Zaric Bojan, Perin Branislav, Ilic Aleksandra, Kopitovic Ivan, Matijasevic Jovan, Andrijevic Ljiljana, Secen Nevena, Stanic Jelena, Bijelovic Milorad, Kosjerina Zdravko, Antonic Milan
Institute for Pulmonary Diseases of Vojvodina, Clinic for Pulmonary Oncology, Faculty of Medicine, University of Novi Sad, Serbia.
Multidiscip Respir Med. 2011 Feb 28;6(1):20-7. doi: 10.1186/2049-6958-6-1-20.
The major aim of this study was to investigate what patients with advanced stage lung cancer, enrolled in a clinical trial, thought about their treatment. We also wanted to investigate if there exist any characteristics that could influence patients' opinion about the clinical trial.
Over the period from June 2008 to June 2009, 59 eligible patients were enrolled in this study. The major inclusion criteria were: participation in a clinical trial, previously treated advanced stage lung cancer, and good performance status (ECOG 0-2). All patients were asked to answer a questionnaire designed to investigate their impressions about participation in a clinical trial. The questionnaire was deposited in a sealed box which was opened at the end of the study.We investigated a possible influence of age, gender, education, lung cancer stage, chemotherapy line and tumor type on the patients' opinion about some aspects of the clinical trial.
The majority of the patients were aware they were participating in the clinical trial and a significant number of them were very satisfied with the treatment. Of the investigated factors, only the level of education had a statistically significant influence on some of the questions raised in the questionnaire.
Patients participating in clinical trials are satisfied with their treatment, ready to proceed with it and would recommend it to other patients. It depends mainly on health professionals to maintain this level of confidence and justify their trust.
本研究的主要目的是调查参加临床试验的晚期肺癌患者对其治疗的看法。我们还想研究是否存在任何可能影响患者对临床试验看法的特征。
在2008年6月至2009年6月期间，59名符合条件的患者参加了本研究。主要纳入标准为：参加临床试验、先前接受过治疗的晚期肺癌以及良好的体能状态（东部肿瘤协作组0 - 2级）。所有患者均被要求回答一份旨在调查他们对参加临床试验印象的问卷。问卷存放在一个密封的盒子里，在研究结束时打开。我们研究了年龄、性别、教育程度、肺癌分期、化疗疗程和肿瘤类型对患者对临床试验某些方面看法的可能影响。
大多数患者意识到他们正在参加临床试验，并且其中相当一部分对治疗非常满意。在所调查的因素中，只有教育程度对问卷中提出的一些问题有统计学上的显著影响。
参加临床试验的患者对其治疗感到满意，愿意继续接受治疗并会向其他患者推荐。主要取决于医疗专业人员维持这种信心水平并证明他们的信任是合理的。
