The Deliverability, Acceptability, and Perceived Effect of the Macmillan Approach to Weight Loss and Eating Difficulties: A Phase II, Cluster-Randomized, Exploratory Trial of a Psychosocial Intervention for Weight- and Eating-Related Distress in People with Advanced Cancer.

CONTEXT: Up to 80% of people with cancer will develop weight loss and anorexia during the advanced stages of the disease. The Macmillan Weight and Eating Studies (2000-2009) have used the Medical Research Council complex interventions framework to develop the first psychosocial intervention for weight- and eating-related distress (WRD and ERD) in people with advanced cancer and their carers: The Macmillan Approach to Weight and Eating (MAWE). OBJECTIVES: This article reports the findings of a Phase II trial of MAWE that investigated its deliverability, acceptability, and patient-perceived effect on WRD and ERD. METHODS: The Phase II trial, conducted in 2006-2007, was of cluster-randomized design, with two community palliative care teams randomized to different arms. It used mixed methods to compare an intervention group (n=25), the MAWE group, which was supported by MAWE-trained clinical nurse specialists, with a group that received usual care (n=25), the control group. RESULTS: MAWE was deliverable in clinical practice and acceptable to patients. Unplanned exposure of the MAWE group to the intervention before an initial measure of WRD and ERD proved problematic to the trial process. Despite this, quantitative and qualitative analyses indicate that MAWE does not exacerbate WRD and ERD and may help patients with advanced cancer live with the weight loss and anorexia that are the symptoms of cancer cachexia syndrome. CONCLUSION: A follow-on randomized controlled trial of MAWE is warranted but should be of a revised design. [ABSTRACT FROM AUTHOR]