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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
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

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

45 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
September 15, 2005
Last Updated
September 15, 2005
Sponsor
Centers for Disease Control and Prevention
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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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