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

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CARE-PC Web-Based Application
Sponsored by
Vivek Narayan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Men With Prostate Cancer Planned for Receiving ADT

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    CARE-PC Web-Based Application Completion Rate
    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

    Patient acceptance and perception of the web-based application
    Acceptance/perception measured by brief embedded survey following participation in the web-based application
    Percent accuracy of patient-derived CV- and prostate cancer-related data elements
    Accuracy 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 participation
    Prevalence assessed through parallel medical chart review by cardiology and oncology clinicians
    Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation
    Patient reported cardiologist involvement via CARE-PC application at time of application survey completion
    Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation
    CV 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.
    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

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Vivek Narayan
    Collaborators
    National Comprehensive Cancer Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06064149
    Brief Title
    The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC) Pilot Feasibility Study
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 23, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Vivek Narayan
    Collaborators
    National Comprehensive Cancer Network

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Men With Prostate Cancer Planned for Receiving ADT
    Arm Type
    Other
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    CARE-PC Web-Based Application
    Intervention Description
    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 Measure Information:
    Title
    CARE-PC Web-Based Application Completion Rate
    Description
    Completion rate measured as the proportion of participants successfully completing the web-based application out of the total number of subjects approached.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Patient acceptance and perception of the web-based application
    Description
    Acceptance/perception measured by brief embedded survey following participation in the web-based application
    Time Frame
    18 months
    Title
    Percent accuracy of patient-derived CV- and prostate cancer-related data elements
    Description
    Accuracy assessed through parallel medical chart review by cardiology and oncology clinicians
    Time Frame
    18 months
    Title
    Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation
    Description
    Prevalence assessed through parallel medical chart review by cardiology and oncology clinicians
    Time Frame
    18 months
    Title
    Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation
    Description
    Patient reported cardiologist involvement via CARE-PC application at time of application survey completion
    Time Frame
    18 months
    Title
    Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation
    Description
    CV care engagement assessed through medical chart review by investigators within 6 months post-application survey completion
    Time Frame
    18 months
    Title
    Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.
    Description
    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
    Time Frame
    18 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthew Doyle
    Phone
    610-357-6354
    Email
    matthew.doyle@pennmedicine.upenn.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vivek Narayan, MD
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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