Improving decision-making in patients with resectable melanoma and pre-existing autoimmune disease considering immune checkpoint inhibition

项目摘要 共同决策是一个旨在帮助医疗保健提供者和他们的病人做出知情决策的过程。 健康决定。在此过程中，信息交换（患者将其健康问题告知医生 和偏好和卫生保健提供者告知患者治疗的选择），以及将 最终导致管理方面的决定得到澄清。关于癌症治疗，患者 通常伴有其他合并症，可导致治疗相关毒性增加或获益减少 因为其他疾病的竞争风险。这些担忧使决策既在情感上， 认知困难。其中一个困难的决定是是否使用免疫疗法作为辅助治疗- 具体而言，免疫检查点通道-在患有可切除的黑色素瘤和预先存在的自身免疫性 疾病由于免疫介导的组织损伤，检查点抑制剂可引起不良事件， 免疫相关不良事件。在患有癌症和预先存在的自身免疫性疾病的患者中， 检查点抑制是可能的，但与不良事件和突发的发生率增加相关。因此，在本发明中， 这种治疗需要谨慎监测。 最佳治疗决策需要仔细考虑危害和益处以及 复发这项拟议研究的总体目标是开发和测试个性化的共享决策- 为患有可切除的黑色素瘤和预先存在的自身免疫性疾病的患者制造工具， 提供者改善关于启动免疫检查点辅助治疗的决策 抑制剂的此类工具尚待开发。 这一职业发展奖将提供主要研究者的保护时间成为一个决定 他是一位科学家，对癌症和共病患者的共同决策感兴趣。具体 她的研究计划的目的是评估免疫检查点抑制剂在患者中的益处和风险。 可切除的黑色素瘤和既存自身免疫性疾病，考虑到分期、生存期、 毒性和突发事件; 2）为癌症RA患者开发多组分共享决策工具 考虑用免疫检查点抑制剂治疗;和3）评估将适合于 低识字率的人群，并将根据患者的个人特点。为了实现她的职业目标， 首席研究员组建了一个多学科专家小组，在感兴趣的领域， 提出一个全面的培训计划。

PROJECT ABSTRACT Shared decision-making is a process aimed at helping health care providers and their patients make informed health decisions. During this process, information is exchanged (patients inform doctors about their health issues and preferences and health care providers inform patients about options for treatment), and options that will ultimately lead to a decision regarding management are clarified. Regarding cancer treatment decisions, patients often have other comorbidities, which can result in increased treatment-related toxicity or decreased benefits because of competing risk of other diseases. These concerns make decision-making both emotionally and cognitively difficult. One such difficult decision is whether to use immunotherapy as adjuvant therapy— specifically, immune checkpoint inhibitors—in patients with resectable melanoma and pre-existing autoimmune disease. Checkpoint inhibitors can cause adverse events due to immune-mediated tissue damage, termed immune-related adverse events. In patients with cancer and pre-existing autoimmune disease, immune checkpoint inhibition is possible but is associated with an increase incidence of adverse events and flares. Thus, this treatment requires cautious monitoring. Optimal treatment decisions require careful consideration of harms and benefits as well as the likelihood of recurrence. The overall goal of this proposed study is to develop and test an individualized shared decision- making tool for patients with resectable melanoma and pre-existing autoimmune disease that can be used with providers to improve the decision-making regarding initiation of adjuvant treatment with immune checkpoint inhibitors. Such tools have yet to be developed. This career development award will provide the principal investigator with protected time to become a decision scientist with an interest in shared decision-making by patients with cancer and comorbid conditions. The specific aims of her research proposal are to evaluate the benefits and risks of immune checkpoint inhibitors in patients with resectable melanoma and pre-existing autoimmune disease considering stage, survival, expected rates of toxicity, and flares; 2) to develop a multicomponent shared decision-making tool for cancer patients with RA considering treatment with immune checkpoint inhibitors; and 3) evaluate the tool which will be appropriate for low-literacy populations, and will be tailored to patients' individual characteristics. To achieve her career goals, the principal investigator has assembled a multidisciplinary team of experts in the fields of interest and is proposing a comprehensive training program.