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NCT03869216

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

Completed NA Results posted Last updated 29 December 2025
What this trial tests

NA trial testing Educational Shared Decision-Making Intervention in Prostate Cancer in 161 participants. Completed in 31 December 2023.

Timeline
17 August 2020
Primary endpoint
30 November 2023
31 December 2023

Quick facts

Lead sponsorXavier University of Louisiana.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment161
Start date17 August 2020
Primary completion30 November 2023
Estimated completion31 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Xavier University of Louisiana.

Who can join

Adults 40 to 69, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Shared Decision-making Primary · 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.

GroupValue95% CI
Intervention12.54± 11.0198
Usual Care12.15± 10.4026
Quality of Decision (QD) Secondary · Up to 24 weeks after the audio-recorded visit

The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made.

GroupValue95% CI
Intervention82.23± 13.503
Usual Care80.45± 13.925
Acceptability Secondary · Through study completion, an average of 1 year

Participants complete a structured questionnaire to rate the acceptability of the enrollment process, study procedures, and their overall satisfaction with the study. The score ranges from 10 to 50. Higher scores mean higher acceptability of study procedures.

GroupValue95% CI
Intervention42.43± 5.318
Usual Care43.17± 4.590
Preference-Congruent Decision Making Secondary · Through study completion, an average of 1 year

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

Participants with Congruence Score = 1
GroupValue95% CI
Intervention36
Usual Care40
Participants with Congruence Score = 0
GroupValue95% CI
Intervention24
Usual Care13

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Racial disparity in prostate cancer: an outlook in genetic and molecular landscape.
    Kaushal JB, Raut P, Muniyan S, Siddiqui JA, et al · · 2024 · cited 4× · PMID 38902476 · DOI 10.1007/s10555-024-10193-8
  2. Fostering shared decision-making about prostate cancer screening among African American men patients and their primary care providers: a randomized behavioral clinical trial.
    Echeverri M, Felder K, Anderson D, Apantaku E, et al · · 2022 · cited 3× · PMID 35964061 · DOI 10.1186/s13063-022-06605-1

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Xavier University of Louisiana. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03869216.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing