PDA Impact in Advanced Larynx Cancer | 127 5 Materials and Methods Study sample and design This is a multicenter study with a before-after design study (ClinicalTrials.gov Identifier: NCT03292341). The objective of the current study was to compare outcomes after implementation of the PDA to those in usual care. For data collection, the present study therefore utilized comparable methodology as the previously published study19. The sample size was based on an assumed decrease in decisional conflict with a standardized mean difference of 0.6, for which 45 patients per group were needed to achieve 80% power with an alpha of 0.0520. Patients were recruited in six Dutch head and neck centers between 2016-2023. Eligible patients were >18 years, diagnosed with of primary T3-T4 laryngeal cancer and Dutch proficient. Patients without choice in treatment due to medical conditions, or recurrent disease were excluded. Patients meeting inclusion criteria were approached after the multidisciplinary tumor board (MDT) discussion. After signing informed consent, they received baseline questionnaires (T1) following their outcome interview. The physician (head and neck surgeon or radiation oncologist) simultaneously completed SDM-Q-Doc after consultation. The follow-up questionnaire (T2) was sent through mail, six months posttreatment (Figure 1). The patient questionnaires for T1 and T2 included the Decisional Conflict Scale15,21, SDM-Q-922–24, Control Preference Scale (CPS)9, and a study-specific knowledge test. The T1 questionnaire contained additional personal situation questions (see supplements). As this study follows a pre/post design, patients in the usual care arm were enrolled prior to PDA implementation, while subsequent patients were included in the intervention arm. For a visual representation, refer to Appendix A. In the intervention arm, patients received extra information about the PDA and contact details of the main researcher (A.N.H.) for further queries. All patients were given a uniform instruction form outlining how to access the PDA website, including helpful tips like browser compatibility suggestions and the importance of enabling sound. Those without home computer access could use a consultation room computer, with the researcher nearby for assistance while ensuring privacy.
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