The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC): Initial Pilot Feasibility Study to Assess Patient Awareness and Risk Mitigation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- CARE-PC Web-Based Application Completion Rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
- Not provided
Arms & Interventions
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).
Intervention: CARE-PC Web-Based Application (Behavioral)
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)
- 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)
- Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.(18 months)
- Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation(18 months)
- Patient acceptance and perception of the web-based application(18 months)
Investigators
Vivek Narayan
Principal Investigator
Abramson Cancer Center at Penn Medicine