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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Centers for Disease Control and Prevention.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207636
First received: September 15, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 15, 2005
September 15, 2005
December 2004
Not Provided
1.Informed Decision Making
Same as current
No Changes Posted
  • 1.Satisfaction with Decision Making Process and Decision
  • 2.Decisional conflict
  • *All measures assessed at baseline and follow up survey and will be completed by month 6 of year 3 of the study
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Prostate Cancer
Behavioral: Computer-based prostate cancer screening decision aid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1120
September 2007
Not Provided

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
Male
45 Years to 65 Years
No
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
 
NCT00207636
CDC-NCCDPHP-2504
Not Provided
Not Provided
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Jennifer D Allen, PN MPH ScD Dana-Farber Cancer Institute; Harvard School of Public Health
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP