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

Our plain-English summary of 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, by S. Gunatilake, F.J. Brims, C. Fogg, et al (Trials, 2014).

The study

• Authors: S. Gunatilake, F.J. Brims, C. Fogg, I. Lawrie, N. Maskell, K. Forbes, N. Rahman, S. Morris, R. Ogollah, S. Gerry, M. Peake, L. Darlison, A.J. Chauhan
• Journal: Trials
• Published: 2014;15:367
• Type of article: Randomized trial
• Cited by: 15 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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 4 weekly 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.

In plain English

This article is a study protocol. It describes a planned trial and reports no results. The authors set out how they would test whether regular, early care from specialist palliative care teams, who focus on symptom control, improves quality of life for people newly diagnosed with malignant pleural mesothelioma. The design was a multicentre, non-blinded, randomised controlled trial. A total of 174 patients were to be allocated in equal numbers to one of two groups. One group would receive specialist symptom control care every four weeks. The other would receive standard care. The main measure was to be patients' health related quality of life at 12 weeks. Patients were eligible only if they were relatively fit, with a performance score of 0 to 1. The authors acknowledged that patients and the immediate research team could not be blinded to which care was given. They also noted that the care itself was tailored to each person and could not be tightly defined. The authors stated that the study would inform clinicians of a potentially novel way to care for patients with this disease.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Study protocol for a multicentre, non-blinded, randomised controlled, parallel group trial (no results reported)
• Who was studied: A planned 174 patients with a new diagnosis of malignant pleural mesothelioma
• Exposure: Not an asbestos exposure study. The intervention was regular early specialist symptom control (palliative) care every four weeks, compared with standard care. The primary outcome was patient health related quality of life at 12 weeks.
• The authors' conclusion: The authors stated that the study would inform clinicians of a potentially novel way to care for patients with this high symptom-burden disease.
• Limitations the authors state:
  • Because of the nature of the intervention, participants and the immediate research team could not be blinded to which care was given.
  • Only patients with a performance score of 0 to 1 were to be included, which the authors described as a difficult decision.
  • The specialist care was tailored to each patient, so it could not be tightly defined.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Quality of Life, Malignant Mesothelioma, Pleural Mesothelioma, Mesothelioma, Median Survival, Chemotherapy, Palliative Care, Lung Cancer.

Related studies

• Protocol of the Australasian Malignant Pleural Effusion-2 (AMPLE-2) trial: a multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters — M. Azzopardi, R. Thomas, et al. (2016)
• CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial — D.A. Fennell, E. Kirkpatrick, et al. (2018)
• The impact of individual quality of life assessment on psychosocial attention in patients with chest malignancies: a randomized study — M. Nicklasson, M.L. Elfström, et al. (2013)
• Symptom Burden and Unmet Needs in Malignant Pleural Mesothelioma: Exploratory Analyses From the RESPECT-Meso Study — S.N. Hoon, I. Lawrie, et al. (2021)
• Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial — M. Maio, A. Scherpereel, et al. (2017)
• A randomised assessment of the use of a quality of life questionnaire with or without intervention in patients attending a thoracic cancer clinic — K. Nimako, B. Ayite, et al. (2017)

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