The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC) Pilot Feasibility Study

Study Overview
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Brief Summary
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The overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving ADT by increasing patient awareness of individualized cardiovascular risk estimates and mitigation opportunities. Patients will be given access to a web-based quality improvement tool to educate patients of cardiovascular risks in prostate cancer and to inform them of their individualized, estimated cardiovascular risk and guideline-based risk mitigation recommendations. The study will assess the feasibility of this web-based application as a cardiovascular education tool for patients with prostate cancer. The study will also evaluate if completion of the web-based tool improves cardiovascular care access and risk mitigation for patients with prostate cancer.

Official Title
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The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC): Initial Pilot Feasibility Study to Assess Patient Awareness and Risk Mitigation

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: CARE-PC Web-Based Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with prostate cancer > 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of ADT Patients must be able to read and understand English. Exclusion Criteria: n/a

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Men With Prostate Cancer Planned for Receiving ADT<br>Men with prostate cancer > 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of systemic androgen deprivation therapy (ADT). | Behavioral: CARE-PC Web-Based Application<br>* The CARE-PC app is a pragmatic, patient-oriented, web-based application that enables the education of patients regarding cardiovascular (CV) risks and collects CV and prostate cancer-related risk variables and CV care access data from prostate cancer patients receiving ADT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CARE-PC Web-Based Application Completion Rate | Completion rate measured as the proportion of participants successfully completing the web-based application out of the total number of subjects approached. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptance and perception of the web-based application | Acceptance/perception measured by brief embedded survey following participation in the web-based application | 18 months | 
| Percent accuracy of patient-derived CV- and prostate cancer-related data elements | Accuracy assessed through parallel medical chart review by cardiology and oncology clinicians | 18 months | 
| Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation | Prevalence assessed through parallel medical chart review by cardiology and oncology clinicians | 18 months | 
| Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation | Patient reported cardiologist involvement via CARE-PC application at time of application survey completion | 18 months | 
| Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation | CV care engagement assessed through medical chart review by investigators within 6 months post-application survey completion | 18 months | 
| Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation. | Proportion of participants having changes in CV risk-reducing medications assessed through parallel medical chart review by cardiology and oncology clinicians within 6 months post-application survey completion | 18 months |