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Recruiting NCT06064149

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CARE-PC Web-Based Application.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • CARE-PC Web-Based Application Completion Rate [Time frame: 18 months]
Secondary outcome measures (6)
  • Patient acceptance and perception of the web-based application [Time frame: 18 months]
  • Percent accuracy of patient-derived CV- and prostate cancer-related data elements [Time frame: 18 months]
  • Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation [Time frame: 18 months]
  • Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation [Time frame: 18 months]
  • Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation [Time frame: 18 months]
  • Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation. [Time frame: 18 months]

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: n/a

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Abramson Cancer Center of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06064149 · UPCC 07823 · 853844

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