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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869216
• Other study ID #: IRB684-20
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Xavier University of Louisiana.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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.

Locations

Country	Name	City	State
United States	Tulane Medical Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Xavier University of Louisiana.	Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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