Impact of a web-based treatment decision aid for early-stage prostate cancer on shared decision-making and health outcomes: study protocol for a randomized controlled trial.

backgroundAt an early stage, prostate cancer patients are often eligible for more than one treatment option, or may choose to defer curative treatment. Without a pre-existing superior option, a patient has to weigh his personal preferences against the risks and benefits of each alternative to select the most appropriate treatment. Given this context, in prostate cancer treatment decision-making, it is particularly suitable to follow the principles of shared decision-making (SDM), especially with the support of specific instruments like decision aids (DAs). Although several alternatives are available, present tools are not sufficiently compatible with routine clinical practice. To overcome existing barriers and to stimulate structural implementation of DAs and SDM in clinical practice, a web-based prostate cancer treatment DA was developed to fit clinical workflow. Following the structure of an existing DA, Dutch content was developed, and values clarification methods (VCMs) were added. The aim of this study is to investigate the effect of this DA on (shared) treatment choice and patient-reported outcomes. METHODS/

designNineteen Dutch hospitals are included in a pragmatic, cluster randomized controlled trial, with an intervention and a control arm. In the intervention group, the DA will be offered after diagnosis, and a summary of the patients' preferences, which were identified with the DA, can be discussed by the patient and his clinician during later consultation. Patients in the control group will receive information and decisional support as usual. Results from both groups on decisional conflict, treatment choice and the experience with involvement in the decision-making process are compared. Patients are requested to fill in questionnaires after treatment decision-making but before treatment is started, and 6 and 12 months later. This will allow the development of treatment satisfaction, decisional regret, and quality of life to be monitored. Clinicians from both groups will evaluate their practice of information provision and decisional support. DISCUSSION: This study will describe a web-based prostate cancer treatment DA with VCMs. The effect of this DA on the decision-making process and subsequent patient reported outcomes will be evaluated.

trial registrationThe Netherlands National Trial Register: NTR4554, registration date 1 May 2014.