Protocol for PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention.

INTRODUCTION: Histological diagnosis of malignant mesothelioma requires an invasive procedure such as CT-guided needle biopsy, thoracoscopy, video-assisted thorascopic surgery (VATs) or thoracotomy. These invasive procedures encourage tumour cell seeding at the intervention site and patients can develop tumour nodules within the chest wall. In an effort to prevent nodules developing, it has been widespread practice across Europe to irradiate intervention sites postprocedure--a practice known as prophylactic irradiation of tracts (PIT). To date there has not been a suitably powered randomised trial to determine whether PIT is effective at reducing the risk of chest wall nodule development. METHODS AND ANALYSIS: In this multicentre phase III randomised controlled superiority trial, 374 patients who can receive radiotherapy within 42 days of a chest wall intervention will be randomised to receive PIT or no PIT. Patients will be randomised on a 1:1 basis. Radiotherapy in the PIT arm will be 21 Gy in three fractions. Subsequent chemotherapy is given at the clinicians' discretion. A reduction in the incidence of chest wall nodules from 15% to 5% in favour of radiotherapy 6 months after randomisation would be clinically significant. All patients will be followed up for up to 2 years with monthly telephone contact and at least four outpatient visits in the first year. ETHICS AND DISSEMINATION: PIT was approved by NRES Committee North West-Greater Manchester West (REC reference 12/NW/0249) and recruitment is currently on-going, the last patient is expected to be randomised by the end of 2015. The analysis of the primary end point, incidence of chest wall nodules 6 months after randomisation, is expected to be published in 2016 in a peer reviewed journal and results will also be presented at scientific meetings and summary results published online. A follow-up analysis is expected to be published in 2018. TRIAL REGISTRATION NUMBER: ISRCTN04240319; NCT01604005; Pre-results.

Living with mesothelioma. A literature review.

Mesothelioma is an asbestos-related cancer that affects mainly the pleura. World-wide incidence is increasing and set to rise for some time particularly in developing countries. Mesothelioma is uniformly fatal and often associated with difficult symptoms. The purpose of this review is to identify what is known about the experience of people living with mesothelioma. A literature search identified 13 papers covering qualitative studies, patient-reported quality of life data collected as part of a clinical trial, symptoms and survey of patients and carers. The findings suggest the impact of mesothelioma is multidimensional on: physical symptoms (especially pain, breathlessness, fatigue, cough, sleep disturbance, appetite loss and sweating), emotional functioning (anxiety, depression, fear and isolation), social consequences (changes in roles and relationships) and interventions (the necessity of frequent anti-cancer treatments and admissions for symptom control). The impact on family members is significant also. Although limited, these findings provide an important insight into the impact of mesothelioma on patients and family members and suggest areas where service provision may fail to meet their needs. Finally, the review highlights an urgent need for further research to more fully understand the experience of living with mesothelioma and identify the specific needs of patients and family members.

A flexible approach yields multiple benefits. Assessment of the benefits of flexible shifts.

1. Analysis of workload pattern is fundamental to human resource management. 2. Patient centred care demands more static staffing levels. 3. Flexibility in working hours enhances staff retention. 4. Reduced pay costs mean ancillary staff can be employed to fulfil non-nursing duties.