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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06064149
Enrollment
100
Registered
2023-10-03
Start date
2023-11-14
Completion date
2026-08-01
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

BEHAVIORALCARE-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.

Sponsors

National Comprehensive Cancer Network
CollaboratorNETWORK
Vivek Narayan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CARE-PC Web-Based Application Completion Rate18 monthsCompletion rate measured as the proportion of participants successfully completing the web-based application out of the total number of subjects approached.

Secondary

MeasureTime frameDescription
Percent accuracy of patient-derived CV- and prostate cancer-related data elements18 monthsAccuracy assessed through parallel medical chart review by cardiology and oncology clinicians
Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation18 monthsPrevalence assessed through parallel medical chart review by cardiology and oncology clinicians
Patient acceptance and perception of the web-based application18 monthsAcceptance/perception measured by brief embedded survey following participation in the web-based application
Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation18 monthsCV care engagement assessed through medical chart review by investigators within 6 months post-application survey completion
Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.18 monthsProportion 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
Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation18 monthsPatient reported cardiologist involvement via CARE-PC application at time of application survey completion

Countries

United States

Contacts

Primary ContactMatthew Doyle
matthew.doyle@pennmedicine.upenn.edu610-357-6354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026