Wootten Addie C, Abbott Jo M, Siddons Heather M, Rosenthal Mark A, Costello Anthony J
Department of Urology, Royal Melbourne Hospital, Level 3 Centre, Main Building, Grattan St, Parkville, Melbourne, Victoria, 3050, Australia.
Support Care Cancer. 2011 Jan;19(1):49-55. doi: 10.1007/s00520-009-0787-z. Epub 2009 Dec 4.
This study aims to explore the experiences of patients enrolled in a cancer-related clinical drug treatment trial utilising a qualitative focus-group methodology. Specifically, this study aimed to explore the impact of social and family support, the challenges and advantages of taking part in a clinical trial and the experiences of patients at the conclusion of the trial.
A qualitative study was conducted at a public hospital in Melbourne in 2008. A total of 14 participants were recruited. Three focus groups and two interviews were conducted with 13 patients who had completed a cancer-related clinical trial. Comments from a letter written by a trial participant were also analysed. Interviews were audio-recorded, transcribed and coded according to emerging themes.
Information obtained was grouped around four main themes; making sense of trial participation, challenges of treatment in the context of clinical trial participation, support during trial participation and coping with trial conclusion. Participants experienced a mixture of hope, uncertainty and apprehension as they considered whether to take part in a clinical trial. At different stages of the trial they made sense of their participation by thinking about the possible benefits of participation. Trial participation was also associated with a number of emotional and practical challenges. Generally, participants were very positive about the support they received from health professionals, family and friends. The end of the trial was associated with a mix of emotions, including relief, disappointment, hope of future help, uncertainty and abandonment.
Clinical trial participation is a positive experience for many patients with cancer, although there are a number of associated practical and emotional challenges. Trial participants may benefit from closer follow-up from clinical trial staff, especially the treating doctor, assessment of support needs and help in re-evaluating the meaning of their trial participation if their initial hopes and expectations are not met.
本研究旨在运用定性焦点小组方法，探索参与癌症相关临床药物治疗试验的患者的经历。具体而言，本研究旨在探讨社会和家庭支持的影响、参与临床试验的挑战与优势以及试验结束时患者的经历。
2008年在墨尔本的一家公立医院进行了一项定性研究。共招募了14名参与者。对13名完成癌症相关临床试验的患者进行了三个焦点小组讨论和两次访谈。还分析了一名试验参与者写的一封信中的评论。访谈进行了录音、转录，并根据新出现的主题进行编码。
获得的信息围绕四个主要主题进行了分类；理解试验参与、临床试验参与背景下的治疗挑战、试验参与期间的支持以及应对试验结束。参与者在考虑是否参加临床试验时，经历了希望、不确定和担忧的混合情绪。在试验的不同阶段，他们通过思考参与可能带来的好处来理解自己的参与。试验参与还与一些情感和实际挑战相关。总体而言，参与者对从医护人员、家人和朋友那里得到的支持非常满意。试验结束伴随着多种情绪，包括解脱、失望、对未来帮助的希望、不确定和被抛弃感。
对于许多癌症患者来说，参与临床试验是一次积极的经历，尽管存在一些相关的实际和情感挑战。试验参与者可能会从临床试验工作人员，尤其是主治医生的密切随访、对支持需求的评估以及如果他们最初的希望和期望未得到满足时在重新评估其试验参与意义方面得到的帮助中受益。
