Malignant mesothelioma - can we improve quality of life?
| ISRCTN | ISRCTN18955704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18955704 |
| ClinicalTrials.gov number | NCT03068117 |
| Secondary identifying numbers | RESPECT-Meso 6.0, 17/02/2015 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof Anoop Chauhan
Scientific
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
| Study design | Multi-centre randomised non-blinded parallel group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Patient information can be found at http://www.respect-meso.org/patients%20and%20carers.htm |
| 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 hypothesis | 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 |
| Condition | 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 | 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 outcome measures | 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 |
| Overall study start date | 12/01/2014 |
| Overall study end date | 31/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 174 patients |
| Total final enrolment | 174 |
| Participant 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 |
| Participant 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. |
| Recruitment start date | 03/03/2014 |
| Recruitment end date | 30/09/2016 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
- Wales
Study participating centres
Queen Alexandra Hospital
PO6 3LY
United Kingdom
United Kingdom
Norfolk & Norwich University Hospital
NR4 7UY
United Kingdom
United Kingdom
University Hospital of North Durham & Darlington Hospital
DH1 5TW
United Kingdom
United Kingdom
North Manchester General Hospital
M8 5RB
United Kingdom
United Kingdom
South Tyneside District Hospital
NE34 0PL
United Kingdom
United Kingdom
New Cross Hospital
WV10 0QP
United Kingdom
United Kingdom
Broomfield Hospital
CM1 7ET
United Kingdom
United Kingdom
Southmead Hospital
BS10 5NB
United Kingdom
United Kingdom
Royal Gwent Hospital
NP20 2UB
United Kingdom
United Kingdom
Great Western Hospital
SN3 6BB
United Kingdom
United Kingdom
Musgrove Park Hospital
TA1 5DA
United Kingdom
United Kingdom
Wythenshawe Hospital
M23 9LT
United Kingdom
United Kingdom
Basildon Hospital
SS16 5NL
United Kingdom
United Kingdom
City Hospital & Sandwell Hospital
B71 4HJ
United Kingdom
United Kingdom
Southampton General Hospital
SO16 6YD
United Kingdom
United Kingdom
Sir Charles Gairdner Hospital
6009
Australia
Australia
Royal Hampshire County Hospital
SO22 5DG
United Kingdom
United Kingdom
North Tyneside General Hospital
NE29 8NH
United Kingdom
United Kingdom
Sponsor information
Portsmouth Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Kate Greenwood
Research and Development Department
Research Office
First Floor, Gloucester House
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
| Phone | +44 (0)23 9228 6236 |
|---|---|
| research.office@porthosp.nhs.uk | |
| Website | http://www.porthosp.nhs.uk/departments/Research/research-innovation.htm |
"ROR" |
https://ror.org/009fk3b63 |
Funders
Funder type
Charity
British Lung Foundation (UK) - Asbestos Project Grant Ref.: APG12-13
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BLF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2015 poster abstract presented at 13th Annual British Thoracic Oncology Group Conference: https://www.lungcancerjournal.info/article/S0169-5002(15)50176-1/abstract |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Protocol article | protocol | 19/09/2014 | Yes | No | |
| Results article | results | 01/04/2019 | 09/08/2019 | Yes | No |
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.
