Abstract
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.
CONCLUSION
The PDA for advanced laryngeal cancer effectively reduced decisional conflict, enhanced patients' knowledge and improved perceived SDM.
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.
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).
TRIAL REGISTRATION
ClinicalTrials.gov ID NCT03292341, 20,151,231.