15250-m-cuypers

134 Chapter 7 to patients from the control group, and that these treatment choices were more often driven by patient-preference rather than doctor-preference (31). However, in contrast to what was hypothesized, no beneficial effects from the DA on decisional conflict, information satisfaction, or preparation for decision-making were found immediately after treatment decision-making (32). Moreover, the DA was evaluated less positively by patients with anxious and depressive symptoms (32). Since Feldman-Stewart et al. (28) found late effects from the VCEs included in their DA, we are interested in possible long-term effects from the current DA. Next to decisional regret, as our primary long-term outcome, we included patient- reported satisfaction with treatment and information as secondary outcome. We hypothesizethat sincetheDAevaluatedall treatmentoptions, includingtheir advantages and disadvantages, patients´expectations about treatment results will be more realistic, resulting in low regret and high treatment satisfaction (33, 34). Furthermore, in line with this hypothesis, and Feldman-Stewart´s finding of potential late DA effects, we aim to evaluate the DA effect on information satisfaction at follow-up. METHODS Design The Prostate Cancer Patient Centered Care (PCPCC) trial was set up as a cluster randomized controlled trial, with eighteen Dutch hospitals randomized to either include the DA into treatment counseling, or to provide information and counseling as usual. Randomization at hospital level was chosen to avoid contamination of usual counseling with components of the DA. The regional Medical Ethics Review Board waived the need for formal ethical approval (reference: NW2014-03), and the study protocol was approved by participating hospitals. The study was pre-registered in the Dutch Trial Register (NTR4554) (29). Participants and procedure All patients newly diagnosed with localized low or intermediate risk prostate cancer (T1–T2N0M0), and a minimum of two treatment alternatives (including AS), were eligible for participation (35). Exclusion criteria were mental or cognitive impairment, or inability to complete a questionnaire in Dutch. Patients were recruited at diagnosis, and informed that the topic of the study was to evaluate information provision and treatment decision-making in Pca care. On the consent form, patients indicated the date of the subsequent consultation during which the treatment decision was planned to be finalized. The first questionnaire was sent after this indicated date (T1). Follow-