Clinical trial NCT03869216: Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men
Official title: Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Primary Care
PSA-screening
African American males
Lead sponsor: Xavier University of Louisiana.
Sponsor class: OTHER
Collaborators: name: Tulane University
First posted: 2019-03-11
Enrollment: 161
Sex: MALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Shared decision-making
timeFrame: One month after audio-recorded visit
Secondary outcomes:
measure: Quality of Decision (QD)
timeFrame: Up to one 24 weeks after the audio-recorded visit
measure: Preference-Congruent Decision Making
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Acceptability
timeFrame: Through study completion, an average of 1 year
Locations:
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
Study officials:
affiliation: Xavier University of Louisiana.
name: Margarita Echeverri, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: