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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: CARE-PC Web-Based Application

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Doyle; Phone Number: 610-357-6354; Email: matthew.doyle@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center of the University of Pennsylvania
      • Contact: Vivek Narayan, MD; Phone Number: 215-360-0737; Email: PennCancerTrials@emergingmed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Men With Prostate Cancer Planned for Receiving ADT; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vivek Narayan
• Collaborators: National Comprehensive Cancer Network
• Investigators: Principal Investigator: Vivek Narayan, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UPCC 07823; 853844 (Other Identifier: University of Pennsylvania IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No