A multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma (RESPECT-MESO): study protocol for a randomised controlled trial

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• 作者：Samal Gunatilake ; Fraser JH Brims ; Carole Fogg ; Iain Lawrie ; Nick Maskell…
• 关键词：Mesothelioma ; Palliative care ; Symptom control ; Quality of life
• 刊名：Trials
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：15
• 期：1
• 全文大小：486 KB
• 参考文献：1. Rake, C, Gilham, C, Hatch, J, Darnton, A, Hodgson, J, Peto, J (2009) Occupational, domestic and environmental mesothelioma risks in the British population: a case-control study. Br J Cancer 100: pp. 1175-83 class="external" href="http://dx.doi.org/10.1038/sj.bjc.6604879" target="_blank" title="It opens in new window">CrossRef
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• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Malignant pleural mesothelioma is an incurable cancer caused by exposure to asbestos. The United Kingdom has the highest death rate from mesothelioma in the world and this figure is increasing. Median survival is 8 to 12?months, and most patients have symptoms at diagnosis. The fittest patients may be offered chemotherapy with palliative intent. For patients not fit for systemic anticancer treatment, best supportive care remains the mainstay of management. A study from the United States examining advanced lung cancer showed that early specialist palliative care input improved patient health related quality of life and depression symptoms 12?weeks after diagnosis. While mesothelioma and advanced lung cancer share many symptoms and have a poor prognosis, oncology and palliative care services in the United Kingdom, and many other countries, vary considerably compared to the United States. The aim of this trial is to assess whether regular early symptom control treatment provided by palliative care specialists can improve health related quality of life in patients newly diagnosed with mesothelioma. Methods This multicentre study is an non-blinded, randomised controlled, parallel group trial. A total of 174 patients with a new diagnosis of malignant pleural mesothelioma will be minimised with a random element in a 1:1 ratio to receive either 4weekly regular early specialist symptom control care, or standard care. The primary outcome is health related quality of life for patients at 12?weeks. Secondary outcomes include health related quality of life for patients at 24?weeks, carer health related quality of life at 12 and 24?weeks, patient and carer mood at 12 and 24?weeks, overall survival and analysis of healthcare utilisation and cost. Discussion Current practice in the United Kingdom is to involve specialist palliative care towards the final weeks or months of a life-limiting illness. This study aims to investigate whether early, regular specialist care input can result in significant health related quality of life gains for patients with mesothelioma and if this change in treatment model is cost-effective. The results will be widely applicable to many institutions and patients both in the United Kingdom and internationally. Trial registration Current controlled trials ISRCTN18955704. Date ISRCTN assigned: 31 January 2014.