search
Back to results

Malignant Mesothelioma - Can we Improve Quality of Life (RESPECT-Meso)

Primary Purpose

Mesothelioma, Malignant

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Regular Early Specialist Symptom Control Treatment (RESSCT)
Sponsored by
Portsmouth Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mesothelioma, Malignant focused on measuring Specialist Palliative Care, Symptom Control, Early Referral, Quality of Life, Malignant Pleural Mesothelioma, Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Sir Charles Gairdner Hospital
  • County Durham and Darlington NHS Foundation Trust
  • Basildon and Thurrock University Hospitals NHS Foundation Trust - Basildon Hospital
  • Mid Essex Hospital Services NHS Trust - Broomfield Hospital
  • Hampshire Hospitals NHS Foundation Trust
  • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
  • University Hospital Southampton NHS Foundation Trust
  • Norfolk & Norwich University Hospitals NHS Foundation Trust
  • Sherwood Forest Hospitals NHS Foundation Trust
  • Nottinghamshire Healthcare NHS Foundation Trust
  • Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
  • Ipswich Hospital NHS Trust
  • Northumbria Healthcare NHS Foundation Trust
  • Great Western Hospital NHS Foundation Trust
  • North Bristol NHS Trust - Southmead Hospital
  • University Hospital of South Manchester NHS Trust
  • Pennine Acute Hospitals NHS Trust
  • South Tyneside NHS Foundation Trust
  • The Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RESSCT plus Standard Care/Therapy

Standard Care/Therapy

Arm Description

Regular 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.

The 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Health Related Quality of Life (HRQoL) in Patients
The following questionnaire will be used to measure HRQoL in patients; - EORTC C-30 This will be completed at baseline & 24 weeks following randomisation.
Health Related Quality of Life (HRQoL) in Patients
The following questionnaire will be used to measure HRQoL in patients; - EORTC LC-13 This will be completed at baseline, 12 & 24 weeks following randomisation.
Health Related Quality of Life (HRQoL) in Patients
The following questionnaire will be used to measure HRQoL in patients; - EuroQol-5 Dimension questionnaire (EQ-5D) This will be completed at baseline, 12 & 24 weeks following randomisation.
Patient Mood
The following questionnaire will be used to measure mood in patients; - Global Health Questionnaire (GHQ) 12 This will be completed at baseline, 12 & 24 weeks following randomisation.
Primary Caregiver Health Related Quality of Life (HRQoL)
The following questionnaires will be used to measure HRQoL in primary caregivers; - Short Form 36 item questionnaire (SF-36) This will be completed at baseline, 12 & 24 weeks following randomisation and subsequently at 24 week post patient mortality.
Primary Caregiver Mood
The following questionnaires will be used to measure mood in primary caregivers; - Global Health Questionnaire (GHQ) 12 This will be completed at baseline, 12 & 24 weeks following randomisation and subsequently at 24 week post patient mortality.
Overall Survival between the two study groups
Overall survival from date of randomisation will be compared. Patients alive at the End of the Study will be recorded as 'alive' to ensure there is no missing data.
Healthcare Utilisation between the two study groups
Healthcare resource use will be obtained from hospital, hospice and primary care databases after patient death or End of Study.
Primary caregiver satisfaction with end of life care
Primary caregiver satisfaction with end of life care as assessed by the Family Caregive Survey 2 (FAMCARE-2) questionnaire at 12 & 24 weeks and 24 weeks post mortality of the patient.

Full Information

First Posted
January 4, 2017
Last Updated
June 12, 2019
Sponsor
Portsmouth Hospitals NHS Trust
Collaborators
British Lung Foundation, University of Oxford
search

1. Study Identification

Unique Protocol Identification Number
NCT03068117
Brief Title
Malignant Mesothelioma - Can we Improve Quality of Life
Acronym
RESPECT-Meso
Official 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 Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
April 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Portsmouth Hospitals NHS Trust
Collaborators
British Lung Foundation, University of Oxford

