title: 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.
abstract: BACKGROUND
  At 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
  Nineteen 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The Netherlands National Trial Register: NTR4554, registration date 1 May 2014.
authors.affiliation: Department of Social Psychology, Tilburg University, Warandelaan 2, 5037 AB, Tilburg, The Netherlands. M.Cuypers@uvt.nl.
authors.forename: Maarten
authors.initials: M
authors.lastname: Cuypers
authors.affiliation: Department of Urology, St. Elisabeth Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands. R.Lamers@elisabeth.nl.
authors.forename: Romy E D
authors.initials: RE
authors.lastname: Lamers
authors.affiliation: Department of Urology, St. Elisabeth Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands. P.Kil@elisabeth.nl.
authors.forename: Paul J M
authors.initials: PJ
authors.lastname: Kil
authors.affiliation: Department of Medical Psychology and Clinical Psychology, CoRPS - Center of Research on Psychology in Somatic Diseases, Tilburg University, Warandelaan 2, 5037 AB, Tilburg, The Netherlands. L.vd.Poll@uvt.nl.|Comprehensive Cancer Centre Netherlands South, Zernikestraat 29, 5612 HZ, Eindhoven, The Netherlands. L.vd.Poll@uvt.nl.
authors.forename: Lonneke V
authors.initials: LV
authors.lastname: van de Poll-Franse
authors.affiliation: Department of Social Psychology, Tilburg University, Warandelaan 2, 5037 AB, Tilburg, The Netherlands. MariekedeVries@uvt.nl.|Department of Social Psychology, Tilburg Institute for Behavioral Economics Research (TIBER), Tilburg University, Warandelaan 2, 5037 AB, Tilburg, The Netherlands. MariekedeVries@uvt.nl.
authors.forename: Marieke
authors.initials: M
authors.lastname: de Vries
mesh_terms: D002755:Choice Behavior; D002985:Clinical Protocols; D003220:Conflict, Psychological; D003661:Decision Support Techniques; D004644:Emotions; D006801:Humans; D020407:Internet; D008297:Male; D009367:Neoplasm Staging; D009426:Netherlands; D010358:Patient Participation; D018579:Patient Selection; D011237:Predictive Value of Tests; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000628:therapy*; D012017:Referral and Consultation; D012107:Research Design; D013813:Therapy, Computer-Assisted; D016896:Treatment Outcome