Trial results for a behavioral study on fostering shared decision-making about Prostate Cancer screening were posted on ClinicalTrials.gov on 2025-12-29, involving 161 participants.
Background
Prostate cancer is a significant health concern, particularly among African American men who face higher incidence and mortality rates compared to other racial groups. Prostate-specific antigen (PSA)-based screening for prostate cancer is a complex decision, with potential benefits in early detection but also risks of overdiagnosis and overtreatment. Shared decision-making, where patients and clinicians collaboratively make healthcare decisions, is crucial for ensuring that screening choices align with individual patient values and preferences, especially in populations where health disparities are prominent.
Trial design
This completed behavioral clinical trial, designated as Phase NA, enrolled 161 participants to assess an educational intervention for Prostate Cancer screening. The study aimed to increase shared decision-making about PSA-based screening among African American men. Participants were randomized, with half receiving a multimedia educational intervention and the other half receiving usual care. Key outcomes assessed included Shared Decision-making, Quality of Decision (QD), Acceptability, and Preference-Congruent Decision Making.
Key results
The trial results included several key measurements and analyses comparing the intervention group to usual care:
- For Shared Decision-making, the intervention group had a mean score of 12.54 (Standard Deviation 11.0198), compared to 12.15 (Standard Deviation 10.4026) in the usual care group. The mean difference was 0.395 (95.0% CI: -3.4 to 4.19), with a p-value of 0.8388.
- Regarding Quality of Decision (QD), the intervention group showed a mean of 82.23 (Standard Deviation 13.503), versus 80.45 (Standard Deviation 13.925) for usual care. The mean difference was 1.781 (95.0% CI: -3.35 to 6.91), with a p-value of 0.4929.
- For Acceptability, the intervention group had a mean score of 42.43 (Standard Deviation 5.318), while the usual care group had 43.17 (Standard Deviation 4.590). The mean difference was -0.735 (95.0% CI: -2.58 to 1.11), with a p-value of 0.4312.
- In terms of Preference-Congruent Decision Making, one measurement reported 36 participants in the intervention group and 40 in the usual care group. Another measurement reported 24 participants in the intervention group and 13 in the usual care group. The difference in proportions was -0.1548 (95.0% CI: -0.342 to 0.033), with a p-value of 0.1216.
All reported p-values suggest no statistically significant difference between the intervention and usual care groups for these outcomes.
What this means
The results indicate that the multimedia educational intervention did not significantly improve shared decision-making, quality of decision, or acceptability of prostate cancer screening decisions among African American men when compared to usual care. While the intervention aimed to enhance patient engagement in screening discussions, the statistical analyses did not demonstrate a significant benefit across the measured outcomes. This suggests that further research or alternative approaches may be needed to effectively foster shared decision-making in this population for prostate cancer screening.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03869216, titled "Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men", were posted on 2025-12-29 on clinicaltrials.gov.