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Dissemination of Prostate Cancer Screening to PCP's in African American Communities

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Academic Detailing
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring prostate cancer, prostate cancer screening, prostate specific antigen, African American males

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Charts of male patients age 45 -75, (using the average age of death in this population) with at least one visit to the primary care provider over the last two years will be reviewed.

Exclusion Criteria:

Exclusion criteria will include:

  • Diagnosis of cancer other than non-melanotic skin cancer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Multi-component Academic Detailing

    Arm Description

    Includes an interactive, digitized CDROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients.

    Outcomes

    Primary Outcome Measures

    PSA and DRE

    Secondary Outcome Measures

    Counseling on PSA testing

    Full Information

    First Posted
    February 26, 2008
    Last Updated
    October 12, 2015
    Sponsor
    Columbia University
    Collaborators
    United States Department of Defense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00629330
    Brief Title
    Dissemination of Prostate Cancer Screening to PCP's in African American Communities
    Official Title
    Dissemination of Prostate Cancer Screening to Primary Care Physicians in African American Communities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    Principal Investigator left the institution.
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    November 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Columbia University
    Collaborators
    United States Department of Defense

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aims of this project are to adapt and extend the use of academic detailing to the dissemination of prostate cancer (CaP) screening findings to primary care physicians practicing in African American communities. The objectives of this study are: 1. To test the hypothesis that a community physician-based educational intervention (multi-component academic detailing, including an interactive, digitized, web-based program for informed decision-making about prostate cancer, and patient education materials designed for low literacy patients) will increase physician knowledge, positive attitudes/beliefs toward screening and screening options, and prostate cancer screening (using the digital rectal exam, and the serum prostate specific antigen test) at baseline, 6-, and 12-months post- randomization, compared to the rate observed in a service- as-usual control. 1A. To demonstrate the feasibility of disseminating the American Cancer Society guidelines for prostate cancer screening among primary care practitioners using multi-component academic detailing. 2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of PC screening guidelines to different physician subgroups. The long term goal of this project is to increase prostate cancer screening among African American communities, thus decreasing cancer-related morbidity and mortality.
    Detailed Description
    We will conduct a two-arm trial, recruiting, obtaining consent, then assigning 200 physicians' offices at random to one of two arms: intervention (multi-component academic detailing including an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients) or to a service-as-usual control arm. We will query 200 physicians about their PC knowledge, attitudes/beliefs toward screening and screening options, and PSA testing at baseline, 6, and 12months post-randomization, compared to the rate observed in a service-as-usual control. Physician counseling in cancer control will be verified by a chart review at baseline and at 12months post-randomization (N=750). The instruments will assess prostate cancer knowledge, attitudes and beliefs toward screening, and uptake of the PSA. The nested design uses the physician's office as the unit of randomization, and the office as the unit of analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    prostate cancer, prostate cancer screening, prostate specific antigen, African American males

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multi-component Academic Detailing
    Arm Type
    Experimental
    Arm Description
    Includes an interactive, digitized CDROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Academic Detailing
    Other Intervention Name(s)
    Multi-component Academic Detailing
    Intervention Description
    Multi-component academic detailing including an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients
    Primary Outcome Measure Information:
    Title
    PSA and DRE
    Time Frame
    12-month followup
    Secondary Outcome Measure Information:
    Title
    Counseling on PSA testing
    Time Frame
    12-month followup

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Charts of male patients age 45 -75, (using the average age of death in this population) with at least one visit to the primary care provider over the last two years will be reviewed. Exclusion Criteria: Exclusion criteria will include: Diagnosis of cancer other than non-melanotic skin cancer.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherri Sheinfeld Gorin, PhD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Dissemination of Prostate Cancer Screening to PCP's in African American Communities

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