Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Participants will receive early referral to an anesthesia-trained interventional pain management specialist evaluated for pain management strategies.

Participants will complete surveys every 2 months and will have the option of tracking their pain at home using a secure smartphone application.

Participants will be followed on the study for 4 months.

Directing a patient for a pain specialist consult earlier than standardly occurs.

Early Referral

Specialized plan with procedures to ease pain

Pain Management Strategies

Andrea Enzinger, MD

The purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer.

This is a single arm pilot study evaluating a new system of referral and pain evaluation for patients with advanced solid tumors and moderate-to-severe pain who are not already on high-dose opioids to an anesthesia-trained interventional pain management specialist .

A variety of interventional treatments for pain have been proven effective for cancer patients. Often without early referral patients do not get evaluated for interventional procedures for their pain unless the pain is very severe, or they are admitted to the hospital. It is expect this intervention will work by providing effective pain treatments to patients sooner than they might normally be referred and will be evaluated by how many patients are candidates for interventional treatments for their pain, whether patients choose to receive these treatments, and whether patients find the pain specialist referral acceptable and helpful

The research study procedures include screening for eligibility, study interventions including evaluations and follow up visits, as well as surveys at the beginning, middle, and end of the study. Participants will be followed on the study for 4 months.

It is expected that about 30 people will take part in this research study.

Medtronic and is providing funding for this research study

Early Interventional Treatment for Cancer Pain

Pilot Study of Early Referral to Interventional Pain Management for Patients With Advanced Malignancies

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Primary outcome is feasibility and acceptability. Feasibility and acceptability will be measured by the proportion of patients that undergo an interventional pain consultation within 4 weeks: \>80%

Primary outcome is feasibility and acceptability. Feasibility and acceptability will be measured by the proportion of patients referred and evaluated by an anesthesia pain specialist, at least 50% will agree and ultimately receive at least one interventional pain procedure

Primary outcome is feasibility and acceptability. Feasibility and acceptability will be measured by the proportion of patients satisfied with their interventional pain management care, at least 80% of patients will be satisfied with their care defined as rating it a 4 or 5 on a 5-point Likert scale.

Medtronic

Dana-Farber Cancer Institute

Principal Investigator

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

Malignant Mesothelioma

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.

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.

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.

Regular Early Specialist Symptom Control Treatment (RESSCT)

Prof Anoop J Chauhan, PhD, FRCP

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).

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.

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"

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.

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

- EORTC C-30

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

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.

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.

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.

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.

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.

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.

Healthcare resource use will be obtained from hospital, hospice and primary care databases after patient death or End of Study.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Interventional Treatment for Cancer Pain	NCT05366413	Cancer Pain	Early Referral Pain Management...	18 Years -	Dana-Farber Cancer Institute
Malignant Mesothelioma - Can we Improve Quality of Life	NCT03068117	Mesothelioma, M...	Regular Early S...	18 Years -	Portsmouth Hospitals NHS Trust
Early Interventional Treatment for Cancer Pain	NCT05366413	Cancer Pain	Early Referral Pain Management...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for early referral