Malignant mesothelioma - can we improve quality of life?
| ISRCTN | ISRCTN18955704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18955704 |
| ClinicalTrials.gov (NCT) | NCT03068117 |
| Protocol serial number | RESPECT-Meso 6.0, 17/02/2015 |
| Sponsor | Portsmouth Hospitals NHS Trust (UK) |
| Funder | British Lung Foundation (UK) - Asbestos Project Grant Ref.: APG12-13 |
- Submission date
- 12/12/2013
- Registration date
- 31/01/2014
- Last edited
- 25/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Portsmouth Hospitals NHS Trust
Department of Respiratory Medicine
Queen Alexandra Hospital
Southwick Hill road
Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)23 9228 6000 |
|---|---|
| chief-investigator-ajc@respect-meso.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre randomised non-blinded parallel group controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentre non-blinded randomised controlled trial to assess the impact of Regular Early SPEcialist symptom Control Treatment on quality of life in malignant Mesothelioma - 'RESPECT-Meso' |
| Study acronym | RESPECT-Meso |
| Study objectives | Can early referral to specialist palliative care services in newly diagnosed mesothelioma patients result in improved quality of life for patients and their caregivers? |
| Ethics approval(s) | NRES Committee London - Hampstead , 26/01/2012, ref: 12/LO/0078 |
| Health condition(s) or problem(s) studied | Mesothelioma |
| Intervention | 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 team (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. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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: |
| Completion date | 31/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 174 |
| Total final enrolment | 174 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 03/03/2014 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
- Australia
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Australia
United Kingdom
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | 09/08/2019 | Yes | No |
| Protocol article | protocol | 19/09/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/03/2020: Cancer Research UK lay results summary link added to Results (plain English).
09/08/2019: The following changes were made to the trial record:
1. ClinicalTrials.gov number added.
2. The trial website (www.respect-meso.org) is no longer active.
3. Publication reference added.
4. The total final enrolment was added.
22/11/2018: Poster abstract added.
21/09/2015: The following changes were made to the trial record:
1. The overall trial end date was changed from 11/01/2017 to 31/03/2017.
2. Australia was added to the countries of recruitment.
