Condition category
Cancer
Date applied
12/12/2013
Date assigned
31/01/2014
Last edited
21/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Anoop Chauhan

ORCID ID

Contact details

Portsmouth Hospitals NHS Trust
Department of Respiratory Medicine
Queen Alexandra Hospital
Southwick Hill road
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)23 9228 6000
chief-investigator-ajc@respect-meso.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RESPECT-Meso 6.0, 17/02/2015

Study information

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'

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?

On 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.

Ethics approval

NRES Committee London - Hampstead , 26/01/2012, ref.: 12/LO/0078

Study design

Multi-centre randomised non-blinded parallel group controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information can be found at http://www.respect-meso.org/patients%20and%20carers.htm

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

12/01/2014

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

174 patients

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, United Kingdom

Trial participating centre

Queen Alexandra Hospital
PO6 3LY
United Kingdom

Trial participating centre

Norfolk & Norwich University Hospital
NR4 7UY
United Kingdom

Trial participating centre

University Hospital of North Durham & Darlington Hospital
DH1 5TW
United Kingdom

Trial participating centre

North Manchester General Hospital
M8 5RB
United Kingdom

Trial participating centre

South Tyneside District Hospital
NE34 0PL
United Kingdom

Trial participating centre

New Cross Hospital
WV10 0QP
United Kingdom

Trial participating centre

Broomfield Hospital
CM1 7ET
United Kingdom

Trial participating centre

Southmead Hospital
BS10 5NB
United Kingdom

Trial participating centre

Royal Gwent Hospital
NP20 2UB
United Kingdom

Trial participating centre

Great Western Hospital
SN3 6BB
United Kingdom

Trial participating centre

Musgrove Park Hospital
TA1 5DA
United Kingdom

Trial participating centre

Wythenshawe Hospital
M23 9LT
United Kingdom

Trial participating centre

Basildon Hospital
SS16 5NL
United Kingdom

Trial participating centre

City Hospital & Sandwell Hospital
B71 4HJ
United Kingdom

Trial participating centre

Southampton General Hospital
SO16 6YD
United Kingdom

Trial participating centre

Sir Charles Gairdner Hospital
6009
Australia

Trial participating centre

Royal Hampshire County Hospital
SO22 5DG
United Kingdom

Trial participating centre

North Tyneside General Hospital
NE29 8NH
United Kingdom

Sponsor information

Organisation

Portsmouth Hospitals NHS Trust (UK)

Sponsor details

c/o Kate Greenwood
Research and Development Department
Research Office
First Floor
Gloucester House
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)23 9228 6236
research.office@porthosp.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.porthosp.nhs.uk/departments/Research/research-innovation.htm

Funders

Funder type

Charity

Funder name

British Lung Foundation (UK) - Asbestos Project Grant Ref.: APG12-13

Alternative name(s)

BLF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25238873

Publication citations

  1. Protocol

    Gunatilake S, Brims FJ, Fogg C, Lawrie I, Maskell N, Forbes K, Rahman N, Morris S, Ogollah R, Gerry S, Peake M, Darlison L, Chauhan AJ, 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 protocol for a randomised controlled trial., Trials, 2014, 15, 367, doi: 10.1186/1745-6215-15-367.

Additional files

Editorial Notes