PATIENT DECISION MARKING--PHASE 1 CLINICAL TRIALS

I期试验是新药临床开发的第一步 癌症疗法。I期研究的受试者通常是患者。 对他们来说，没有已知益处的标准疗法；这引发了 重大的伦理问题，因为大多数患者都接受了 亚治疗剂量，患者受益的潜力很小， 参与的患者群体特别容易受到伤害。在……里面 此外，可能存在潜在的利益冲突，因为医生和 护士护理员也可以是第一阶段研究团队的成员。这些 问题可能会影响患者充分参与的能力 决策过程，导致选择阶段的患者 我的试验更多是出于实现研究目标的需要，而不是 而不是什么对病人最好，并导致培养一种 患者、医生和护士之间的差距 参与的潜在风险和好处。更好的理解 在这种情况下的患者决策可以导致改善 方法支持患者、研究护士和 参与I期临床研究的医生。总目标 这个多学科、跨机构的财团将进行 一项确定患者体重的描述性横断面研究 影响分阶段参与决策的因素 我进行了临床试验。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 影响医生和护士对 患者参与I期治疗的益处和不良反应 临床试验；3)确定以下决定的影响 参与(或不参与)第一阶段临床试验 患者的生活质量，并评估做出的决定的满意度； 以及4)测试由 研究人员，HSRA模型(健康股票风险调整模型) 考虑参与I期试验的患者。500多名患者 接受I期临床治疗的晚期癌症患者 将为这项研究招募试验。基线和30个月的随访- Up病人访谈，以及对研究护士和医生的调查 每一位患者都将接受体检。这项多学科的研究 包括内科肿瘤学、护理、卫生服务领域的调查人员 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.