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
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
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
NCT ID
NCT00629330
First Posted
February 26, 2008
Last Updated
October 12, 2015
Sponsor
Columbia University
Collaborators
United States Department of Defense
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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