Randomized pilot trial of pre-visit patient education as preparation for decision making in newly diagnosed prostate cancer (PrepDM).

Abstract

361 Background: Men with newly diagnosed prostate cancer (PCa) face preference-sensitive choices among currently available alternatives in management. High-quality decisions require understanding options, weighing trade-offs, and aligning choices with personal values. We evaluated whether brief pre-visit education improves patients’ Preparation for Decision Making (PrepDM). Methods: This was a single-center, 1:1 randomized pilot trial of men with biopsy-proven prostate cancer allocated to intervention (in which patients were provided curated educational material/videos before the follow-up visit) or usual care. Baseline demographics and tumor characteristics were collected; continuous and categorical variables were compared with Wilcoxon rank sum and Fisher’exact /Chi-square tests, respectively. The primary outcome was the PrepDM total score (10 items, each 1-5; range 1-50), assessing overall patient degree of strategy understanding and preparation. Secondary outcomes were item-level scores. Analyses were intention-to-treat. Group differences used Wilcoxon rank-sum with Hodges-Lehmann (HL) estimates; item-level multiple comparison testing was controlled with Benjamini-Hochberg FDR (q-values). Results: Fifty-two participants were randomized (26/arm). Median age was 70 years; median PSA 7.2 ng/dL; median prostate volume 42 cc; ISUP GG1/GG2/≥GG3 were 27%/37%/36%. Cohorts were comparable at baseline with no detectable differences in race/ethnicity, PSA, Gleason grade group, prostate volume, BMI, or age. The intervention increased overall preparation compared to control (total score difference: +6 points, 95%CI +2 to +10; p=0.002). After FDR adjustment, 7/10 items favored intervention: helping organizing thoughts (+1; q=0.006); knowing the decision depends on what matters most (+1; q=0.02); deciding desired involvement (+1; q=0.02); identifying questions (+1; q=0.03); preparing to talk about what matters most (+1; q=0.04); recognizing a decision is needed (+1;q=0.041); and weighing pros/cons (+1; q=0.045). Items on preparing for a follow-up visit (q=0.08), making a better decision (q=0.11), and prioritizing which pros/cons are most important (q=0.11) were not significant. Conclusions: Brief pre-visit patient education improved preparation for decision making, supporting shared decision-making and patient empowerment in prostate cancer care. Larger multicenter trials should confirm effectiveness and assess downstream outcomes (decisional conflict, decision quality, and satisfaction/regret).