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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03068117
Ethics application status
Date submitted
4/01/2017
Date registered
1/03/2017

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
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Health Related Quality of Life (HRQoL) in Patients
Timepoint [1] 0 0
Baseline & 24 weeks
Secondary outcome [2] 0 0
Health Related Quality of Life (HRQoL) in Patients
Timepoint [2] 0 0
Baseline 12 & 24 weeks
Secondary outcome [3] 0 0
Health Related Quality of Life (HRQoL) in Patients
Timepoint [3] 0 0
Baseline, 12 & 24 weeks
Secondary outcome [4] 0 0
Patient Mood
Timepoint [4] 0 0
Baseline, 12 & 24 weeks
Secondary outcome [5] 0 0
Primary Caregiver Health Related Quality of Life (HRQoL)
Timepoint [5] 0 0
Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
Secondary outcome [6] 0 0
Primary Caregiver Mood
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
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
Timepoint [8] 0 0
up to 24 weeks post patients death
Secondary outcome [9] 0 0
Primary caregiver satisfaction with end of life care
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
Sex
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
Other
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
3/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/04/2017
Sample size
Target
Accrual to date
Final
319
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
Government body
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03068117