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The purpose of this study is to examine if regular early Specialist Symptom Control Treatment (SSCT) involvement in mesothelioma patients can improve patients' and carers' quality of life (QOL) during their illness. Mesothelioma is a cancer of the lining around the chest wall which is caused by asbestos exposure. The UK has the highest death rate from mesothelioma in the world and mesothelioma will soon account for approximately 1 in 170 of all deaths in the UK. At present, there is no cure. About a third of patients have chemotherapy, which can prolong how long patients live ('survival') by a few months. For many patients, doctors can only offer treatment of symptoms from the cancer, rather than treating the cancer itself. For most patients, survival is usually between 8-12 months. Mesothelioma causes many symptoms including breathlessness, chest pain, weight loss and fatigue. Specialist Palliative Care (SPC) medicine doctors and nurses are specialists in treating symptoms due to life limiting illness. They also provide emotional support for patients and carers. The current practice in the UK is to involve SPC towards the end of a patient's life. A recent study from America examining lung cancer patients showed that involving SPC early in a patient's treatment improved patients' QOL during their illness, and also their survival. Until a cure for, or significant advance in the treatment of, MPM becomes available, attempts to improve the QOL of patients and carers will remain the primary goal of teams managing their care. Recent research examining NSCLC and early SPCT intervention by Temel et al demonstrated that such a novel approach is plausible, possible and effective in improving patients' QOL. This report demonstrated a survival benefit of 2.7 months; if a new chemotherapy drug were to demonstrate such an effect, it would likely be considered a significant breakthrough in the treatment of MPM. Current practice in the UK is to involve SPC towards the final months, and perhaps weeks, of a life-limiting illness. Therefore, the regular early SSCT intervention is well-placed to demonstrate any effects from the proposed intervention. This comprehensive, randomised, multicentre study will examine both patient and caregiver QOL, and the healthcare economic consequences of providing such an intervention. The results of such will be widely applicable to many institutions and patients throughout the UK. This study will randomly divide patients to either all normal treatment and support ('usual care', as is always offered), or usual care and regular SPC consultations from the time of diagnosis. No treatments will be withheld; this study is providing additional support to patients and their families. Patients will be asked to complete a set of questionnaires at the start of the study, and then monthly for up to 6 months. Carers will also complete a set of questionnaires at the start of the study and then at 3 and 6 months. Reported QOL and survival between the two groups will then be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma, Malignant
Keywords
Specialist Palliative Care, Symptom Control, Early Referral, Quality of Life, Malignant Pleural Mesothelioma, Mesothelioma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RESSCT plus Standard Care/Therapy
Arm Type
Experimental
Arm Description
Regular 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.
Arm Title
Standard Care/Therapy
Arm Type
No Intervention
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
Regular Early Specialist Symptom Control Treatment (RESSCT)
Other Intervention Name(s)
Regular Early Specialist Palliative Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
EORTC C-30 Quality of Life
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Health Related Quality of Life (HRQoL) in Patients
Description
The following questionnaire will be used to measure HRQoL in patients; - EORTC C-30 This will be completed at baseline & 24 weeks following randomisation.
Time Frame
Baseline & 24 weeks
Title
Health Related Quality of Life (HRQoL) in Patients
Description
The following questionnaire will be used to measure HRQoL in patients; - EORTC LC-13 This will be completed at baseline, 12 & 24 weeks following randomisation.
Time Frame
Baseline 12 & 24 weeks
Title
Health Related Quality of Life (HRQoL) in Patients
Description
The following questionnaire will be used to measure HRQoL in patients; - EuroQol-5 Dimension questionnaire (EQ-5D) This will be completed at baseline, 12 & 24 weeks following randomisation.
Time Frame
Baseline, 12 & 24 weeks
Title
Patient Mood
Description
The following questionnaire will be used to measure mood in patients; - Global Health Questionnaire (GHQ) 12 This will be completed at baseline, 12 & 24 weeks following randomisation.
Time Frame
Baseline, 12 & 24 weeks
Title
Primary Caregiver Health Related Quality of Life (HRQoL)
Description
The following questionnaires will be used to measure HRQoL in primary caregivers; - Short Form 36 item questionnaire (SF-36) This will be completed at baseline, 12 & 24 weeks following randomisation and subsequently at 24 week post patient mortality.
Time Frame
Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
Title
Primary Caregiver Mood
Description
The following questionnaires will be used to measure mood in primary caregivers; - Global Health Questionnaire (GHQ) 12 This will be completed at baseline, 12 & 24 weeks following randomisation and subsequently at 24 week post patient mortality.
Time Frame
Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
Title
Overall Survival between the two study groups
Description
Overall survival from date of randomisation will be compared. Patients alive at the End of the Study will be recorded as 'alive' to ensure there is no missing data.
Time Frame
From randomisation to death or end of study (whichever occurs first), assessed up to 38 months
Title
Healthcare Utilisation between the two study groups
Description
Healthcare resource use will be obtained from hospital, hospice and primary care databases after patient death or End of Study.
Time Frame
up to 24 weeks post patients death
Title
Primary caregiver satisfaction with end of life care
Description
Primary caregiver satisfaction with end of life care as assessed by the Family Caregive Survey 2 (FAMCARE-2) questionnaire at 12 & 24 weeks and 24 weeks post mortality of the patient.
Time Frame
12 & 24 weeks and 24 weeks post mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Anoop J Chauhan, PhD, FRCP
Organizational Affiliation
Portsmouth Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
WA 6009
Country
Australia
Facility Name
County Durham and Darlington NHS Foundation Trust
City
County Durham
State/Province
Durham
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Facility Name
Basildon and Thurrock University Hospitals NHS Foundation Trust - Basildon Hospital
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Mid Essex Hospital Services NHS Trust - Broomfield Hospital
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Hampshire Hospitals NHS Foundation Trust
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospitals NHS Foundation Trust
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Sherwood Forest Hospitals NHS Foundation Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Nottinghamshire Healthcare NHS Foundation Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG3 6AA
Country
United Kingdom
Facility Name
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Ipswich Hospital NHS Trust
City
Ipswich
State/Province
Suffolk
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
North Shields
State/Province
Tyne And Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Great Western Hospital NHS Foundation Trust
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
North Bristol NHS Trust - Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Pennine Acute Hospitals NHS Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
South Tyneside NHS Foundation Trust
City
South Shields
ZIP/Postal Code
NE34 OPL
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20818875
Citation
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.
Results Reference
background
PubMed Identifier
15274072
Citation
Hollen 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.
Results Reference
background
PubMed Identifier
15999264
Citation
Hollen 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.
Results Reference
background
PubMed Identifier
10788684
Citation
Langendijk 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.
Results Reference
background
PubMed Identifier
11165402
Citation
Montazeri 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.
Results Reference
background

Learn more about this trial

Malignant Mesothelioma - Can we Improve Quality of Life

We'll reach out to this number within 24 hrs