Patients' decision-making process regarding participation in phase I oncology research
Patients' decision-making process regarding participation in phase I oncology research
复制标题
DOI：
10.1200/jco.2006.06.0269
复制
发表时间：
2006-09-20
影响因子：
45.3
通讯作者：
Emanuel, Ezekiel J.
中科院分区：
文献类型：
--
作者：
Agrawal, Manish;Grady, Christine;Emanuel, Ezekiel J.
目的：本研究评估入选I期肿瘤研究的患者的决策过程。患者和方法：如果参与者同意参加5个癌症中心之一的I期癌症研究，懂英语，年龄大于18岁，则符合条件。训练有素的面试官进行结构化的面对面面试。结果在163名参与者中，88%是白人，96%有医疗保险，51%是大学毕业生或研究生。总体而言，81%的人知道临终关怀，但只有6%的人认真考虑过自己的临终关怀；84%的人知道姑息治疗，10%的人认真考虑过自己的姑息治疗；7%的人考虑不接受任何治疗。总的来说，75%的人报告了参加I期研究的中等或很大的压力，因为他们的癌症正在增长，而7%的人报告了来自研究人员的压力，9%的人感到来自他们家庭的压力。对于63%的患者来说，最重要的决策信息是I期药物杀死癌细胞；只有12%的人报告说药物的不良反应是最有用的信息。超过90%的患者表示，即使实验药物造成了严重的不良反应，包括10%的死亡机会，他们仍然会参加研究。结论患者知道有许多I期研究的替代方案，但没有认真考虑。很少有人受到来自家庭或研究人员的压力而参与研究。他们的主要目标是对抗癌症，几乎没有任何副作用，包括死亡，会阻止他们报名参加。
PurposeThis study assesses the decision-making process of patients enrolling in phase I oncology studies.Patients and MethodsParticipants were eligible if they had consented to participate in a phase I cancer study at one of five cancer centers, understood English, and were older than 18 years. Trained interviewers conducted structured in-person interviews.ResultsOf the 163 participants, 88% were white, 96% had health insurance, and 51% were college graduates or post graduates. Overall, 81% were aware of hospice, but only 6% had seriously considered hospice for themselves; 84% were aware of palliative care and 10% seriously considered it for themselves; and 7% considered getting no treatment at all. Overall, 75% reported moderate or a lot of pressure to participate in the phase I study because their cancer was growing, whereas 7% reported such pressure from the study investigators and 9% felt such pressure from their families. For 63% of patients, the most important information for decision making was that the phase I drug killed cancer cells; only 12% reported that the adverse effects of the drug(s) was the most useful information. More than 90% of patients said they would still participate in the study even if the experimental drug caused serious adverse effects, including a 10% chance of dying.ConclusionPatients are aware of many alternatives to phase I studies, but do not seriously consider them. Very few experience pressure from family or researchers to participate in research. Their main goal is to fight their cancer, and almost no adverse effect, including death, would dissuade them from enrolling.