Malignant mesothelioma - can we improve quality of life?

Not Applicable

Completed

• Conditions: Mesothelioma; Cancer; Mesothelioma, unspecified

• Registration Number: ISRCTN18955704
• Lead Sponsor: Portsmouth Hospitals NHS Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25238873 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30661019 (added 09/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-31
• Study Completion: 2017-03-31
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 174

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified