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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00629330
Recruitment Status : Terminated (Principal Investigator left the institution.)
First Posted : March 6, 2008
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Academic Detailing Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Dissemination of Prostate Cancer Screening to Primary Care Physicians in African American Communities
Study Start Date : January 2004
Primary Completion Date : March 2008
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Multi-component Academic Detailing
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.
Behavioral: Academic Detailing
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
Other Name: Multi-component Academic Detailing


Outcome Measures

Primary Outcome Measures :
  1. PSA and DRE [ Time Frame: 12-month followup ]

Secondary Outcome Measures :
  1. Counseling on PSA testing [ Time Frame: 12-month followup ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629330


Sponsors and Collaborators
Columbia University
United States Department of Defense
Investigators
Principal Investigator: Sherri Sheinfeld Gorin, PhD Columbia University
More Information

Responsible Party: Theresa J. Miller, Ph.D., Grants Manager, United States Army Medical Research and Materiel Command (USAMRMC)
ClinicalTrials.gov Identifier: NCT00629330     History of Changes
Other Study ID Numbers: AAAA6313
PC020492 ( Other Identifier: Department of Defense )
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: February 2011

Keywords provided by Columbia University:
prostate cancer
prostate cancer screening
prostate specific antigen
African American males

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases