Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Computer-based prostate cancer screening decision aid
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Prostate Cancer focused on measuring Computer-Assisted Decision Making, Workplace, Screening
Eligibility 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
Sites / Locations
- Dana-Farber Cancer InstituteRecruiting
Outcomes
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
Full Information
NCT ID
NCT00207636
First Posted
September 15, 2005
Last Updated
September 15, 2005
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00207636
Brief Title
Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening
Official Title
Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Computer-Assisted Decision Making, Workplace, Screening
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Computer-based prostate cancer screening decision aid
Primary Outcome Measure Information:
Title
1.Informed Decision Making
Secondary Outcome Measure Information:
Title
1.Satisfaction with Decision Making Process and Decision
Title
2.Decisional conflict
Title
*All measures assessed at baseline and follow up survey and will be completed by month 6 of year 3 of the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer D Allen, PN, MPH, ScD
Phone
617-632-2269
Email
jennifer_allen@dfci.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth A Harden, BA
Phone
617-632-2185
Email
elizabeth_harden@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer D Allen, PN MPH ScD
Organizational Affiliation
Dana-Farber Cancer Institute; Harvard School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer D Allen, PN MPH PhD
Phone
617-632-2269
Email
jennifer_allen@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth A Harden, BA
Phone
617-632-2185
Email
elizabeth_harden@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jennifer D Allen, PN MPH ScD
12. IPD Sharing Statement
Learn more about this trial
Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening
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