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NCT Number: NCT06064149

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Vivek Narayan, MD

CONTACT

[email protected]

215-360-0737

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARE-PC Web-Based Application

Behavioral

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.

Primary outcomes

  1. 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

  1. Patient acceptance and perception of the web-based application

    Time frame: 18 months

    Acceptance/perception measured by brief embedded survey following participation in the web-based application

  2. Percent accuracy of patient-derived CV- and prostate cancer-related data elements

    Time frame: 18 months

    Accuracy assessed through parallel medical chart review by cardiology and oncology clinicians

  3. Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation

    Time frame: 18 months

    Prevalence assessed through parallel medical chart review by cardiology and oncology clinicians

  4. Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation

    Time frame: 18 months

    Patient reported cardiologist involvement via CARE-PC application at time of application survey completion

  5. Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation

    Time frame: 18 months

    CV care engagement assessed through medical chart review by investigators within 6 months post-application survey completion

  6. Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Doyle

CONTACT

[email protected]

610-357-6354

Sponsors and collaborators

Lead sponsor

Vivek Narayan

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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