Positive Health Online

Abstract

WESTCOMBE and colleagues, Marie Curie Palliative Care Research and Development Unit, Department of Psychiatry Behavioural Sciences, Royal Free University College Medical School, Hampstead, London, UK, have learned the hard way how to set up a clinical trial of aromatherapy massage for patients with terminal cancer. Abstract: Aromatherapy massage is used in palliative care in the belief that it improves quality of life. The authors planned to conduct a large multicentre randomized controlled clinical trial in order to investigate if this was true. The original study design focussed on terminally ill cancer patients, had two control groups (a no-intervention group, and a relaxation therapy group), and adopted 90% power for sample size calculation. However recruitment proved difficult when only terminally ill patients were included and this was modified to include all cancer patients irrespective of stage. The relaxation group was removed, and the power reduced to 80%. Although it is not normally good practice to change a study design once patient recruitment has started, these changes were consistent with the original study aim and therefore admissible. Thus the data collection was completed in July 2002.

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References

Westcombe AM, Gambles MA, Wilkinson SM, Barnes K, Fellowes D, Maher EJ, Young T, Love SB, Lucey RA, Cubbin S, Ramirez AJ. Learning the hard way! Setting up an RCT or aromatherapy massage for patients with advanced cancer. Palliative Medicine 17 (4): 300-307, Jun 2003.