PERCEPTIONS OF CANCER-PATIENTS AND THEIR PHYSICIANS INVOLVED IN PHASE-I TRIALS
PERCEPTIONS OF CANCER-PATIENTS AND THEIR PHYSICIANS INVOLVED IN PHASE-I TRIALS
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DOI：
10.1200/jco.1995.13.5.1062
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发表时间：
1995-05-01
影响因子：
45.3
通讯作者：
SIEGLER, M
中科院分区：
文献类型：
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作者：
DAUGHERTY, C;RATAIN, MJ;SIEGLER, M
目的：为了了解与癌症患者参与I期试验相关的一些复杂问题，以及患者对这些试验的看法，我们对30名知情同意参加我们机构I期试验的癌症患者进行了一项试点调查研究。同时，被调查的患者确定为负责其护理的肿瘤学家也进行了调查。患者和方法：30例连续患者中有27例同意并完成了调查。患者在接受任何研究药物之前进行了调查。18位肿瘤学家参与了这项调查研究。结果：85%的患者决定参加I期试验是因为可能的治疗益处，11%是因为医生的建议/信任，4%是因为家庭压力。93%的人说他们理解所有（33%）或大部分（60%）提供的关于他们决定参加的试验的信息。只有33%的患者能够陈述他们参与的试验的目的，而能够陈述I期试验目的的患者受到的教育更多（P = 0.01）。接受调查的肿瘤学家对参与I期试验的患者可能的益处和毒性的期望有广泛的看法。结论：参与I期试验的癌症患者强烈希望获得治疗益处。利他的感觉似乎在激励患者参与这些试验中起着有限和无关紧要的作用。参加I期试验的癌症患者似乎对研究药物的风险有足够的自我认知知识。然而，只有少数患者似乎对I期试验作为剂量递增/剂量确定研究的目的有足够的理解。
Purpose: In an attempt to understand some of the complex issues related to the participation of cancer patients in phase I trials, and the perceptions of patients toward these trials, we conducted a pilot survey study of 30 cancer patients who had given informed consent to participate in a phase I trial at our institution. Concurrently, the oncologists identified by the surveyed patients as responsible for their care were surveyed as well.Patients and Methods: Twenty-seven of 30 consecutive patients agreed to and completed the survey. Patients were surveyed before they received any investigational agents. Eighteen oncologists participated in this survey study.Results: Eighty-five percent of patients decided to participate in a phase I trial for reasons of possible therapeutic benefit, 11% because of advice/trust of physicians, and 4% because of family pressures. Ninety-three percent said that they understood all (33%) or most (60%) of the information provided about the trials in which they had decided to participate. Only 33% were able to state the purpose of the trial in which they were participating, with patients able to state the purpose of phase I trials being more educated (P = .01). Surveyed oncologists had wide-ranging beliefs regarding expectations of possible benefits and toxicities for their patients participating in phase I trials.Conclusion: Cancer patients who participate in phase I trials are strongly motivated by the hope of therapeutic benefit. Altruistic feelings appear to have a limited and inconsequential role in motivating patients to participate in these trials. Cancer patients who participate in phase I trials appear to have an adequate self-perceived knowledge of the risks of investigational agents. However, only a minority of patients appear to have an adequate understanding of the purpose of phase I trials as dose-escalation/dose-determination studies.