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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Centers for Disease Control and Prevention.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207636
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centers for Disease Control and Prevention
  Purpose
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 1.Informed Decision Making

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1120
Study Start Date: December 2004
Estimated Study Completion Date: September 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207636


Contacts
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

Locations
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         
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Jennifer D Allen, PN MPH ScD Dana-Farber Cancer Institute; Harvard School of Public Health
  More Information

ClinicalTrials.gov Identifier: NCT00207636     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-2504
First Submitted: September 15, 2005
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
Last Verified: September 2005

Keywords provided by Centers for Disease Control and Prevention:
Computer-Assisted Decision Making
Workplace
Screening

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases