106 | Chapter 4 Materials and Methods Study sample and design We conducted a multicenter prospective before-after design study (ClinicalTrials.gov Identifier: NCT03292341), investigating the impact of an online patient decision aid for advanced laryngeal cancer patients facing curative treatment decisions21. Here we describe the data of the usual care arm (the “before” arm). Six Dutch head and neck centers participated in this study (Netherlands Cancer Institute, MAASTRO Clinic, University Medical Center Utrecht, University Medical Center Groningen, Amsterdam University Medical Center, and Radboud University Medical Center). Data were collected between March 2016 and February 2023. Patients were eligible for participation if they were ≥ 18 years of age, diagnosed with primary T3N0M0, T3N+M0, T4N0M0 or T4N+M0 larynx cancer, who were potential candidates for a total laryngectomy or (chemo)radiation, proficient in the Dutch language, and able and willing to sign informed consent. Exclusion criteria were: not having an actual treatment choice (due to contra-indications or other medical reasons), candidates for partial laryngectomy and recurrent disease. Patients were included after being discussed in the multidisciplinary tumor board (MDT) and if they met the inclusion criteria. They were provided with full study details and had the possibility to ask questions about the study to the researcher. Included patients all signed informed consent. Counseling was mostly done by the head and neck surgeon (Otorhinolaryngologist) (table 1) although most patients were also seen by a radiation oncologist and often a medical oncologist, even when treated surgically. After this counseling consultation, organized according to routine local protocol they received the baseline questionnaires (T1) about their tumor and the suggested treatment option. Their consulting physician also filled in a questionnaire (SDM-Q-Doc). Patients were invited to fill in the follow-up questionnaire (T2) six months after the end of treatment and disease-free (figure 1). The patient questionnaires at T1 and T2 were identical, with the only difference being that T2 did not again include the sociodemographic questionnaire. The questionnaires consisted of: Decisional Conflict Scale16, SDM-Q-922, Control Preference Scale23 and a study-specific knowledge test.
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