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Clinical Trials/NCT06064149
NCT06064149
Recruiting
Not Applicable

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

Vivek Narayan1 site in 1 country100 target enrollmentNovember 14, 2023
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Vivek Narayan
Enrollment
100
Locations
1
Primary Endpoint
CARE-PC Web-Based Application Completion Rate
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2023
End Date
August 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Vivek Narayan
Responsible Party
Sponsor Investigator
Principal Investigator

Vivek Narayan

Principal Investigator

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

CARE-PC Web-Based Application Completion Rate

Time Frame: 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 Outcomes

  • Percent accuracy of patient-derived CV- and prostate cancer-related data elements(18 months)
  • Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.(18 months)
  • Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation(18 months)
  • Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation(18 months)
  • Patient acceptance and perception of the web-based application(18 months)
  • Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation(18 months)

Study Sites (1)

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