NCT00629330

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for phase_4 prostate-cancer

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4 prostate-cancer

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 14, 2015

Status Verified

February 1, 2011

Enrollment Period

4.2 years

First QC Date

February 26, 2008

Last Update Submit

October 12, 2015

Conditions

Keywords

prostate cancerprostate cancer screeningprostate specific antigenAfrican American males

Outcome Measures

Primary Outcomes (1)

  • PSA and DRE

    12-month followup

Secondary Outcomes (1)

  • Counseling on PSA testing

    12-month followup

Study Arms (1)

Multi-component Academic Detailing

EXPERIMENTAL

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

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
Multi-component Academic Detailing

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Sherri Sheinfeld Gorin, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

January 1, 2004

Primary Completion

March 1, 2008

Study Completion

November 1, 2010

Last Updated

October 14, 2015

Record last verified: 2011-02