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Sponsored by: |
Centers for Disease Control and Prevention |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00207636 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Behavioral: Computer-based prostate cancer screening decision aid |
Phase III |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04 |
Estimated Enrollment: | 1120 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer D Allen, PN, MPH, ScD | 617-632-2269 | jennifer_allen@dfci.harvard.edu |
Contact: Elizabeth A Harden, BA | 617-632-2185 | elizabeth_harden@dfci.harvard.edu |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Jennifer D Allen, PN MPH PhD 617-632-2269 jennifer_allen@dfci.harvard.edu | |
Contact: Elizabeth A Harden, BA 617-632-2185 elizabeth_harden@dfci.harvard.edu | |
Principal Investigator: Jennifer D Allen, PN MPH ScD |
Principal Investigator: | Jennifer D Allen, PN MPH ScD | Dana-Farber Cancer Institute; Harvard School of Public Health |
Study ID Numbers: | CDC-NCCDPHP-2504 |
Study First Received: | September 15, 2005 |
Last Updated: | September 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00207636 History of Changes |
Health Authority: | United States: Federal Government |
Computer-Assisted Decision Making Workplace Screening |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |