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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03068117




Registration number
NCT03068117
Ethics application status
Date submitted
4/01/2017
Date registered
1/03/2017
Date last updated
13/06/2019

Titles & IDs
Public title
Malignant Mesothelioma - Can we Improve Quality of Life
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"
Secondary ID [1] 0 0
PHT/2013/46
Universal Trial Number (UTN)
Trial acronym
RESPECT-Meso
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mesothelioma, Malignant 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Regular Early Specialist Symptom Control Treatment (RESSCT)

Experimental: RESSCT plus Standard Care/Therapy - 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.

No Intervention: Standard Care/Therapy - 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.


Other interventions: Regular Early Specialist Symptom Control Treatment (RESSCT)
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline & 24 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline 12 & 24 weeks
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, 12 & 24 weeks
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline, 12 & 24 weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
From randomisation to death or end of study (whichever occurs first), assessed up to 38 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
up to 24 weeks post patients death
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
12 & 24 weeks and 24 weeks post mortality

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
WA 6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Durham
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Essex
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Hampshire
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Norfolk
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Nottinghamshire
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Somerset
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Suffolk
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Tyne And Wear
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Wiltshire
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Bristol
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Manchester
Country [12] 0 0
United Kingdom
State/province [12] 0 0
South Shields
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Portsmouth Hospitals NHS Trust
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
British Lung Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Oxford
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03068117
Trial related presentations / publications
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.
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.
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. Epub 2005 Jul 6.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Prof Anoop J Chauhan, PhD, FRCP
Address 0 0
Portsmouth Hospitals NHS Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications