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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: CARE-PC Web-Based Application

• Registration Number: NCT06064149
• Lead Sponsor: Vivek Narayan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-03
• Study Start: 2023-11-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men With Prostate Cancer Planned for Receiving ADT	CARE-PC Web-Based Application	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States