Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors

Conditions
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Endometrial Cancer, Survivorship

Intervention / Treatment
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* Other: PREVENT Cardiovascular Health Assessment Tool
* Other: Survey
* Other: Interview Regarding Heart Health


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Endometrial cancer survivors presenting for post-treatment surveillance visit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREVENT - Cardiovascular Health Assessment Tool<br>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). | Other: PREVENT Cardiovascular Health Assessment Tool<br>* 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.<br>Other: Survey<br>* A brief survey before and after use of the tool will also be completed by participants.<br>Other: Interview Regarding Heart Health<br>* Participants will be asked questions related to their heart health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants to Complete Heart Health Assessment - Feasibility | Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Stating Satisfaction with PREVENT Tool | 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. | 6 months | 
| Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health with Health Care Providers | The initiation of discussions with participants' health care providers will largely be descriptive (using means as a measurement) to analyze this measure | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart health