A feasibility study: a mixed methods exploratory phase II cluster randomised trail to investigate the effectiveness of the 'Macmillan Approach to Weight loss and Eating difficulties'(MAWE)

Hopkinson, Jane B., Fenlon, Debbie, Foster, Claire, Nicholls, Peter, Wright, David N.M., Okamoto, Ikumi, Scott, Issy and Addington-Hall, Julia (2009) A feasibility study: a mixed methods exploratory phase II cluster randomised trail to investigate the effectiveness of the 'Macmillan Approach to Weight loss and Eating difficulties'(MAWE). NCRI Cancer Conference, Birmingham, United Kingdom. 04 - 07 Oct 2009.

Abstract

Background: this study is part of a programme of work using the MRC complex interventions framework to develop and test a psychosocial intervention for weight and eating related distress in people with cancer cachexia syndrome.

Aim: to establish the feasibility of conducting a cluster randomised controlled trial to evaluate the effectiveness of the Macmillan Approach to Weight and Eating (MAWE) by testing i) recruitment and data collection process, ii) the deliverability and acceptability of MAWE, and iii) the efficacy of MAWE.

Method: two specialist community palliative care teams in the South of England, 2006/07 were randomised to offer MAWE, or to deliver care as usual. Twenty-five patients supported by MAWE were compared with 25 patient controls. All participants were new referrals and concerned about weight loss or eating problems.

Primary outcome measure: VAS scales of weight related distress and eating related distress were completed by patient and carer at two time points. Secondary outcome measures: At the same time points all participants were interviewed and patient participants completed the EORTC-QLQ-C15-PAL.

Results: fifteen of the 65 recruited patients dropped out of the study, most because of death or deteriorating condition (n=12). Selecting only patients receiving nurse-led management delayed achievement of the recruitment target. MAWE trained nurses were able to integrate the approach within their everyday practice. But enthusiastic adoption of MAWE led to contamination of the baseline data and difficulty interpreting the measures. Descriptive statistics are consistent with MAWE mitigating weight and eating related distress. Qualitative data indicate that MAWE can help with self-management of weight and eating related problems. MAWE could be refined to address issues relating to co-morbidities.

Conclusion: this feasibility study has provided important information that can be used to guide the design and methodology of a full cluster randomised controlled trial.

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Contributors

Author: Claire Foster

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