Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men

NCT ID: NCT03869216

Last Updated: 2025-12-29

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

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2023-12-31

Brief Summary

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This behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (PSA)-based screening for prostate cancer among African American males. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care.

Detailed Description

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The 2018 U.S. Preventive Services Task Force (USPSTF) final recommendation states that male patients and their providers engage in a shared-decision making process about the benefits and harms of PSA-based screening. As characterized by the USPSTF, these conversations are particularly important for African American men given increased ambiguity due to the lack of PSA-based research specific to this population and increased risk of prostate cancer mortality attributed to late stage at diagnosis and more aggressive prostate cancer phenotypes seen in African American men.

The goal of this randomized behavioral clinical trial is to advance the translation path of implementing the decision-making process in clinical encounters by evaluating the efficacy of an educational intervention for African American males to increase shared decision making about PSA-screening versus usual care. The intervention will use multimedia educational training materials to increase understanding of prostate cancer, PSA-based screening, and shared decision making among patients and their primary care providers (PCPs).

Conditions

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Prostate Cancer

Keywords

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Prostate cancer Primary Care PSA-screening African American males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
The patients are the unit of randomization and physicians do not know what patients are assigned to the intervention or control arm.

Study Groups

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Intervention

Patients in the intervention will receive the educational intervention

Group Type EXPERIMENTAL

Educational Shared Decision-Making Intervention

Intervention Type BEHAVIORAL

The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.

Usual Care

Patients in the control arm will receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational Shared Decision-Making Intervention

The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Receiving care at the clinical sites
* Identify as African American male
* Ages 40-69 years old

Exclusion Criteria

* Personal history of prostate cancer at the time of consent
* Cognitive impairment that would interfere with participation in the study
* Unable to complete any aspect of the intervention within the specified time limit
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tulane University

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Xavier University of Louisiana.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margarita Echeverri, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Xavier University of Louisiana.

Locations

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Tulane Medical Center

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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U54MD007595

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB684-20

Identifier Type: -

Identifier Source: org_study_id