Clinical trial NCT03068117: Malignant Mesothelioma - Can we Improve Quality of Life
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
Overall status: COMPLETED
Phase: NA
Conditions: Mesothelioma, Malignant
Keywords: Specialist Palliative Care
Symptom Control
Early Referral
Quality of Life
Malignant Pleural Mesothelioma
Mesothelioma
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: British Lung Foundation
name: University of Oxford
First posted: 2017-03-01
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: EORTC C-30 Quality of Life
timeFrame: 12 weeks
Secondary outcomes:
measure: Health Related Quality of Life (HRQoL) in Patients
timeFrame: Baseline & 24 weeks
measure: Health Related Quality of Life (HRQoL) in Patients
timeFrame: Baseline 12 & 24 weeks
measure: Health Related Quality of Life (HRQoL) in Patients
timeFrame: Baseline, 12 & 24 weeks
measure: Patient Mood
timeFrame: Baseline, 12 & 24 weeks
measure: Primary Caregiver Health Related Quality of Life (HRQoL)
timeFrame: Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
measure: Primary Caregiver Mood
timeFrame: Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.
measure: Overall Survival between the two study groups
timeFrame: From randomisation to death or end of study (whichever occurs first), assessed up to 38 months
measure: Healthcare Utilisation between the two study groups
timeFrame: up to 24 weeks post patients death
measure: Primary caregiver satisfaction with end of life care
timeFrame: 12 & 24 weeks and 24 weeks post mortality
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: County Durham
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust
state: Durham
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals NHS Foundation Trust - Basildon Hospital
state: Essex
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital Services NHS Trust - Broomfield Hospital
state: Essex
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
state: Hampshire
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
state: Hampshire
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospitals NHS Foundation Trust
state: Norfolk
city: Nottingham
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Foundation Trust
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Foundation Trust
state: Nottinghamshire
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
state: Somerset
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital NHS Trust
state: Suffolk
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
state: Tyne And Wear
city: Swindon
country: United Kingdom
facility: Great Western Hospital NHS Foundation Trust
state: Wiltshire
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust - Southmead Hospital
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHS Trust
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: South Shields
country: United Kingdom
facility: South Tyneside NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Prof Anoop J Chauhan, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.