Clinical trial · Interventional
Malignant Mesothelioma - Can we Improve Quality of Life
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"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma, Malignant | Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regular Early Specialist Symptom Control Treatment (RESSCT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RESSCT plus Standard Care/Therapy
- description
- 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.
- interventionNames
- Other: Regular Early Specialist Symptom Control Treatment (RESSCT)
- type
- NO_INTERVENTION
- label
- Standard Care/Therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDTemel 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. PMID 20818875
- BACKGROUNDHollen 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. PMID 15274072
- BACKGROUNDHollen 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. PMID 15999264
- BACKGROUNDLangendijk 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. PMID 10788684
- BACKGROUNDMontazeri 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. PMID 11165402