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Clinical Trials/NCT03869216
NCT03869216
Completed
N/A

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

Xavier University of Louisiana.1 site in 1 country161 target enrollmentAugust 17, 2020
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Xavier University of Louisiana.
Enrollment
161
Locations
1
Primary Endpoint
Shared Decision-making
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
August 17, 2020
End Date
December 31, 2023
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Shared Decision-making

Time Frame: One month after audio-recorded visit

The Observing Patient Involvement (OPTION) Scale was used for the coding of the SDM. The total OPTION scale ranges from 0 to 48. Higher values on the scale mean higher patient involvement in the decision-making process.

Secondary Outcomes

  • Quality of Decision (QD)(Up to 24 weeks after the audio-recorded visit)
  • Preference-Congruent Decision Making(Through study completion, an average of 1 year)

Study Sites (1)

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