The impact of a patient decision aid for patients with advanced laryngeal carcinoma - a multicenter study

Purpose Patients with advanced larynx cancer face challenging treatment decisions. To address this, we developed and tested a patient decision aid (PDA), aiming to reduce decisional conflict (DC), and enhance knowledge and perceived shared decision-making (SDM). Methods In this multicenter study (ClinicalTrials.gov ID: NCT03292341, 2016-2023), a pre/post study design was used. Participants, meeting the inclusion criteria of advanced larynx cancer without distant metastasis, completed questionnaires on knowledge, DC and SDM immediately after counseling (T1) and 6 months post-treatment (T2). The intervention arm utilized the PDA (see https://beslissamen.nl/pda_launch.html?pda=tools/pda_larynx_en/story.html) before completing T1 questionnaires, while the usual care arm followed standard procedures. Between-group differences in outcomes were estimated using regression models with correction for case mix differences. Results Total DC score was significantly lower in the intervention arm (n = 46) compared to the usual care arm (n = 45) (adjusted mean difference - 32, 95% CI: -37.4; -26.1, p < 0.001). The intervention group demonstrated significantly higher overall knowledge (mean 69% correct) than the control group (mean 47% correct)(adjusted mean difference 24, 95% CI 15.3; 33.1, p < 0.001). Almost all patients in usual care (44/45, 98%) experienced clinically significant DC (CSDC, DCS > 25), compared to 89% (41/46) in the intervention arm (adjusted OR 0.25, 95%CI 0.01; 1.9) p = 0.238). Perceived SDM was significant higher in the intervention arm (mean 78.16) compared to the usual care arm (mean 70.32); however, both groups exhibited high levels. Conclusion The PDA for advanced laryngeal cancer effectively reduced decisional conflict, enhanced patients' knowledge and improved perceived SDM.Trial registrationClinicalTrials.gov ID NCT03292341, 20,151,231.Level of evidence3.