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

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.

Influence of delay on survival in patients with breast cancer: a systematic review.

BACKGROUND: Most patients with breast cancer are detected after symptoms occur rather than through screening. The impact on survival of delays between the onset of symptoms and the start of treatment is controversial and cannot be studied in randomised controlled trials. We did a systematic review of observational studies (worldwide) of duration of symptoms and survival. METHODS: We identified 87 studies (101,954 patients) with direct data linking delay (including delay by patients) and survival. We classified studies for analysis by type of data in the original reports: category I studies had actual 5-year survival data (38 studies, 53,912 patients); category II used actuarial or multivariate analyses (21 studies, 25,102 patients); and category III was all other types of data (28 studies, 22,940 patients). We tested the main hypothesis that longer delays would be associated with lower survival, and a secondary hypothesis that longer delays were associated with more advanced stage, which would account for lower survival. FINDINGS: In category I studies, patients with delays of 3 months or more had 12% lower 5-year survival than those with shorter delays (odds ratio for death 1.47 [95% CI 1.42-1.53]) and those with delays of 3-6 months had 7% lower survival than those with shorter delays (1.24 [1.17-1.30]). In category II, 13 of 14 studies with unrestricted samples showed a significant adverse relation between longer delays and survival, whereas four of five studies of only patients with operable disease showed no significant relation. In category III, all three studies with unrestricted samples supported the primary hypothesis. The 13 informative studies showed that longer delays were associated with more advanced stage. In studies that controlled for stage, longer delay was not associated with shorter survival when the effect of stage on survival was taken into account. INTERPRETATION: Delays of 3-6 months are associated with lower survival. These effects cannot be accounted for by lead-time bias. Efforts should be made to keep delays by patients and providers to a minimum.

Factors predicting delayed presentation of symptomatic breast cancer: a systematic review.

BACKGROUND: Delayed presentation of symptomatic breast cancer is associated with lower survival. Understanding of the factors that influence delay is important for the development of strategies to shorten delays. We did a systematic review to assess the quality and strength of evidence on risk factors for delays by patients and providers. METHODS: We generated hypotheses about the relation between each putative risk factor and delay, against which we tested studies. We did searches to identify papers containing original data related to risk factors for delays by patients (n=86) and providers (n=28). We critically appraised the papers for inclusion in the review according to predefined criteria. The small number of studies of adequate quality did not allow formal meta-analysis. We therefore assigned strength of evidence according to a combination of the number and size of studies supporting, not supporting, or refuting the hypotheses. FINDINGS: Most studies were deemed to be of poor quality and were excluded. Among 23 studies of adequate quality, however, there was strong evidence for an association between older age and delay by patients, and strong evidence that marital status was unrelated to delays by patients. Younger age and presentation with a breast symptom other than a lump were strong risk factors for delays by providers. Moderate evidence was shown for several other factors. INTERPRETATION: The strength of the current evidence is inadequate to inform the development of specific strategies to shorten delays by patients or providers. Clarification of the findings of this review through a major programme of primary research is urgently required.