CompletedNot Applicable

Malignant Mesothelioma - Can we Improve Quality of Life

Australia, United Kingdom319 participantsStarted 2014-04-03

Plain-language summary

Patients with malignant pleural mesothelioma (MPM) frequently have significant physical symptoms, with up to 92% of patients complaining of three or more symptoms at presentation. Such symptom scores are similar to those reported in advanced non small cell lung cancer (NSCLC) and have been demonstrated to correlate with interference with activity and worse quality of life (QOL). Several studies have reported that baseline Quality of Life (QOL) is a significant prognostic factor for survival in NSCLC patients. In 2010, a non-blinded randomised controlled trial of 151 patients in the United States (US) demonstrated an improved QOL, fewer depressive symptoms and improved survival with early, regular specialist palliative care team (SPCT) involvement in addition to their routine care. The RESPECT-Meso study will examine the effect on quality of life following early Specialist Palliative Care (SPC) involvement for Regular Early Symptom Control Treatment (RESSCT) in addition to routine care in patients with newly diagnosed MPM in the United Kingdom (UK).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological or cytological confirmation of malignant pleural mesothelioma (MPM) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. (Asymptomatic patients score 0; symptomatic but ambulatory patients score 1) * The diagnosis of MPM received within the last 6 weeks * Ability to provide written informed consent in English and comply with trial procedures Exclusion Criteria: * 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)). * Significant morbidity which the lead physician (or MDT) feel will unduly confound or influence QOL. * Those patients the MDT judge require referral to the SPCT at the point of diagnosis. * Concurrent, or less than 3 months, since participation in another non-mesothelioma clinical trial that may affect QOL. * Participation in a concurrent mesothelioma trial, within 12 weeks after randomisation, that may affect QOL. * 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.) * Chemotherapy treatment for MPM initiated prior to consent. * A significant history of depression / anxiety / psychiatric illness requiring specialist hospital care within the la…

What they're measuring

EORTC C-30 Quality of Life

Timeframe: 12 weeks

Trial details

NCT IDNCT03068117

SponsorPortsmouth Hospitals NHS Trust

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-01