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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00207636
• Other study ID #: CDC-NCCDPHP-2504
• Status: Unknown status
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: September 15, 2005
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: Jennifer D Allen, PN, MPH, ScD
• Phone: 617-632-2269
• Email: jennifer_allen[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 1120
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Computer-based prostate cancer screening decision aid

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Informed Decision Making
Secondary	1.Satisfaction with Decision Making Process and Decision
Secondary	2.Decisional conflict
Secondary	*All measures assessed at baseline and follow up survey and will be completed by month 6 of year 3 of the study