Clinical Pharmacy, University of Michigan, Ann Arbor, Michigan, USA
Clinical Pharmacy, University of Michigan, Ann Arbor, Michigan, USA.
BMJ Open. 2024 Feb 13;14(2):e081375. doi: 10.1136/bmjopen-2023-081375.
Targeted oral anticancer agents (OAAs) are increasingly used to treat cancer, including haematological malignancies and ovarian cancer, but they can cause serious symptomatic side effects such as arrhythmias, hypertension, and hyperglycaemia. Unaddressed OAA symptoms or inadequately managed symptoms may also lead to unnecessary and unscheduled healthcare use that decreases patient quality of life and financially burdens both patients and the healthcare system. Limited information is available about patient symptoms, self-management behaviours, and use of healthcare services over time while taking targeted OAAs, but is needed to ensure successful OAA therapy. The primary objective is to understand patient experiences and behaviours on initiating targeted OAA, and elicit cancer care clinicians' (ie, physicians, advanced practice practitioners, nurses, and pharmacists) perspectives on supporting patients during therapy. Study results will inform comprehensive and realistic interventions that minimise disruptions to therapy while maximising quality of life.
We will conduct a remote single-arm, convergent-parallel mixed-methods cohort study within a large academic medical centre. A minimum of 60 patients will be enrolled. Patients will complete several validated patient-reported outcome measures at six timepoints over 6 months. Mixed-effects logistic regression will be used to predict the primary binary outcome of unscheduled healthcare use by patient self-efficacy for symptom self-management. Semistructured interviews will be conducted with patients and clinicians and thematically analysed. Triangulated quantitative and qualitative results will be reported using cross-case comparison joint display.
This study protocol is approved by the Institutional Review Board of University of Michigan Medical School (IRBMED). Study results will be published in peer-reviewed journals, presented at conferences, and disseminated to study participants.
靶向口服抗癌药物（OAAs）越来越多地用于治疗癌症，包括血液系统恶性肿瘤和卵巢癌，但它们会引起严重的症状性副作用，如心律失常、高血压和高血糖。未解决的 OAA 症状或管理不当的症状也可能导致不必要的和非计划的医疗保健使用，从而降低患者的生活质量，并给患者和医疗保健系统带来经济负担。关于患者在服用靶向 OAAs 时的症状、自我管理行为和医疗保健服务使用情况的信息有限，但为了确保成功的 OAA 治疗，这些信息是必需的。主要目标是了解患者在开始使用靶向 OAAs 时的体验和行为，并了解癌症护理临床医生（即医生、高级实践从业者、护士和药剂师）在治疗期间支持患者的观点。研究结果将为综合和现实的干预措施提供信息，最大限度地减少治疗中断，同时最大限度地提高生活质量。
我们将在一家大型学术医疗中心内进行一项远程、单臂、收敛-平行混合方法队列研究。将招募至少 60 名患者。患者将在 6 个月内的 6 个时间点完成几项经过验证的患者报告的结果测量。混合效应逻辑回归将用于预测非计划医疗保健使用的主要二项结果，该结果由患者对症状自我管理的自我效能感决定。将对患者和临床医生进行半结构式访谈，并进行主题分析。将使用交叉案例比较联合展示报告经过三角测量的定量和定性结果。
本研究方案已获得密歇根大学医学院机构审查委员会（IRBMED）的批准。研究结果将发表在同行评议的期刊上，在会议上展示，并分发给研究参与者。
