Meropol Neal J, Weinfurt Kevin P, Burnett Caroline B, Balshem Andrew, Benson Al B, Castel Liana, Corbett Sandra, Diefenbach Michael, Gaskin Darrell, Li Yun, Manne Sharon, Marshall John, Rowland Julia H, Slater Elyse, Sulmasy Daniel P, Van Echo David, Washington Shakira, Schulman Kevin A
Division of Medical Science, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
J Clin Oncol. 2003 Jul 1;21(13):2589-96. doi: 10.1200/JCO.2003.10.072.
To describe and compare the perceptions of cancer patients and their physicians regarding phase I clinical trials.
Eligible patients had been offered phase I trial participation and had decided to participate but had not yet begun treatment. Each patient's physician also served as a study subject. Patients and physicians completed questionnaires with domains including perceptions of potential benefit and harm from treatment (experimental and standard), relative value of quality and length of life, and perceived content of patient-physician consultations.
Three hundred twenty-eight patients and 48 physicians completed surveys. Patients had high expectations regarding treatment outcomes (eg, median 60% benefit from experimental therapy), with those choosing to participate in a phase I trial being more optimistic than those declining phase I participation. Patients predicted a higher likelihood of both benefit and adverse reactions from treatment (experimental and standard) than their physicians (P <.0001 for all comparisons). Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with their physicians. In contrast, 73% of physicians reported that this topic was discussed (P <.0001).
Cancer patients offered phase I trial participation have expectations for treatment benefit that exceed those of their physicians. The discordant perceptions of patients and physicians may possibly be explained by patient optimism and confidence; however, the discrepancies in reports of consultation content, particularly given patients' stated values regarding quality of life, raise the possibility that communication in this context is suboptimal.
描述并比较癌症患者及其医生对I期临床试验的看法。
符合条件的患者已被邀请参与I期试验并决定参与，但尚未开始治疗。每位患者的医生也作为研究对象。患者和医生完成了问卷，问卷内容包括对治疗（试验性和标准性）潜在益处和危害的看法、生活质量和寿命的相对价值，以及患者与医生咨询的内容。
328名患者和48名医生完成了调查。患者对治疗结果期望很高（例如，试验性治疗的中位获益率为60%），选择参与I期试验的患者比拒绝参与I期试验的患者更乐观。患者预测治疗（试验性和标准性）带来益处和不良反应的可能性均高于医生（所有比较的P<.0001）。虽然95%的患者报告生活质量至少与寿命一样重要，但只有28%的患者报告与医生讨论了治疗后生活质量的变化。相比之下，73%的医生报告讨论了这个话题（P<.0001）。
被邀请参与I期试验的癌症患者对治疗益处的期望超过了他们的医生。患者和医生看法不一致可能是由于患者的乐观和自信；然而，咨询内容报告的差异，特别是考虑到患者对生活质量的既定价值观，增加了这种情况下沟通不理想的可能性。
