Palliat Med. 2003 Jun; 17(4): 300-7.

Learning the hard way! Setting up an RCT of aromatherapy massage for patients with advanced cancer.

Westcombe AM, Gambles MA, Wilkinson SM, Barnes K, Fellowes D, Maher EJ, Young T, Love SB, Lucey RA, Cubbin S, Ramirez AJ.

Marie Curie Palliative Care Research and Development Unit, Department of Psychiatry & Behavioural Sciences, Royal Free & University College Medical School, Hampstead, London, UK.

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.