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

Abstract

BackgroundMalignant 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.MethodsThis 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.DiscussionCurrent 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 registrationCurrent controlled trials ISRCTN18955704.Date ISRCTN assigned: 31 January 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-367) contains supplementary material, which is available to authorized users.

Malignant pleural mesothelioma: an update on investigation, diagnosis and treatment

“…Given the lack of curative treatment and the limited life expectancy, the overriding aim with MPM is to maintain quality of life and allow patients to live a meaningful and dignified life [1]. A multicentre randomised controlled trial is currently underway evaluating whether early specialist palliative care involvement improves patient-reported quality of life in MPM [136].…”

Investigating the Effect of Aging and Time on the Fate and Transport of Lead in Artificially Contaminated Tropical Soils

“…Though there is no known safe level of Pb exposure, however, a substantially high blood Pb level can result in adverse health effects (U.S CDC Advisory Committee, 2012, Zahran, et al, 2013. The average concentration of Pb in surface soils worldwide is 32 ppm but varies from 10 ppm to 67 ppm (Pendias, et al, 2001;Wuana et al, 2011;Gunatilake, et al, 2014). Studies have shown that plants do not readily take up Pb from soils, however, in soils that have high Pb content, significant levels of Pb have been found in roots of plants growing in such soils (Wuana, et al, 2011;Alvarez-Ayuso, et al, 2012).…”

“…The worst affected group are children below six years of age, and common health effects associated with this group include; intellectual deficits, low birth weight, nervous system, red blood cell and kidney damage (Needleman et al, 2004, Oulhote et al, 2013Zahran, et al, 2013;Gunatilake et al, 2014). A typical example of the effect of Pb poisoning in children is the incident which occurred in June 2010, in Zamfara state, Northwestern Nigeria.…”

Mesothelioma in Australia: a review

“…Multidisciplinary palliative care is vital throughout the course of the disease; patients with MM and their families need the support of community care organisations for managing life at home for as long as possible. The results of a large international randomised study (including Australia) that examined the utility of early palliative care in patients with pleural MM should be published soon 30 …”

“…The results of a large international randomised study (including Australia) that examined the utility of early palliative care in patients with pleural MM should be published soon. 30…”