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

被引：15

作者：

Gunatilake, Samal ^{[1
]}

Brims, Fraser J. H. ^{[2
]}

Fogg, Carole ^{[3
]}

Lawrie, Iain ^{[4
]}

Maskell, Nick ^{[5
]}

Forbes, Karen ^{[6
]}

Rahman, Najib ^{[7
]}

Morris, Steve ^{[8
]}

Ogollah, Reuben ^{[9
]}

Gerry, Stephen ^{[10
]}

Peake, Mick ^{[11
]}

Darlison, Liz ^{[12
]}

Chauhan, Anoop J. ^{[13
]}

机构：

[1] Portsmouth Hosp NHS Trust, Portsmouth, Hants, England

[2] Sir Charles Gairdner Hosp, Consultant Resp Phys & Clin Senior Lecturer, Perth, WA 6000, Australia

[3] Univ Portsmouth, Portsmouth Hosp NHS Trust, Portsmouth, Hants, England

[4] Univ Manchester, Pennine Acute Hosp NHS Trust, Consultant & Honorary Clin Senior Lecturer Pallia, Manchester, Lancs, England

[5] Southmead Hosp, North Bristol Lung Ctr, Bristol, Avon, England

[6] Bristol Haematol & Oncol Ctr, Consultant & Macmillan Professorial Teaching Fel, Bristol, Avon, England

[7] Director Oxford Resp Trials Unit Churchill Hosp, Oxford Ctr Resp Med, Bristol, Avon, England

[8] UCL, Healthcare Econ, London, England

[9] Univ Portsmouth, Portsmouth, Hants, England

[10] Univ Oxford, Ctr Stat Med, Oxford, England

[11] Glenfield Hosp, Dept Resp Med, Leicester, Leics, England

[12] Glenfield Hosp, Leicester, Leics, England

[13] Portsmouth Hosp NHS Trust, Director Res & Dev, Portsmouth, Hants, England

来源：

TRIALS | 2014年 / 15卷

关键词：

Mesothelioma; Palliative care; Symptom control; Quality of life; EARLY PALLIATIVE CARE; CANCER; POPULATION; MORTALITY;

D O I：

10.1186/1745-6215-15-367

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：8

共 26 条

[1] World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects [J].

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 310 (20) :2191-2194

[2] MESOTHELIOMA IN THE 21ST CENTURY. A 1-YEAR SURVEY OF MALIGNANT MESOTHELIOMA IN THE SOUTH WEST OF THE UK [J].

Bhatnagar, R. ;

Earl, S. ;

Lansdell, K. ;

Howell, T. J. .

THORAX, 2010, 65 :A106-A107

[3]

Briggs A, 1998, J Health Serv Res Policy, V3, P233

[4]

Brims F J H, 2009, J R Nav Med Serv, V95, P4

[5]

Brims FJH, 2013, CURR PULMONOL REP, V2, P100, DOI 10.1007/s13665-013-0045-1

[6] Outcomes and complications following medical thoracoscopy [J].

Brims, Fraser John Hall ;

Arif, Mohammad ;

Chauhan, Anoop Jivan .

CLINICAL RESPIRATORY JOURNAL, 2012, 6 (03) :144-149

[7]

British Infection Society, 2007, Thorax, V62 Suppl 1, P1

[8] Population based epidemiology and prognosis of mesothelioma in Leeds, UK [J].

Chapman, A. ;

Mulrennan, S. ;

Ladd, B. ;

Muers, M. F. .

THORAX, 2008, 63 (05) :435-439

[9]

DOH, 2010, NAT HLTH SERV REF CO

[10]

Fayers PM, 2001, EORTC QLQ C 30 SCORI

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