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209 Summary and general discussion 11 were designed as statements and required a tradeoff between treatment specific aspects (e.g.‘I fear surgery’(reason for radiotherapy) versus‘I do not fear surgery’(reason for surgery)). To test the effectiveness of this newly developed DA, and to measure the level of implementation in clinical care, a cluster randomized controlled trial (RCT) was set up ( Chapter 5 ). Within the Prostate Cancer Patient Centered Care (PCPCC) trial, eighteen Dutch hospitals were randomized to either include the DA during treatment counseling or to provide counseling as usual. Health care providers from the trial’s intervention arm were invited to evaluate working with the DA, care providers in the control arm evaluated usual information routines. Patients who were newly diagnosed with Pca in one of the participating hospitals were invited to complete questionnaires after treatment was chosen (but before treatment started), and 6 and 12 months later. Log data from the DA and national cancer registry data were used to determine the level of implementation of the DA. The primary outcome measure of the PCPCC trial was patient reported decisional conflict, as it was hypothesized that including a DA during treatment counseling would lower decisional conflict. Secondary outcomes were patient satisfaction, preparation for decision-making, knowledge, and decisional regret. As previous studies found anxiety and depression symptoms to be common in Pca patients, in particular for patients who consider postponing immediate curative treatment by means of AS, we measured these symptoms (HADS) across all timepoints and included them in further analyses as covariate. Patient-reported decision process parameters of the PCPCC trial, measured immediately after decision-making, were examined in Chapter 6 . A total of 382 patients (DA arm, n =273; control arm, n =109) were enrolled in the trial, of which 336 participants (88%) filled out the first post-decision questionnaire. The levels of decision involvement and decisional conflict were comparable between patients from both trial arms. Patients with a DA felt more knowledgeable but scored equally well on a Pca knowledge test as patients from the control arm. Small, statistically significant negative effects were found on satisfaction with information and preparation for decision-making. A preference for a DA in print over online and depression and anxiety symptoms were negatively associated with satisfaction and conflict scores in the DA arm. To assess regret, treatment satisfaction, and information satisfaction after Pca treatment was completed, participants in the PCPCC trial received follow-up questionnaires 6 months (n=336, response 92%) and 12 months (n=308, response 95%) after their initial treatment decision ( Chapter 7 ). One year after treatment for Pca was chosen, most respondents reported very little regret about their decision and were satisfied with their

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