Mesothelioma Cancer Mesothelioma, unspecified
Conditions
Interventions
Regular early Specialist Symptom Control Treatment (SSCT) and Standard Therapy.
In the regular early SSCT group, patients will be seen within three weeks of randomisation by the SPC
Sponsors
Portsmouth Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological or cytological confirmation of malignant pleural mesothelioma (MPM) 2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. (Asymptomatic patients score 0; symptomatic but ambulatory patients score 1) 3. The diagnosis of MPM received within the last 6 weeks 4. Ability to provide written informed consent in English and comply with trial procedures 5. Males and females aged 18 and over
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/09/2015: 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. Previous 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 quality of life (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 clinical trial that may affect QOL. 5. 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) 6. Chemotherapy treatment for MPM initiated prior to consent. 7. A significant history of depression / anxiety / psychiatric illness requiring specialist hospital care within the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this randomised controlled study is to assess the impact of regular early specialist symptom control treatment (SSCT) involvement on global quality of life (QOL) in patients recently diagnosed with malignant pleural mesothelioma (MPM) 12 weeks post randomisation as compared to standard care. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to assess the impact of regular early SSCT involvement in the care of patients recently diagnosed with MPM on the following: 1. QOL in patients after 24 weeks 2. Patient mood at 12 and 24 weeks 3. Primary caregiver QOL and mood at 12 and 24 weeks, and 24 weeks after patient death 4. Overall survival between the two study groups 5. Healthcare utilisation and healthcare costs 6. The cost-effectiveness of regular early SSCT when compared to usual practice Added 21/08/2014: 7. Sub-group analysis of HRQoL at 12 and 24 weeks for patients based on the neutrophil, lymphocyte ratio and radiological staging at time of diagnosis | — |
Countries
Australia, United Kingdom
Outcome results
None listed