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Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Screening Active 45 to 65 Other CDC-NCCDPHP-2504
NCT00207636

Trial Description

Summary

The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering PSA screening for prostate cancer.

Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. This educational, interactive DA will help them prepare for that discussion.

Further Study Information

Prostate cancer (CaP) is a formidable public health problem in the US and in industrialized countries worldwide. Methods for primary prevention of CaP are unknown. As a result, early detection has become a mainstay of cancer control efforts. However, there is considerable controversy regarding the efficacy of screening in reducing disease-specific mortality. In light of this uncertainty, major medical organizations, including the National Cancer Institute, currently recommend that men discuss the pros and cons of CaP screening and make individualized screening decisions with their health care providers. However, because of constraints on time during medical encounters, it is not always feasible for providers to engage in in-depth discussions regarding the complexities of this issue. Therefore, interventions to promote informed decision-making (IDM) outside of clinical settings are needed.

In this study, we propose to: (1) develop an interactive computer-based decision aid (DA) to promote IDM for CaP screening; and (2) conduct a randomized controlled worksite trial to evaluate the impact the DA intervention on employed men’s ability to make informed decisions regarding CaP. This work is designed to be responsive to recent calls for IDM interventions in community settings among diverse populations. If successful, our findings could validate the effectiveness of DAs to promote IDM for CaP and serve as a model for widespread dissemination, thus improving quality of care.

Eligibility Criteria

Inclusion Criteria:

Worksites employing at least 100 men in target age group (45-65 years old)

Exclusion Criteria:

Worksites with high turnover

Non-English speaking workers

Temporary or contract workers

Trial Contact Information

Trial Lead Organizations/Sponsors

Centers for Disease Control

Jennifer D Allen, PN MPH ScD

Principal Investigator

Jennifer D Allen, PN, MPH, ScD		Ph: 617-632-2269
		Email: jennifer_allen@dfci.harvard.edu

Elizabeth A Harden, BA		Ph: 617-632-2185
		Email: elizabeth_harden@dfci.harvard.edu

Trial Sites

U.S.A.

Massachusetts

Boston

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Jennifer D Allen, PN MPH PhD Ph: 617-632-2269

Email: jennifer_allen@dfci.harvard.edu

Elizabeth A Harden, BA Ph: 617-632-2185

Email: elizabeth_harden@dfci.harvard.edu

Jennifer D Allen, PN MPH ScD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00207636
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.