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

NCT ID: NCT00207636

Last Updated: 2025-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

812 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering prostate-specific antigen (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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Distribution of printed materials

Group Type NO_INTERVENTION

No interventions assigned to this group

Computer Assisted Decision making tool

The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.

Group Type EXPERIMENTAL

Computer Assisted Decision making tool

Intervention Type BEHAVIORAL

The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.

Interventions

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Computer Assisted Decision making tool

The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer D Allen, PN MPH ScD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute; Harvard School of Public Health

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Allen JD, Othus MK, Hart A Jr, Tom L, Li Y, Berry D, Bowen D. A randomized trial of a computer-tailored decision aid to improve prostate cancer screening decisions: results from the Take the Wheel trial. Cancer Epidemiol Biomarkers Prev. 2010 Sep;19(9):2172-86. doi: 10.1158/1055-9965.EPI-09-0410. Epub 2010 Aug 17.

Reference Type BACKGROUND
PMID: 20716619 (View on PubMed)

Other Identifiers

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CDC-NCCDPHP-2504

Identifier Type: -

Identifier Source: org_study_id

NCT00137618

Identifier Type: -

Identifier Source: nct_alias

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