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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Educational Shared Decision-Making Intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Patient Inclusion Criteria:

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

Patient 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients in the intervention will receive the educational intervention	Behavioral: 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.
No Intervention: Usual Care; Patients in the control arm will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared decision-making	Patient-provider visits will be audio-recorded and coded for the extent of shared decision making about prostate cancer using a defined scheme. The Observing Patient Involvement (OPTION) Scale will be used for the coding. Total OPTION scale ranges from 0 to 48. Higher values mean higher patient involvement during the shared decision making process.	One month after audio-recorded visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Decision (QD)	A percentage score of the following four subscales. The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made.; Prostate Cancer Screening Knowledge (20 items): Total score ranges from 0 to 20. Higher values mean higher knowledge of prostate cancer screening.; Decision Confidence (10 items): Total score ranges from 0 to 40. Higher values mean higher confidence in the decision made.; Decisional Self-efficacy questionnaire (4 items): Total score ranges from 4 to 20. Higher values mean higher efficacy in the communication used during the shared decision encounter.; Satisfaction with Decision (6 items): Total score ranges from 6 to 30. Higher values mean higher satisfaction with the decision made.	Up to one 24 weeks after the audio-recorded visit
Preference-Congruent Decision Making	The Intention-to-Screen score ranges from 0 to 1. Score = 0 means no intention to receive the PSA test while score = 1 means intention to receive the PSA. Preference-concordant decision making will be scored as 1 (POSITIVE) for those patients with Intention-to-Screen value = 1 who actually receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did not receive it. Preference-concordant decision making will be scored as 0 (NEGATIVE) for those patients with Intention-to-Screen value = 1 who did not receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did receive it. A congruence score of 1 means congruence between patient intention and real action, while a congruence score of 0 means patient in-congruence between intention and real action.	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Participants will complete a structured questionnaire to rate the acceptability of the enrollment process, the delivery of the intervention, and their overall satisfaction with the study. The score ranges from 12 to 60. Higher scores mean higher acceptability with the intervention procedures.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Xavier University of Louisiana.
• Collaborators: Tulane University
• Investigators: Principal Investigator: Margarita Echeverri, PhD, MSc, Xavier University of Louisiana.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Primary Care; Prostate cancer; African American males; PSA-screening
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IRB684-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified summary of participant data for all primary and secondary outcomes measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No