PATIENT DECISION MARKING--PHASE 1 CLINICAL TRIALS

I期试验是新的临床开发的第一步。 癌症治疗 I期研究的受试者通常为患者 对于那些没有已知益处的标准治疗的人，这引起了 考虑到大多数患者接受治疗，存在重大伦理问题 如果剂量低于治疗剂量，患者获益的可能性很小， 参与的患者群体尤其脆弱。 在 此外，可能存在潜在的利益冲突，因为医生和 护理人员也可以是I期研究小组的成员。 这些 问题可能会损害患者充分参与 决策过程，导致选择患者进行阶段 I试验更多地是为了实现研究目标， 而不是什么是最好的病人，并导致培养一个 病人、医生和护士对病人的看法之间的差距 参与的潜在风险和益处。 一种更伟大理解 在这种情况下，患者的决策可能会导致改善 支持患者、研究护士决策的方法， 参与I期临床研究的医生。 总目标 这个多学科、跨机构的联合体将开展 一项描述性横断面研究，以确定患者的体重 影响参与阶段决策的因素 I临床试验。 该项目的具体目标是：（1）确定 影响患者决策的因素 参与I期临床试验; 2）确定 影响医生和护士的概率的看法 患者参与I期研究的获益和不良反应 临床试验; 3）确定决策的影响， 参与（或不参与）I期临床试验 患者生活质量，并评估对所做决定的满意度; 以及4）测试由 HSRA模型（Health Stock Risk Adjustment Model） 考虑参加I期试验的患者。超过500名患者 患有晚期癌症的患者， 本研究将招募试验。 基线和30个月随访- 对病人进行访谈，并对研究护士和医生进行调查， 每一位患者都将接受治疗。 这项多学科的研究 包括医学肿瘤学、护理、健康服务领域的研究者 研究、生物伦理学和心理学。

Phase I trials are the first step in the clinical development of new cancer therapies. Subjects for phase I studies are generally patients for whom there is no standard therapy of known benefit; this raises significant ethical concerns, given that most patients are treated with subtherapeutic doses, the potential for patient benefit is small and the participating patient population is particularly vulnerable. In addition, potential conflicts of interest may exist since physician and nurse caregivers can also be members of the phase I study team. These issues may compromise a patients ability to adequately participate in the decision making process, lead to the selection of patients for phase I trials driven more by the need to fulfill the goals of research rather than on what is best for the patient, and result in fostering a disparity between what patients, physicians and nurses perceive as the potential risks and benefits of participation. A greater understanding of patient decision making in this context could lead to improvement in methods to support the decision making of patients, research nurses, and physicians involved in phase I clinical investigation. The overall goal of this multidisciplinary, Inter-institutional consortium is to conduct a descriptive cross-sectional study to identify how patients weigh factors that affect decision making concerning participation in phase I clinical trials. The specific aims of this project are 1) to identify factors that influence decision making in patients considering participation in phase I clinical trials; 2) to identify factors that influence physicians and nurses perceptions of the probability of benefit and adverse reactions of patient participation in phase I clinical trials; 3) to determine the impact of decisions about participation (or non-participation) in phase I clinical trials on patient quality of life, and assess satisfaction with decisions made; and 4) to test a novel decision making model developed by the investigators, the HSRA model (Health Stock Risk Adjustment Model) in patients considering phase I trial participation. More than 500 patients with advanced cancer who are offered participation in phase I clinical trials will be recruited for this study. Baseline and 30 month follow- up patient interviews, and surveys of research nurses and physicians for each patient will be conducted. This multi-disciplinary research includes investigators in medical oncology, nursing, health services research, bioethics, and psychology.