title: Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer.
abstract: BACKGROUND
  The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients' informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to β test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting.
  
  
  METHODS
  This paper concerns a pre-implementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid.
  
  
  BACKGROUND
  This protocol was approved by the Maastricht University Medical Centre (MUMC) ethics committee. The findings will be disseminated through peer-reviewed journal articles and presentations at national conferences. Findings will be used to finalise a multi-faceted implementation strategy to test the implementation of SDM and a patient decision aid in terms of cost-effectiveness, in a multicentre cluster randomised controlled trial (RCT).
  
  
  BACKGROUND
  NTR4879.
authors.affiliation: Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Wilma
authors.initials: W
authors.lastname: Savelberg
authors.affiliation: Zuyd University of Applied Sciences, Heerlen, The Netherlands.
authors.forename: Albine
authors.initials: A
authors.lastname: Moser
authors.affiliation: Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Marjolein
authors.initials: M
authors.lastname: Smidt
authors.affiliation: Department of Radiotherapy, Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Liesbeth
authors.initials: L
authors.lastname: Boersma
authors.affiliation: Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Christel
authors.initials: C
authors.lastname: Haekens
authors.affiliation: Department of Family Medicine, Maastricht University, Maastricht, The Netherlands School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands.
authors.forename: Trudy
authors.initials: T
authors.lastname: van der Weijden
mesh_terms: D001291:Attitude of Health Personnel; D001943:Breast Neoplasms / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery*; D002985:Clinical Protocols; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D015412:Mastectomy, Segmental; D009367:Neoplasm Staging; D017063:Outcome Assessment, Health Care; D010358:Patient Participation; D057240:Patient Preference; D036301:Qualitative Research; D012107:Research Design
keywords: Decision support Techniques; Patient participation; Patient preferences; Quality improvement; Shared decision making
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