Clinical Trials Directory

Trials / Completed

CompletedNCT00207636

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

Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
812 (actual)
Sponsor
Centers for Disease Control and Prevention · Federal
Sex
Male
Age
45 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALComputer Assisted Decision making toolThe intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.

Timeline

Start date
2004-12-01
Primary completion
2009-08-01
Completion
2009-08-01
First posted
2005-09-21
Last updated
2025-01-14
Results posted
2025-01-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00207636. Inclusion in this directory is not an endorsement.