Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
March 11, 2025 updated by: Wake Forest University Health Sciences
A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Investigators are conducting this study to find out more about what heart health means to participants and how healthcare providers can best help to manage heart health.
Participants will be asked to view an electronic tool designed to promote heart health awareness and help to manage heart health outside of the clinic.
This study will provide important information to help investigators develop future programs that improve cancer patient's heart health after they complete their treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Secondary Objectives:
- To assess patient satisfaction with the tool.
- To identify the proportion of patients with non-ideal cardiovascular health scores who report initiating discussions regarding cardiovascular health during their routine oncology appointment.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Scheduled for a routine surveillance visit for pathologically confirmed stages I-IV endometrial cancer
- Greater than or equal to 3 months post-potentially curative cancer treatment
- Patients must be at least 18 years of age
- Have a working email address
- Comfortable reading medical information in English, as per self-report
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PREVENT - Cardiovascular Health Assessment Tool
An adapted version of the PREVENT tool for endometrial cancer survivors will be used collect data during routine follow-up care for endometrial cancer that will yield a cardiovascular health score based on the Simple 7 risk factors (current smoking habits, body mass index, physical activity, diet, cholesterol, blood pressure and fasting plasma glucose).
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Participants will access a heart health information visualization tool online using a personal device or a study tablet computer using their e-mail address to log-in.
Investigators will review participant lab results specifically related to their cardiovascular health (e.g.
blood pressure, cholesterol) in order to personalize the heart health tool for participants.
A brief survey before and after use of the tool will also be completed by participants.
A brief survey before and after use of the tool will also be completed by participants.
Participants will be asked questions related to their heart health.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants to Complete Intervention - Feasibility
Time Frame: 6 months
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Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Time Frame: 6 months
|
Patient satisfaction will be 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.
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 and heart disease before and after using the cardiovascular risk visualization tool.
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6 months
|
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Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Time Frame: 6 months
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The initiation of discussions with participants' health care providers will largely be descriptive (using means as a measurement) to analyze this measure. Participants responded yes/no to the following discussions: 1) Losing weight and maintaining a healthy body weight? 2) Quitting smoking, or staying smoke-free? 3) Controlling your blood pressure? 4) Controlling your cholesterol? 5) Controlling your glucose or hemoglobin A1c? 6) Any discussion regarding health with health care providers |
6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kathryn E Weaver, PhD, MPH, Wake Forest Baptist Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2023
Primary Completion (Actual)
June 7, 2024
Study Completion (Actual)
June 7, 2024
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 11, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00095005
- P30CA012197 (U.S. NIH Grant/Contract)
- WFBCCC 99123 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.