Prostate CancerNCT03869216

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

A study testing Educational Shared Decision-Making Intervention in people with Prostate Cancer, run by Xavier University of Louisiana. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 40 to 69 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prostate Cancer
What is being tested?: Educational Shared Decision-Making Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 1 siteUnited States
Study dates: 17 Aug 2020to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 69 years
Men only
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Tulane Medical Center
New Orleans, Louisiana, 70112

Other trials in United States

About this study

Read the 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).

Conditions: Prostate Cancer
Being tested: Educational Shared Decision-Making Intervention
Keywords: Prostate cancer, Primary Care, PSA-screening, African American males
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Educational Shared Decision-Making InterventionBehavioural
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.

Study groups in NCT03869216
Study group	Role	What they receive
Intervention	Experimental	Patients in the intervention will receive the educational intervention Receives: Behavioral: Educational Shared Decision-Making Intervention
Usual Care	No intervention	Patients in the control arm will receive usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: One month after audio-recorded visit

Secondary outcomes (2)

Quality of Decision (QD)
The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made.
Measured: Up to 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 test.
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.
Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 202031 Dec 2023

First posted11 Mar 2019
Study start17 Aug 2020
Primary completion30 Nov 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel assignment
Masking: Single blind
Who is masked: Care provider
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03869216
Sponsor's protocol ID: IRB684-20
Other IDs: U54MD007595
Status last verified: Dec 2025
First submitted: 4 Mar 2019
Last updated: 29 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified summary of participant data for all primary and secondary outcomes measures will be made available.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men
ClinicalTrials.gov ID: NCT03869216
Acronym / sponsor ID: IRB684-20
Conditions: Prostate Cancer
Keywords: Prostate cancer, Primary Care, PSA-screening, African American males
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Xavier University of Louisiana.University, hospital or other
Collaborators: Tulane University, National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 17 Aug 2020 (actual)
Primary completion: 30 Nov 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 11 Mar 2019 (actual)
Results: Posted 29 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
Model description: Parallel assignment

Arm	Type	Receives
Intervention	Experimental	Behavioral: Educational Shared Decision-Making InterventionPatients in the intervention will receive the educational intervention
Usual Care	No intervention	–Patients in the control arm will receive usual care

Who may qualify

Ages: 40 to 69 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Educational Shared Decision-Making InterventionThe 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.	Behavioural	Intervention

Primary outcome

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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 29 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	80	60
Usual Care	81	53

Primary outcome: Shared Decision-making

Time frame: One month after audio-recorded visit. Mean (Standard Deviation). Unit: Units on a scale

Measure	Intervention n = 62	Usual Care n = 63
Value	12.54 (11.0198)	12.15 (10.4026)

Intervention vs Usual Care: Mean Difference (Final Values): 0.395 (95% CI -3.40 to 4.19), p = 0.8388, t-test, 2 sided

Population analysed: The OPTION Scale was applied only to patients who had attended the medical appointment (62 in the intervention group, and 64 in the control group). Because one recording in the control group could not be completed (the audio-recording device was damaged), only 63 recordings were evaluated in that group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 79 (0%)	0 of 79 (0%)	1 of 79
Usual Care	0 of 76 (0%)	0 of 76 (0%)	1 of 76

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified summary of participant data for all primary and secondary outcomes measures will be made available.

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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margarita Echeverri, PhD, MSc principal investigator

Xavier University of Louisiana.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Educational Shared Decision-Making Intervention in people with Prostate Cancer, run by Xavier University of Louisiana. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shared Decision-making (time frame: One month after audio-recorded visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03869216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.