investigator:  Kathryn E. Weaver, PhD, MPH 
 
Inclusion Criteria 
(as outlined in study protocol) 
Criteria 
is met 
Criteria 
is NOT 
met 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Scheduled for a routine surveillance 
visit for endometrial cancer  
 
□ 
□ 
 
≥ 3 months post-potentially curative 
cancer treatment  
 
□ 
□ 
 
Age >/= 18 years 
□ 
□ 
 
Have a working email address 
□ 
□ 
 
Comfortable reading medical 
information in English, as per self 
report 
□ 
□ 
 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria 
is 
present 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Currently receiving treatment (e.g. 
radiation, chemotherapy, 
immunological treatments for 
endometrial cancer) 
□ 
□ 
 
Have a history of endometrial cancer 
recurrence  
 
□ 
□ 
 
Enrolled in hospice care or 
documentation of life expectancy < 6 
months 
 
□ 
□ 
 
 
This subject is      
 eligible /  ineligible     for participation in this study. 
 
OnCore Assigned PID: ___ ___ ___ ___ ___ ___ ___ ___  
 
 
 
 
Signature of research professional confirming eligibility:_______________________  
 

 
A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
Version Date 03.10.23                                                  Page 18 of 20 
  
Date: ___ ___/___ ___/___ ___ 
 
Signature of Treating Physician**:  _____________________________________  
 
Date: ___ ___/___ ___/___ ___ 
 
 
* Examples of source documents include clinic note, pathology report, laboratory results, etc. When listing 
the source, specifically state which document in the medical record was used to assess eligibility. Also 
include the date on the document. Example: “Pathology report, 01/01/14” or “Clinic note, 01/01/14” 
 
**Principal Investigator signature can be obtained following registration if needed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
Version Date 03.10.23                                                  Page 19 of 20 
  
Appendix B – Protocol Registration Form 
 
DEMOGRAPHICS 
Patient: Last Name: _____________________ First Name: ___________________________ 
MRN:          ___ ___ ___ ___ ___ ___ ___ ___ DOB (mm/dd/yy): ___ ___ / ___ ___ / ___ ___ 
ZIPCODE:  ___ ___ ___ ___ ___ 
 
 
SEX:   
  Male      Female 
 
 
 
 
Height:   ___ ___.___ inches 
Weight: ___ ___ ___.___lbs.(actual) 
Surface Area: ___ ___.___m2   
 
Primary Diagnosis: ____________________________________________________________ 
Date of Diagnosis: ___ ___ /___ ___/___ ___ 
 
Performance Status: ___    ECOG   
 
Protocol Registrar can be contact by calling 
 between 8:30 AM and 4:00 PM, Monday – Friday. 
 
Completed Eligibility Checklist and Protocol Registration Form must be hand delivered, faxed or e-mailed to 
the registrar at 
. 
 
PROTOCOL INFORMATION 
Date of Registration: 
___ ___ / ___ ___ / ___ ___ 
MD Name (last) : 
______________________       
 
 
 
 
PID # (to be assigned by OnCore): 
___ ___ ___ ___ ___ ___ ___ ___ 
 

 
A pilot study to examine feasibility of a patient directed tool to assess heart health among endometrial 
cancer survivors  
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99123 
 
Version Date 03.10.23                                                  Page 20 of 20 
  
Appendix C - Race & Ethnicity Verification Form 
 
 
Thank you so much for helping us to verify your race and ethnicity to ensure the quality 
of our information. As a brief reminder, the information you provide today will be kept 
confidential. 
 
1. Are you: 
Hispanic or Latino/a 
Not Hispanic or Latino/a 
 
2. What is your race? One or more categories may be selected. 
White or Caucasian 
Black or African American 
American Indian or Alaskan Native 
Asian 
Native Hawaiian or Other Pacific Islander 
Other, Please Specify: ________________ 
 
 
Internal use only: 
 
 
 Name: ____________________ MRN#: ____________________  
 
Was the self-reported race and ethnicity of the participant verified at the time of 
consent? 
Yes 
 
No 
 
Was a discrepancy found?  
Yes 
 
No 
         If yes, please provide what is currently indicated in the EMR:  
 
 
Ethnicity: ____________________  
Race: ____________________ 
Additional comments: 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________