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ENABLE II randomised controlled trial
Nurse-led multicomponent psychoeducational palliative intervention improves quality of life and mood in patients with advanced cancer
  1. Carole Willard
  1. Carole Willard
    University of Manchester, Room 6.328, Jean McFarlane Building, University Place, Oxford Road, Manchester M13 9PL, UK; carole.willard{at}

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Although there is a wealth of research highlighting the complex needs of patients with advanced cancer, robust research investigating the effectiveness of interventions remains sparse.1 The study by Bakitas and colleagues is unusual in two respects: first, randomised controlled trials are uncommon in palliative care because of problems with recruitment, ethical considerations and rigorously demonstrating cause and effect.2 Second, the study uses a telephone-based intervention described as a structured educational approach to encourage patient selfmanagement and empowerment.

The sample size is appropriate, and the selected end points of the study are central to the aims of palliative care—namely, quality of life, symptom intensity, resource use (days in hospital; intensive care unit and emergency department visits) and mood.

Patients are randomly allocated to the intervention or control group but, because of the nature of the intervention, are informed of their allocation; it is possible, therefore, that knowing about their allocation influences participants’ behaviour, although this is not acknowledged by the authors as a potential limitation. The intervention is administered by trained advanced practice nurses with palliative care expertise over an appropriate time period. The end points are measured with relevant, established tools and chart review.

The results suggest that the intervention is effective in improving quality of life and mood scores but has no impact on symptom intensity and use of resources. In fact, closer reading indicates that because actual recruitment falls short of the original recruitment targets, the difference in improvement between groups does not reach statistical significance. Nevertheless, as the authors point out, results can be clinically meaningful even if they do not achieve statistical significance.

The results should be considered with caution. Bakitas and colleagues note the lack of racial and ethnic diversity in the groups, which limits the ability to generalise the findings. Although the authors offer a reasonably comprehensive account of the intervention and cite a reference where more details can be found, there is very little information about the normal care received by the control group. This is particularly important for readers interested in implementing an intervention of this nature owing to the tremendous variation in the services available to palliative care clients and their carers in different localities. In addition, the intervention is based on a chronic care model that emphasises education, problem solving, self-management and crisis prevention and therefore bears some resemblance to the Expert Patient Programme3 in the UK. Although cancer is now considered a chronic condition for many, the patients recruited to this study had advanced, progressive disease with an estimated life expectancy of a year; therefore the extent to which the intervention is appropriate for this client group is unclear. In this respect it would be interesting and helpful to know why some participants decided to withdraw from the study. Interested readers should also be aware that an intense period of training was required for those involved in administering the intervention prior to its implementation and that the intervention itself appears quite resource intensive.

The resources required to implement the intervention, questions about its appropriateness in the context of advanced cancer and clinically, but not statistically, significant results in only two outcomes suggest that the intervention has limited usefulness when patients have a short life expectancy. Demonstrating which interventions are most appropriate, effective and cost-effective continues to be challenging in palliative care1 and particularly when patients are approaching the end of life. More creative but robust approaches to research will be needed if these challenges are to be overcome.

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  • Competing interests None.

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