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.

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.

The impact of individual quality of life assessment on psychosocial attention in patients with chest malignancies: a randomized study.

PURPOSE: The aims of this study were to investigate the impact of individual health-related quality of life (HRQL) evaluation on the attention towards symptom control and psychosocial function in advanced cancer patients. METHODS: Patients with advanced lung cancer or mesothelioma who attended a pulmonary oncology outpatient clinic were randomized to either of two strategies for HRQL assessment. The experimental group (EG) answered the EORTC QLQ-C30 + LC13 questionnaire using a digital table interface, with outprint of aggregated scale scores presented to the consulting physician as a support for evaluation. The control group (CG) answered a paper version of the same questionnaire, which was stored for later analysis. Consultations were audio-recorded. Outcome measures were a quantitative content analysis of audio-recorded consultations and medical and psychosocial interventions abstracted from clinical records. RESULTS: One hundred seventy-one patients were randomized and participated in the study. Issues regarding emotional function were more frequently discussed during consultations in the EG (p < 0.05). Similarly, interventions directed to emotional and social concerns were more frequent in the EG (p = 0.013 and p = 0.0036, respectively). HRQL measures over time were similar across the groups. CONCLUSION: Individual HRQL assessment increased the attention to psychosocial functioning in patients with chest malignancies.