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

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ClinicalTrials.gov Identifier: NCT03068117
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
British Lung Foundation
University of Oxford
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

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).


Condition or disease Intervention/treatment Phase
Mesothelioma, Malignant Other: Regular Early Specialist Symptom Control Treatment (RESSCT) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : March 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other: 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.

Other Name: Regular Early Specialist Palliative Care

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.



Primary Outcome Measures :
  1. EORTC C-30 Quality of Life [ Time Frame: 12 weeks ]
    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 :
  1. Health Related Quality of Life (HRQoL) in Patients [ Time Frame: Baseline & 24 weeks ]

    The following questionnaire will be used to measure HRQoL in patients;

    - EORTC C-30

    This will be completed at baseline & 24 weeks following randomisation.


  2. Health Related Quality of Life (HRQoL) in Patients [ Time Frame: Baseline 12 & 24 weeks ]

    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.


  3. Health Related Quality of Life (HRQoL) in Patients [ Time Frame: Baseline, 12 & 24 weeks ]

    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.


  4. Patient Mood [ Time Frame: Baseline, 12 & 24 weeks ]

    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.


  5. Primary Caregiver Health Related Quality of Life (HRQoL) [ Time Frame: Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient. ]

    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.


  6. Primary Caregiver Mood [ Time Frame: Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient. ]

    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.


  7. Overall Survival between the two study groups [ Time Frame: From randomisation to death or end of study (whichever occurs first), assessed up to 38 months ]
    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.

  8. Healthcare Utilisation between the two study groups [ Time Frame: up to 24 weeks post patients death ]
    Healthcare resource use will be obtained from hospital, hospice and primary care databases after patient death or End of Study.

  9. Primary caregiver satisfaction with end of life care [ Time Frame: 12 & 24 weeks and 24 weeks post mortality ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068117


Locations
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, WA 6009
United Kingdom
County Durham and Darlington NHS Foundation Trust
County Durham, Durham, United Kingdom, DL3 6HX
Basildon and Thurrock University Hospitals NHS Foundation Trust - Basildon Hospital
Basildon, Essex, United Kingdom, SS16 5NL
Mid Essex Hospital Services NHS Trust - Broomfield Hospital
Chelmsford, Essex, United Kingdom, CM1 7ET
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom, PO6 3LY
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Sherwood Forest Hospitals NHS Foundation Trust
Nottingham, Nottinghamshire, United Kingdom, NG17 4JL
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital
Taunton, Somerset, United Kingdom, TA1 5DA
Ipswich Hospital NHS Trust
Ipswich, Suffolk, United Kingdom, IP4 5PD
Northumbria Healthcare NHS Foundation Trust
North Shields, Tyne and Wear, United Kingdom, NE29 8NH
Great Western Hospital NHS Foundation Trust
Swindon, Wiltshire, United Kingdom, SN3 6BB
North Bristol NHS Trust - Southmead Hospital
Bristol, United Kingdom, BS10 5NB
University Hospital of South Manchester NHS Trust
Manchester, United Kingdom, M23 9LT
Pennine Acute Hospitals NHS Trust
Manchester, United Kingdom, M8 5RB
South Tyneside NHS Foundation Trust
South Shields, United Kingdom, NE34 OPL
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
British Lung Foundation
University of Oxford
Investigators
Principal Investigator: Prof Anoop J Chauhan, PhD, FRCP Portsmouth Hospitals NHS Trust

Additional Information:
Publications:
Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03068117     History of Changes
Other Study ID Numbers: PHT/2013/46
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Portsmouth Hospitals NHS Trust:
Specialist Palliative Care
Symptom Control
Early Referral
Quality of Life
Malignant Pleural Mesothelioma
Mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases