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

This study has been terminated.
(Principal Investigator left the institution.)
Sponsor:
Collaborator:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00629330
First received: February 26, 2008
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Prostate Cancer
Behavioral: Academic Detailing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Dissemination of Prostate Cancer Screening to Primary Care Physicians in African American Communities

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • PSA and DRE [ Time Frame: 12-month followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Counseling on PSA testing [ Time Frame: 12-month followup ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: January 2004
Study Completion Date: November 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629330

Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Sherri Sheinfeld Gorin, PhD Columbia University
  More Information

No publications provided

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
Study First Received: February 26, 2008
Last Updated: February 28, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 29, 2014