A study to learn more about treating malignant mesothelioma - can we improve quality of life?
RESPECT-meso study summary table:
Title:A multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist palliative care treatment on quality of life on malignant mesotheliomaShort Title / acronym:RESPECT – MesoSponsor name Portsmouth NHS Hospitals TrustFunder name & reference:British Lung Foundation APG12-13REC reference:London – Hampstead 12/LO/0078Overall aim:To compare the effects of specialist palliative care treatment soon after diagnosis in patients with malignant mesothelioma, with usual care.Design:A two-arm (non-blinded) RCTPrimary endpoint:Health related quality of life (HRQoL) for patients at 12 weeks Secondary endpoints: 24 week HRQoL for patients 12 and 24 week mood for patients 12 and 24 week HRQoL and mood for caregivers Overall survival Quality Adjusted Life Years measurement (QALY) Use of health care resources Need for end of life intervention and place of death Caregiver HRQoL and mood 24 weeks after patient deathTarget accrual:174 patients (and up to 174 carers)Inclusion criteria:Histologically or cytologically proven malignant pleural mesothelioma (MPM)ECOG PS of 0-1The diagnosis of MPM received within the last 6 weeks.Ability to provide written informed consent in English and comply with trial procedures. Permission of the lead physician and/or local cancer Multidisciplinary Team (MDT).Exclusion criteria:1.Other known malignancy within 5 years (excluding localised squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, grade III and low grade prostate cancer (Gleason score <5, with no metastases)).2.Significant morbidity which the lead physician (or MDT) feel will unduly confound or influence QOL.3.Those patients the MDT judge require referral to the SPCT at the point of diagnosis.4.Concurrent, or less than 3 months, since participation in another non-mesothelioma clinical trial that may affect QOL.5.Participation in a concurrent mesothelioma trial, within 12 weeks after randomisation, that may affect QOL.6.Referral at the time of recruitment for cytoreductive, tumour de-bulking, radical decortication or extrapleural pneumonectomy surgery for MPM. (Video Assisted Thoracoscopic Surgery or ‘mini’ thoracotomy for pleurodesis and diagnosis attempts are permissible.)7.Chemotherapy treatment for MPM initiated prior to consent.8.A significant history of depression / anxiety / psychiatric illness requiring specialist hospital care within the last 12 months.Planned number of sites: Four lead centres, with requirement for further expansion to at least tenDuration of recruitment:2 yearsDuration of follow up:Death / end of trialDefinition of end of trial:Last follow up (24 weeks after randomisation), last patient.