Impact of quality of life on patient expectations regarding phase I clinical trials
Impact of quality of life on patient expectations regarding phase I clinical trials
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DOI：
10.1200/jco.2000.18.2.421
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发表时间：
2000-01-01
影响因子：
45.3
通讯作者：
Meropol, NJ
中科院分区：
文献类型：
--
作者：
Cheng, JD;Hitt, J;Meropol, NJ
目的：生活质量（QOL）越来越多地被认为是衡量癌症治疗结果的关键指标，但关于QOL对患者决策过程的影响却知之甚少。进行了一项试点研究，以（1）测量患者，医生和研究护士对实验和标准治疗的潜在益处和毒性的期望，（2）确定QOL与患者对治疗方案的看法之间的关系。30名参加I期临床试验的癌症患者、他们的医生和他们的研究护士接受了评估人口统计学的问卷调查，结果：与医生相比，患者高估了实验性治疗的潜在获益和毒性（平均预期获益59.8% v23.8%，P <0.01;平均预期毒性29.8% v16.0%，P <0.01）。与标准治疗相比，患者估计实验治疗的获益潜力更大（59.8% v36.8%，P <0.01），毒性潜力更小（29.8% v45.6%，P = 0.01）。简表-36总体健康感知与患者对实验性治疗潜在获益的感知相关（r = .48，P = .01）。结论：I期临床试验的参与者对实验性治疗的成功有很高的期望，并对潜在毒性有折扣，患者QOL可能影响对实验性治疗获益的期望，并最终影响治疗选择。了解QOL和患者期望之间的相互作用可能会指导改进策略的制定，以向考虑早期临床试验的患者提供适当的信息。(C)2000年，美国临床肿瘤学会。
Purpose: Quality of life (QOL) is increasingly recognized as ct critical cancer-treatment outcome measure, but little is known about the impact of QOL on the patient decision-making process. A pilot study was conducted in an effort to (1) measure the expectations of patients, physicians, and research nurses regarding the potential benefits and toxicities from experimental and standard therapies, and (2) determine the relationship of QOL to patient perceptions regarding treatment options.Methods: Thirty cancer patients enrolling in phase I clinical trials, their physicians, and their research nurses were administered questionnaires that assessed demographics, QOL, and treatment expectations.Results: Compared with their physicians, patients overestimated potential benefits and toxicities from experimental therapy (mean expected benefit, 59.8% v 23.8%, P < .01; mean expected toxicity, 29.8% v 16.0%, P < .01). Patients estimated a greater potential for benefit (59.8% v 36.8%, P < .01) and less potential for toxicity (29.8% v 45.6%, P = .01) for experimental therapy, compared with standard therapy. Short Form-36 general health perception correlated with patient perception of potential benefit from experimental therapy (r = .48, P = .01),Conclusion: Participants in phase I clinical trial have high expectations regarding the success of experimental therapy and discount potential toxicity, Patient QOL may affect the expectation of benefit from experimental therapy and, ultimately, treatment choice. Understanding the interactions between QOL and patient expectations may guide the development of improved strategies to present appropriate information to patients considering early-phase clinical trials. (C) 2000 by American Society of Clinical Oncology.