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

NCT ID: NCT06064149

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-14

Study Completion Date

2026-08-01

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

CARE-PC Web-Based Application

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

Vivek Narayan

OTHER

Sponsor Role lead

Responsible Party

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Vivek Narayan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vivek Narayan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew Doyle

Role: CONTACT

610-357-6354

Facility Contacts

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Vivek Narayan, MD

Role: primary

215-360-0737

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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853844

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 07823

Identifier Type: -

Identifier Source: org_study_id

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