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

• Sponsor: Vivek Narayan (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06064149
• Collaborator: National Comprehensive Cancer Network (Other)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 32.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Behavioral: CARE-PC Web-Based Application	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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
• Anticipated Study Start Date: Oct 6, 2023
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	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.

Outcome Measures

Primary Outcome Measures

1. CARE-PC Web-Based Application Completion Rate [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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: n/a

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Vivek Narayan
• National Comprehensive Cancer Network

Investigators

• Principal Investigator: Vivek Narayan, MD, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 13, 2023

More Information

Publications

None provided.

• Responsible Party: Vivek Narayan, Principal Investigator, Abramson Cancer Center at Penn Medicine
• ClinicalTrials.gov Identifier: NCT06064149
• Other Study ID Numbers: UPCC 07823; 853844
• First Posted: Oct 3, 2023
• Last Update Posted: Oct 3, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Oct 3, 2023