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

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Computer Assisted Decision making tool

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00207636

CDC-NCCDPHP-2504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 812 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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812 participants in 2 patient groups

Control

No Intervention group

Description:

Distribution of printed materials

Computer Assisted Decision making tool

Experimental group

Description:

The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.

Treatment:

Behavioral: Computer Assisted Decision making tool