Department of Surgery, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Department of Quantitative Health Sciences, Mayo Clinic, Rochester, New York, USA.
BMJ Open. 2022 Nov 17;12(11):e063895. doi: 10.1136/bmjopen-2022-063895.
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.
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.
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.
ClinicalTrials.gov Registry (NCT03766009).
乳腺癌手术护理存在社会经济差异。尽管观察到的社会经济差异的病因可能是多因素的，但患者在手术咨询期间的参与至关重要。共同决策通过解决阻碍社会经济处于不利地位的患者参与决策的障碍，可能会减少健康差异。在这项试验中，我们测试了决策辅助工具对增加社会经济处于不利地位的患者参与乳腺癌手术决策的影响。
这项多地点随机试验是通过国家癌症研究所社区肿瘤学研究计划（NCORP）的 10 个外科诊所进行的。我们计划采用逐步楔形设计，将诊所随机分配到从常规护理过渡到决策辅助工具的时间。研究参与者为年龄≥18 岁、新诊断为 0-III 期乳腺癌且计划行乳房手术的女性患者。数据收集包括基线外科医生调查、基线患者调查、外科医生-患者咨询的音频记录、随访患者调查和病历数据审查。对患者、外科医生和诊所利益相关者进行了访谈和焦点小组讨论。使用广义线性混合效应模型评估决策辅助工具在增加患者参与度方面的有效性（主要结果）。通过联合线性结构方程模型测试决策辅助干预对患者参与度的影响是否通过减轻障碍来介导。定性访谈探讨了障碍如何影响参与度，特别是对社会经济处于不利地位的女性。
本方案已获得国家癌症研究所中央机构审查委员会的批准，并获得了保密证书。我们计划通过期刊出版物和全国会议，包括 NCORP 网络，传播研究结果。我们的研究结果将推进医学决策科学的发展，有可能减少社会经济健康差异。
ClinicalTrials.gov 注册表（NCT03766009）。
