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

项目摘要 共享决策是一个旨在帮助医疗保健提供者和他们的患者了解情况的过程 健康决策。在这个过程中，信息被交换(患者向医生告知他们的健康问题 以及偏好和医疗保健提供者告知患者关于治疗的选择)，以及将 最终导致关于管理的决定被澄清。关于癌症治疗决定，患者 通常有其他合并症，这可能导致与治疗相关的毒性增加或益处减少 因为其他疾病的竞争风险。这些担忧使决策既有情绪上的，也有 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- 具体地说，免疫检查点抑制剂-在可切除的黑色素瘤和既往存在自身免疫的患者中 疾病。检查点抑制剂可由于免疫介导的组织损伤而导致不良事件，称为 与免疫相关的不良事件。在癌症和既有自身免疫性疾病的患者中，免疫 检查点抑制是可能的，但与不良事件和耀斑的发生率增加有关。因此， 这种治疗需要谨慎的监测。 最佳的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- 为可切除的黑色素瘤和既有自身免疫性疾病的患者制作工具，可用于 提供者通过免疫检查点改善关于启动辅助治疗的决策 抑制剂。这样的工具还有待开发。 这一职业发展奖将为首席调查员提供有保障的时间来做出决定 科学家，对癌症患者和其他疾病患者的共同决策感兴趣。具体的 她的研究提案的目的是评估免疫检查点抑制剂在患者中的益处和风险 对于可切除的黑色素瘤和既往存在的自身免疫性疾病，考虑分期、生存期、预期比率 毒性和耀斑；2)为RA癌症患者开发多组分共享决策工具 考虑使用免疫检查点抑制剂进行治疗；以及3)评估适用于 低识字率人群，并将根据患者的个体特征量身定做。为了实现她的职业目标， 首席调查员组建了一个由感兴趣领域的多学科专家组成的小组， 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.