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      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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          Abstract

          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.

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          Most cited references 37

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

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            Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma.

            Patients with malignant pleural mesothelioma, a rapidly progressing malignancy with a median survival time of 6 to 9 months, have previously responded poorly to chemotherapy. We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone. Chemotherapy-naive patients who were not eligible for curative surgery were randomly assigned to receive pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1, or cisplatin 75 mg/m2 on day 1. Both regimens were given intravenously every 21 days. A total of 456 patients were assigned: 226 received pemetrexed and cisplatin, 222 received cisplatin alone, and eight never received therapy. Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm (P =.020, two-sided log-rank test). The hazard ratio for death of patients in the pemetrexed/cisplatin arm versus those in the control arm was 0.77. Median time to progression was significantly longer in the pemetrexed/cisplatin arm: 5.7 months versus 3.9 months (P =.001). Response rates were 41.3% in the pemetrexed/cisplatin arm versus 16.7% in the control arm (P <.0001). After 117 patients had enrolled, folic acid and vitamin B12 were added to reduce toxicity, resulting in a significant reduction in toxicities in the pemetrexed/cisplatin arm. Treatment with pemetrexed plus cisplatin and vitamin supplementation resulted in superior survival time, time to progression, and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma. Addition of folic acid and vitamin B12 significantly reduced toxicity without adversely affecting survival time.
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              Early palliative care for patients with metastatic non-small-cell lung cancer.

              Patients with metastatic non-small-cell lung cancer have a substantial symptom burden and may receive aggressive care at the end of life. We examined the effect of introducing palliative care early after diagnosis on patient-reported outcomes and end-of-life care among ambulatory patients with newly diagnosed disease. We randomly assigned patients with newly diagnosed metastatic non-small-cell lung cancer to receive either early palliative care integrated with standard oncologic care or standard oncologic care alone. Quality of life and mood were assessed at baseline and at 12 weeks with the use of the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale and the Hospital Anxiety and Depression Scale, respectively. The primary outcome was the change in the quality of life at 12 weeks. Data on end-of-life care were collected from electronic medical records. Of the 151 patients who underwent randomization, 27 died by 12 weeks and 107 (86% of the remaining patients) completed assessments. Patients assigned to early palliative care had a better quality of life than did patients assigned to standard care (mean score on the FACT-L scale [in which scores range from 0 to 136, with higher scores indicating better quality of life], 98.0 vs. 91.5; P=0.03). In addition, fewer patients in the palliative care group than in the standard care group had depressive symptoms (16% vs. 38%, P=0.01). Despite the fact that fewer patients in the early palliative care group than in the standard care group received aggressive end-of-life care (33% vs. 54%, P=0.05), median survival was longer among patients receiving early palliative care (11.6 months vs. 8.9 months, P=0.02). Among patients with metastatic non-small-cell lung cancer, early palliative care led to significant improvements in both quality of life and mood. As compared with patients receiving standard care, patients receiving early palliative care had less aggressive care at the end of life but longer survival. (Funded by an American Society of Clinical Oncology Career Development Award and philanthropic gifts; ClinicalTrials.gov number, NCT01038271.)
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                Author and article information

                Contributors
                drsgunatilake@gmail.com
                chief-investigator-fjb@respect-meso.org
                carole.fogg@port.ac.uk
                iain.lawrie@pat.nhs.uk
                nick.maskell@bristol.ac.uk
                k.forbes@bristol.ac.uk
                naj_rahman@yahoo.co.uk
                steve.morris@ucl.ac.uk
                kogollah@gmail.com
                Stephen.gerry@csm.ox.ac.uk
                mick.peake@uhl-tr.nhs.uk
                liz.darlison@uhl-tr.nhs.uk
                chief-investigator-ajc@respect-meso.org
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                19 September 2014
                19 September 2014
                2014
                : 15
                : 1
                Affiliations
                [ ]RESPECT Meso trial co-ordinator, Portsmouth Hospitals NHS Trust, Portsmouth, England
                [ ]Consultant Respiratory Physician and Clinical Senior Lecturer, Sir Charles Gairdner Hospital, Perth, Western Australia Australia
                [ ]Senior Lecturer, University of Portsmouth/Portsmouth Hospitals NHS Trust, Portsmouth, England
                [ ]Consultant& Honorary Clinical Senior Lecturer in Palliative Medicine, The Pennine Acute Hospitals NHS Trust/The University of Manchester, Manchester, England
                [ ]Consultant and Reader, North Bristol Lung Centre, Southmead Hospital, Bristol, England
                [ ]Consultant and Macmillan Professorial Teaching Fellow, Bristol Haematology and Oncology Centre, Bristol, England
                [ ]Consultant and Senior Lecturer, Oxford Centre for Respiratory Medicine, Director Oxford Respiratory Trials Unit Churchill Hospital, Bristol, England
                [ ]Healthcare Economics, University College London, London, England
                [ ]Lecturer, University of Portsmouth, Portsmouth, England
                [ ]Trial statistician, Centre for Statistics in Medicine, University of Oxford, Oxford, England
                [ ]Consultant Physician & Senior Lecturer, Department of Respiratory Medicine, Glenfield Hospital, Leicester, England
                [ ]Nurse Consultant, Mesothelioma UK, Glenfield Hospital, Leicester, England
                [ ]Consultant Respiratory Physician and Director of Research & Development, Portsmouth Hospitals NHS Trust, Portsmouth, England
                Article
                2238
                10.1186/1745-6215-15-367
                4180732
                25238873
                8f280ce1-e4b6-4575-9211-6185d321003a
                © Gunatilake et al.; licensee BioMed Central Ltd. 2014

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2014

                Medicine

                mesothelioma, palliative care, symptom control, quality of life

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