Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD)

Abstract

Background: Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled.

Methods: The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation.

Results: Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively).

Conclusions: DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.

Trial registration: ClinicalTrials.gov NCT03103321.

Keywords: decision aids; knowledge; prostate cancer; shared decision-making.

Conflict of interest statement

Conflicts of Interest

Dr. Morris is a non-compensated consultant to Bayer, Novartis, Advanced Accelerator Applications, Janssen, Lantheus. Dr. Morris is a compensated consultant to ORIC, Curium, Athenex, NCCN, and Exelixis. Dr. Morris also receives institutional funding for clinical trials from: Bayer, Endocyte, Progenics, Corcept, Roche/Genentech, Celgene/BMS, and. Janssen. None of Dr. Morris’s disclosures are related to this work. Dr. Paskett is the MPI on a grant to her institution form Merck Foundation and another from Pfizer. Dr. Paskett also receives grant funding to her institution form the Breast Cancer Research Foundation. None of Dr. Paskett’s disclosures are related to this work.

© 2021 American Cancer Society.

Figures

Figure 1.

Site- and Patient-level Recruitment, Randomization, and Flow for Cancer Care Delivery Research, 2×2 Factorial, Cluster-randomized Trial (Alliance A141902CD). c = Number of sites (clusters; n = Number of patients; DA = Decision AID * Reasons for why a site did not meet the eligibility criteria were not captured as part of the protocol. ₸ A replacement site for a non-accruing site joined after study commencement. ‡ Three patientes received both pre- and during-consultation decision aids. † Patient did not complete the 12-item knowledge about prostate cancer treatments questionnaire.

Figure 2.

Distribution of knowledge scores by study arm among 155 patient-participants at 15 sites who completed (or partially completed) the 12-item questionnaire.

Figure 3.

Average knowledge scores (proportion correct) for each site and according to the factorial cells of the trial.