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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

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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 preimplementation 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.


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