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TerminatedNCT00629330Updated Oct 14, 2015

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

A Phase 4 interventional study of Academic Detailing in Prostate Cancer, sponsored by Columbia University. Terminated. Open to male participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by Columbia University · Phase 4, Interventional, and Screening

Why this study was terminated
Principal Investigator left the institution.
Phase
Phase 4
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
Male
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Study 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.

  1. 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.

Read the 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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer
  • prostate cancer screening
  • prostate specific antigen
  • African American males
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In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 86 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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.
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Study design

Phase
Phase 4
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralAcademic 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

    Also known as: Multi-component Academic Detailing

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What researchers measure

Primary outcomes

  1. PSA and DRE

    Time frame: 12-month followup

Secondary outcomes

  1. Counseling on PSA testing

    Time frame: 12-month followup

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00629330
Lead sponsor
Columbia University
Collaborators
United States Department of Defense
First posted
Mar 6, 2008
Start date
Jan 2004
Primary completion
Mar 2008
Completion
Nov 2010
Last update
Oct 14, 2015

Study contacts

Sherri Sheinfeld Gorin, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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