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

NCT03869216 | Completed Results

• 2 other identifiers: IRB684-20U54MD007595
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Primary Care; PSA-screening; African American males

Outcome Measures

Primary Outcomes (1)

• Shared Decision-making

  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.

  One month after audio-recorded visit

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Acceptability

  Through study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in the intervention will receive the educational intervention

Behavioral: Educational Shared Decision-Making Intervention

Usual Care

NO INTERVENTION

Patients in the control arm will receive usual care

Interventions

Educational Shared Decision-Making Intervention 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.

Intervention

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xavier University of Louisiana.: lead
• Tulane University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Significant delays in the advance of the study, were caused by events that were not under our control: Coronavirus disease (COVID19) pandemic and major Hurricanes Zeta and Ida). Because of the restrictions in the city and clinics, several participants moved out and/or did not update their contact information. To address COVID19 restrictions it was necessary to update the study protocol to conduct all activities online and have the new Institutional Review Board approvals in the clinical sites.

Results Point of Contact

• Title: Margarita Echeverri, Professor of Social and Behavioral Sciences
• Organization: Xavier University of Louisiana

mechever@xula.edu

504-520-6719

Study Officials

• Margarita Echeverri, PhD, MSc

  Xavier University of Louisiana.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The patients are the unit of randomization and physicians do not know what patients are assigned to the intervention or control arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 11, 2019
• Study Start: August 17, 2020
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 29, 2025
• Results First Posted: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access request will be reviewed by the Institutional Review Board (IRB) and principal investigators. Requestors will be required to sign a Data Access Agreement

Locations

US (1)