Malignant Mesothelioma - Can we Improve Quality of Life
RESPECT-Meso
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"
1 other identifier
interventional
319
2 countries
19
Brief Summary
Patients with malignant pleural mesothelioma (MPM) frequently have significant physical symptoms, with up to 92% of patients complaining of three or more symptoms at presentation. Such symptom scores are similar to those reported in advanced non small cell lung cancer (NSCLC) and have been demonstrated to correlate with interference with activity and worse quality of life (QOL). Several studies have reported that baseline Quality of Life (QOL) is a significant prognostic factor for survival in NSCLC patients. In 2010, a non-blinded randomised controlled trial of 151 patients in the United States (US) demonstrated an improved QOL, fewer depressive symptoms and improved survival with early, regular specialist palliative care team (SPCT) involvement in addition to their routine care. The RESPECT-Meso study will examine the effect on quality of life following early Specialist Palliative Care (SPC) involvement for Regular Early Symptom Control Treatment (RESSCT) in addition to routine care in patients with newly diagnosed MPM in the United Kingdom (UK).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Typical duration for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2017
CompletedJune 13, 2019
June 1, 2019
2.8 years
January 4, 2017
June 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EORTC C-30 Quality of Life
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.
12 weeks
Secondary Outcomes (9)
Health Related Quality of Life (HRQoL) in Patients
Baseline & 24 weeks
Health Related Quality of Life (HRQoL) in Patients
Baseline 12 & 24 weeks
Health Related Quality of Life (HRQoL) in Patients
Baseline, 12 & 24 weeks
Patient Mood
Baseline, 12 & 24 weeks
Primary Caregiver Health Related Quality of Life (HRQoL)
Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
- +4 more secondary outcomes
Study Arms (2)
RESSCT plus Standard Care/Therapy
EXPERIMENTALRegular Early Specialist Symptom Control Treatment (RESSCT) and Standard Therapy. Participants will be seen within three weeks of randomisation by the Specialist Palliative Care Team (SPCT), (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.
Standard Care/Therapy
NO INTERVENTIONThe standard care/therapy control group will continue to receive all appropriate, standard treatment for Malignant Pleural Mesothelioma (MPM) currently available to them and will be initiated by the patient's General Practitioner (GP), the cancer MDT or lead respiratory physician as required.
Interventions
Participants will be seen within three weeks of randomisation by the Specialist Palliative Care Team (SPCT), (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.
Eligibility Criteria
You may qualify if:
- Histological or cytological confirmation of malignant pleural mesothelioma (MPM)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. (Asymptomatic patients score 0; symptomatic but ambulatory patients score 1)
- The diagnosis of MPM received within the last 6 weeks
- Ability to provide written informed consent in English and comply with trial procedures
You may not qualify if:
- 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)).
- Significant morbidity which the lead physician (or MDT) feel will unduly confound or influence QOL.
- Those patients the MDT judge require referral to the SPCT at the point of diagnosis.
- Concurrent, or less than 3 months, since participation in another non-mesothelioma clinical trial that may affect QOL.
- Participation in a concurrent mesothelioma trial, within 12 weeks after randomisation, that may affect QOL.
- 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.)
- Chemotherapy treatment for MPM initiated prior to consent.
- A significant history of depression / anxiety / psychiatric illness requiring specialist hospital care within the last 12 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Portsmouth Hospitals NHS Trustlead
- British Lung Foundationcollaborator
- University of Oxfordcollaborator
Study Sites (19)
Sir Charles Gairdner Hospital
Nedlands, Western Australia, WA 6009, Australia
County Durham and Darlington NHS Foundation Trust
County Durham, Durham, DL3 6HX, United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust - Basildon Hospital
Basildon, Essex, SS16 5NL, United Kingdom
Mid Essex Hospital Services NHS Trust - Broomfield Hospital
Chelmsford, Essex, CM1 7ET, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, RG24 9NA, United Kingdom
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
Nottingham, Nottinghamshire, NG17 4JL, United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Nottinghamshire, NG3 6AA, United Kingdom
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
Taunton, Somerset, TA1 5DA, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, Suffolk, IP4 5PD, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, Tyne and Wear, NE29 8NH, United Kingdom
Great Western Hospital NHS Foundation Trust
Swindon, Wiltshire, SN3 6BB, United Kingdom
North Bristol NHS Trust - Southmead Hospital
Bristol, BS10 5NB, United Kingdom
University Hospital of South Manchester NHS Trust
Manchester, M23 9LT, United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester, M8 5RB, United Kingdom
South Tyneside NHS Foundation Trust
South Shields, NE34 OPL, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (5)
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PMID: 20818875BACKGROUNDHollen PJ, Gralla RJ, Liepa AM, Symanowski JT, Rusthoven JJ. Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma: using the LCSS-Meso conceptual model for validation. Cancer. 2004 Aug 1;101(3):587-95. doi: 10.1002/cncr.20315.
PMID: 15274072BACKGROUNDHollen PJ, Gralla RJ, Liepa AM, Symanowski JT, Rusthoven JJ. Measuring quality of life in patients with pleural mesothelioma using a modified version of the Lung Cancer Symptom Scale (LCSS): psychometric properties of the LCSS-Meso. Support Care Cancer. 2006 Jan;14(1):11-21. doi: 10.1007/s00520-005-0837-0. Epub 2005 Jul 6.
PMID: 15999264BACKGROUNDLangendijk H, Aaronson NK, de Jong JM, ten Velde GP, Muller MJ, Wouters M. The prognostic impact of quality of life assessed with the EORTC QLQ-C30 in inoperable non-small cell lung carcinoma treated with radiotherapy. Radiother Oncol. 2000 Apr;55(1):19-25. doi: 10.1016/s0167-8140(00)00158-4.
PMID: 10788684BACKGROUNDMontazeri A, Milroy R, Hole D, McEwen J, Gillis CR. Quality of life in lung cancer patients: as an important prognostic factor. Lung Cancer. 2001 Feb-Mar;31(2-3):233-40. doi: 10.1016/s0169-5002(00)00179-3.
PMID: 11165402BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Anoop J Chauhan, PhD, FRCP
Portsmouth Hospitals NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
March 1, 2017
Study Start
April 3, 2014
Primary Completion
January 1, 2017
Study Completion
April 10, 2017
Last Updated
June 13, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share