Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Department of Medicine, University of Toronto, Toronto, ON, Canada.
BMC Cancer. 2019 Sep 5;19(1):884. doi: 10.1186/s12885-019-6099-x.
Population-based studies suggest that emergency department visits and hospitalizations are common among patients receiving chemotherapy and that rates in routine practice are higher than expected from clinical trials. Chemotherapy-related toxicities are often predictable and, consequently, acute care visits may be preventable with adequate treatment planning and support between visits to the cancer centre. We will evaluate the impact of proactive telephone-based toxicity management on emergency department visits and hospitalizations in women with early stage breast cancer receiving chemotherapy.
In this pragmatic covariate constraint-based cluster randomized trial, 20 centres in Ontario, Canada are randomly allocated to either proactive telephone toxicity management (intervention) or routine care (control). The primary outcome is the cluster-level mean number of ED + H visits per patient evaluated using Ontario administrative healthcare data. Participants are all patients with early stage (I-III) breast cancer commencing adjuvant or neo-adjuvant chemotherapy at participating institutions during the intervention period. At least 25 patients at each centre participate in a patient reported outcomes sub-study involving the collection of standardized questionnaires to measure: severity of treatment toxicities, self-care, self-efficacy, quality of life, and coordination of care. Patients participating in the patient reported outcomes (PRO) sub-study are asked to provide written consent to link their PRO data to administrative data. Unit costs will be applied to each per person resource utilized, and a total cost per population and patient will be generated. An incremental cost-effectiveness analysis will be undertaken to compare the incremental costs and outcomes between the intervention and control groups from the health system perspective.
This study evaluates the effectiveness of a proactive toxicity management intervention in a routine care setting. The use of administrative healthcare data to evaluate the primary outcome enables an evaluation in a real world setting and at a much larger scale than previous studies.
Clinicaltrials.gov , NCT02485678. Registered 30 June 2015.
基于人群的研究表明，在接受化疗的患者中，急诊科就诊和住院治疗较为常见，且在常规治疗中，就诊率高于临床试验预期。化疗相关毒性通常是可预测的，因此，通过充分的治疗计划和癌症中心就诊间的支持，可预防急性护理就诊。我们将评估主动电话毒性管理对接受化疗的早期乳腺癌女性的急诊科就诊和住院治疗的影响。
在这项基于实用性协变量约束的集群随机试验中，加拿大安大略省的 20 个中心被随机分配至主动电话毒性管理（干预组）或常规护理（对照组）。使用安大略省的医疗保健管理数据评估的主要结局为每例患者的急诊就诊和就诊后住院治疗的平均就诊次数。参与者均为参与机构在干预期间开始辅助或新辅助化疗的早期（I-III 期）乳腺癌患者。每个中心至少有 25 名患者参与涉及收集标准化问卷的患者报告结局子研究，以测量：治疗毒性的严重程度、自我护理、自我效能、生活质量和护理协调。参与患者报告结局（PRO）子研究的患者被要求书面同意将其 PRO 数据与管理数据相链接。将对每个人利用的资源进行单位成本核算，并生成每个人群和患者的总成本。将从卫生系统角度开展增量成本效益分析，以比较干预组和对照组的增量成本和结局。
本研究评估了在常规护理环境中主动毒性管理干预的有效性。使用医疗保健管理数据评估主要结局可在现实环境中并以比以往研究更大的规模进行评估。
Clinicaltrials.gov，NCT02485678。注册于 2015 年 6 月 30 日。
