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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064149
• Other study ID #: UPCC 07823
• Secondary ID: 853844
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Matthew Doyle
• Phone: 610-357-6354
• Email: matthew.doyle[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• CARE-PC Web-Based Application
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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vivek Narayan	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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