Westcombe A M, Gambles M A, Wilkinson S M, Barnes K, Fellowes D, Maher E J, Young T, Love S B, Lucey R A, Cubbin S, Ramirez A J
Marie Curie Palliative Care Research and Development Unit, Department of Psychiatry & Behavioural Sciences, Royal Free & University College Medical School, Hampstead, London, UK.
Palliat Med. 2003 Jun;17(4):300-7. doi: 10.1191/0269216303pm769rr.
Aromatherapy massage is used in cancer palliative care to improve quality of life but there is little evidence for its effectiveness. A large pragmatic multicentre randomized controlled trial was set up to examine the effectiveness of aromatherapy in improving psychological distress and quality of life in patients with cancer. This paper examines the challenges encountered in the design and execution of the study. The original design, i) focused on palliative care patients with advanced disease; ii) had both a no-intervention and a treatment control group (relaxation therapy); and iii) adopted 90% power for sample size calculations. A varied measurement strategy was employed. Recruitment proved difficult, referrers were 'gate-keeping', patients were often too ill to approach and others declined. The trial was modified to ensure viability. Eligibility was extended to all patients with cancer irrespective of stage, the relaxation group was removed and the power reduced to 80%. Although it is not generally good practice to change a study design once recruitment has started, the changes were consistent with the original basic study aims and design principles. The data collection phase was successfully completed in July 2002.
芳香疗法按摩被用于癌症姑息治疗以提高生活质量，但几乎没有证据表明其有效性。一项大型实用多中心随机对照试验被设立，以检验芳香疗法在改善癌症患者心理困扰和生活质量方面的有效性。本文探讨了该研究在设计和实施过程中遇到的挑战。最初的设计，i）聚焦于晚期疾病的姑息治疗患者；ii）设有无干预组和治疗对照组（放松疗法）；iii）样本量计算采用90%的检验效能。采用了多种测量策略。招募工作困难重重，转诊者起到了“把关”作用，患者往往病情过重无法参与，还有些人拒绝了。该试验进行了修改以确保可行性。资格标准扩大到所有癌症患者，不论疾病阶段，取消了放松组，并将检验效能降至80%。尽管在招募开始后改变研究设计通常不是好做法，但这些改变与最初的基本研究目标和设计原则是一致的。数据收集阶段于2002年7月成功完成。
