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Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer
  1. Wilma Savelberg1,
  2. Albine Moser2,
  3. Marjolein Smidt1,
  4. Liesbeth Boersma3,
  5. Christel Haekens1,
  6. Trudy van der Weijden4,5
  1. 1Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands
  2. 2Zuyd University of Applied Sciences, Heerlen, The Netherlands
  3. 3Department of Radiotherapy, Maastricht University Medical Center, Maastricht, The Netherlands
  4. 4Department of Family Medicine, Maastricht University, Maastricht, The Netherlands
  5. 5School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands
  1. Correspondence to Dr Wilma Savelberg; w.savelberg{at}


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/design 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.

Ethics and dissemination 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).

Study registration number NTR4879.

  • Shared decision making
  • Quality improvement
  • Patient preferences
  • Patient participation
  • Decision support Techniques

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:

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