Malignant Mesothelioma - Can we Improve Quality of Life (RESPECT-Meso)
Mesothelioma, Malignant
About this trial
This is an interventional supportive care trial for Mesothelioma, Malignant focused on measuring Specialist Palliative Care, Symptom Control, Early Referral, Quality of Life, Malignant Pleural Mesothelioma, Mesothelioma
Eligibility Criteria
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 last 12 months.
Sites / Locations
- Sir Charles Gairdner Hospital
- County Durham and Darlington NHS Foundation Trust
- Basildon and Thurrock University Hospitals NHS Foundation Trust - Basildon Hospital
- Mid Essex Hospital Services NHS Trust - Broomfield Hospital
- Hampshire Hospitals NHS Foundation Trust
- Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
- University Hospital Southampton NHS Foundation Trust
- Norfolk & Norwich University Hospitals NHS Foundation Trust
- Sherwood Forest Hospitals NHS Foundation Trust
- Nottinghamshire Healthcare NHS Foundation Trust
- Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
- Ipswich Hospital NHS Trust
- Northumbria Healthcare NHS Foundation Trust
- Great Western Hospital NHS Foundation Trust
- North Bristol NHS Trust - Southmead Hospital
- University Hospital of South Manchester NHS Trust
- Pennine Acute Hospitals NHS Trust
- South Tyneside NHS Foundation Trust
- The Royal Wolverhampton NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
RESSCT plus Standard Care/Therapy
Standard Care/Therapy
Regular Early Specialist Symptom Control Treatment (RESSCT) and Standard Therapy. Participants will be seen within three weeks of randomisation by the Specialist Palliative Care Team (SPCT), (regardless of, and in addition to, all other treatments being offered). The initial meeting will be an approximately 1 hour consultation with a member of the Specialist Palliative Care team. This may be either a Consultant or Specialist Palliative Care Clinical Nurse Specialist (SPCCNS). Patients will then continue to be seen regularly on at least a 4 weekly basis (regardless of other treatments, interventions and symptoms) by a member of the SPCT, with consultations lasting approximately 30 minutes. These monthly reviews will continue until end of trial (EOT) or patient death.
The standard care/therapy control group will continue to receive all appropriate, standard treatment for Malignant Pleural Mesothelioma (MPM) currently available to them and will be initiated by the patient's General Practitioner (GP), the cancer MDT or lead respiratory physician as required.