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Mesothelioma, MalignantRESPECT-MesoNCT03068117

Malignant Mesothelioma - Can we Improve Quality of Life

A study of Mesothelioma, Malignant, run by Portsmouth Hospitals NHS Trust at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma, Malignant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
19 sitesin 2 countries
Study dates
3 Apr 2014to 10 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United Kingdom18 sites

  • Basildon and Thurrock University Hospitals NHS Foundation Trust - Basildon Hospital

    Basildon, Essex, SS16 5NL

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke, Hampshire, RG24 9NA

  • North Bristol NHS Trust - Southmead Hospital

    Bristol, BS10 5NB

  • Mid Essex Hospital Services NHS Trust - Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

  • County Durham and Darlington NHS Foundation Trust

    County Durham, Durham, DL3 6HX

  • Ipswich Hospital NHS Trust

    Ipswich, Suffolk, IP4 5PD

  • University Hospital of South Manchester NHS Trust

    Manchester, M23 9LT

  • Pennine Acute Hospitals NHS Trust

    Manchester, M8 5RB

  • Northumbria Healthcare NHS Foundation Trust

    North Shields, Tyne and Wear, NE29 8NH

  • Norfolk & Norwich University Hospitals NHS Foundation Trust

    Norwich, Norfolk, NR4 7UY

  • Sherwood Forest Hospitals NHS Foundation Trust

    Nottingham, Nottinghamshire, NG17 4JL

  • Nottinghamshire Healthcare NHS Foundation Trust

    Nottingham, Nottinghamshire, NG3 6AA

  • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

    Portsmouth, Hampshire, PO6 3LY

  • South Tyneside NHS Foundation Trust

    South Shields, NE34 OPL

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

  • Great Western Hospital NHS Foundation Trust

    Swindon, Wiltshire, SN3 6BB

  • Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital

    Taunton, Somerset, TA1 5DA

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia1 site

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, WA 6009

Other trials in Australia

About this study

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"

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).

Read the 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.

Being tested
Regular Early Specialist Symptom Control Treatment (RESSCT)
Keywords
Specialist Palliative Care, Symptom Control, Early Referral, Quality of Life, Malignant Pleural Mesothelioma, Mesothelioma
Medical subject headings
Mesothelioma, Malignant, Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular Early Specialist Symptom Control Treatment (RESSCT)Other

    Also called Regular Early Specialist Palliative Care

    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.

Study groups in NCT03068117
Study groupRoleWhat they receive
RESSCT plus Standard Care/TherapyExperimentalRegular 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.
Receives: Other: Regular Early Specialist Symptom Control Treatment (RESSCT)
Standard Care/TherapyNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (9)

  1. 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.

    Measured: Baseline & 24 weeks

  2. 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.

    Measured: Baseline 12 & 24 weeks

  3. 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.

    Measured: Baseline, 12 & 24 weeks

  4. 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.

    Measured: Baseline, 12 & 24 weeks

  5. 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.

    Measured: Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.

  6. 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.

    Measured: Baseline, 12 & 24 weeks & 24 weeks post mortality of the patient.

  7. 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.

    Measured: From randomisation to death or end of study (whichever occurs first), assessed up to 38 months

  8. 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.

    Measured: up to 24 weeks post patients death

  9. 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.

    Measured: 12 & 24 weeks and 24 weeks post mortality

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start3 Apr 2014
  3. Primary completionJan 2017
  4. Study completion10 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03068117
Sponsor's protocol ID
PHT/2013/46
Acronym
RESPECT-Meso
Status last verified
Jun 2019
First submitted
4 Jan 2017
Last updated
13 Jun 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 20818875

  • 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.

    PubMed 15274072

  • 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.

    PubMed 15999264

  • 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.

    PubMed 10788684

  • 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.

    PubMed 11165402

Questions about this trial

What is this clinical trial studying?

A study of Mesothelioma, Malignant, run by Portsmouth Hospitals NHS Trust at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EORTC C-30 Quality of Life (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03068117, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.

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