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

BackgroundThe 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/designThis 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 disseminationThis 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 numberNTR4879.

The Impact of Radiation Oncologists on the Early Adoption of Hypofractionated Radiation Therapy for Early-Stage Breast Cancer

“…These strategies must also consider the individual providers and their beliefs and biases. Efforts to reduce provider bias could potentially include improved patient or physician education (49) and implementation of shared decision-making tools (50,51). Reimbursement reform represents a clear but complex measure that has the capacity to influence patterns of care.…”

Racial and Ethnic Differences in Prostate Cancer Survivors’ Perceived Engagement in Treatment Decision-Making

“…This includes patients and physicians having a shared understanding of the problem, patients being fully informed of treatment options and the risks and benefits, and patients and physicians making treatment decisions based on clinical evidence and patients’ values and preferences [10,11]. Patients who engage in shared decision-making with their physicians report better understanding of treatment options [11–16], higher confidence in decisions made [15,16], higher treatment compliance [16], greater satisfaction with care/decision [16], and better quality of life [17]. Alternatively, the lack of patient involvement in treatment decision-making has been linked with anxiety, dissatisfaction with care, and decision regret [18–20].…”

“…These groups experience greater challenges, as cultural as well as linguistic factors may affect their interactions with the medical environment [21]. There is increasing evidence that many patients want to be involved in treatment decisions [15,25]; however, non-cancer studies indicate that racial/ethnic minorities report less involvement in treatment decision-making [26]. In this study, we expand our understanding of shared decision-making in a multiethnic and multilingual population of prostate cancer survivors by exploring racial and ethnic differences in (1) their perception of their doctors requesting their engagement in decision-making, and (2) their self-reported involvement in treatment decision-making.…”

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“…31 Efforts to reduce provider bias could potentially include the increased use of multidisciplinary clinics, improved patient or physician education, 22 or implementation of shared decision making tools. 32 Shared decision aids have been shown to increase patient knowledge about surgical treatment options in early-stage breast cancer 33 and when used in a randomized trial setting, have been shown to increase the rate of breast conservation from 76% to 94%. 34 Multi-disciplinary tumor board conferences have been reported to Median Odds Ratio of provider increase recommendations for breast conservation.…”