Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial

Jessica R Schumacher, David Zahrieh, Selina Chow, John Taylor, Rachel Wills, Bret M Hanlon, Paul J Rathouz, Jennifer L Tucholka, Heather B Neuman, Jessica R Schumacher, David Zahrieh, Selina Chow, John Taylor, Rachel Wills, Bret M Hanlon, Paul J Rathouz, Jennifer L Tucholka, Heather B Neuman

Abstract

Introduction: Socioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may reduce health disparities by addressing barriers to patient engagement in decision-making that disproportionately impact socioeconomically disadvantaged patients. In this trial, we test the impact of a decision aid on increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making.

Methods and analysis: This multisite randomised trial is conducted through 10 surgical clinics within the National Cancer Institute Community Oncology Research Program (NCORP). We plan a stepped-wedge design with clinics randomised to the time of transition from usual care to the decision aid arm. Study participants are female patients, aged ≥18 years, with newly diagnosed stage 0-III breast cancer who are planning breast surgery. Data collection includes a baseline surgeon survey, baseline patient survey, audio-recording of the surgeon-patient consultation, a follow-up patient survey and medical record data review. Interviews and focus groups are conducted with a subset of patients, surgeons and clinic stakeholders. The effectiveness of the decision aid at increasing patient engagement (primary outcome) is evaluated using generalised linear mixed-effects models. The extent to which the effect of the decision aid intervention on patient engagement is mediated through the mitigation of barriers is tested in joint linear structural equation models. Qualitative interviews explore how barriers impact engagement, especially for socioeconomically disadvantaged women.

Ethics and dissemination: This protocol has been approved by the National Cancer Institute Central Institutional Review Board, and Certificate of Confidentiality has been obtained. We plan to disseminate the findings through journal publications and national meetings, including the NCORP network. Our findings will advance the science of medical decision-making with the potential to reduce socioeconomic health disparities.

Trial registration number: ClinicalTrials.gov Registry (NCT03766009).

Keywords: Breast surgery; Breast tumours; Protocols & guidelines.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Our conceptual model is based on the theory that in order to engage in SDM, patients must have both the power to influence decision-making and knowledge about the options. Pre-consultation review of a decision can address these key conditions by preparing patients for the surgical consultation and increasing their confidence in interacting with the surgeon. However, barriers to engagement may limit the effect of the decision aid. These barriers disproportionately impact socioeconomically disadvantaged patients. SDM, shared decision-making.
Figure 2
Figure 2
Stepped-wedge study design. The effect of the decision aid on patient engagement will be evaluated as a pre/post-comparison of usual care versus the decision aid intervention arms through the stepped-wedge design. The process of implementation of the decision aid will occur over a 10-week period during which the clinic does not collect patient-level data.
Figure 3
Figure 3
Overview of data collection scheme at patient, clinic stakeholder and clinic levels.
Figure 4
Figure 4
Schematic depicting the mediating role of preparatory and interactional barriers on engagement. The dashed lines represent the test for the overall effect of whether the decision aid improves engagement through that pathway. *Effect of decision aid on barriers; + Effect of barriers on engagement.
Figure 5
Figure 5
Overview of mixed methods.

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