Malignant pleural effusion Cancer Secondary malignant neoplasm of pleura
Conditions
Interventions
Patients with a malignant pleural effusion will be identified from clinic lists, procedure lists and inpatient wards by clinicians working in pleural services. Patients will be screened using the incl
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Symptomatic pleural effusion and any of the following: 1.1. Thoracoscopically confirmed evidence of malignant pleural disease (visible cancer at thoracoscopy) which requires talc poudrage as part of routine clinical care 1.2. An established diagnosis of malignant pleural effusion (via biopsy or cytology) which requires drainage and pleurodesis as per standard care, where the patient/operator decide on a thoracoscopic treatment 1.3. Symptomatic effusion requiring drainage and pleurodesis in the context of established metastatic disease 2. Able to consent to trial inclusion
Exclusion criteria
Exclusion criteria: 1. Technically unable to undergo thoracoscopy and talc poudrage (e.g. gross respiratory failure, uncorrectable clotting, unable to tolerate position, significant suspicion of underlying trapped lung or poor performance status) 2. Visual impairment (precluding use of symptom measurement instruments) 3. Previous talc pleurodesis within the last 3 months on ipsilateral side 4. No means of phone contact 5. Age <18 years 6. Females who are pregnant or lactating 7. Unable to consent to trial inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary outcomes are: 1. Total number of days spent in hospital (including re-admissions) captured from patient diaries and medical records over 4 weeks post-procedure 2. Breathlessness score over 4 weeks post-procedure measured using a 100 mm visual analogue score (VAS) at baseline and then twice weekly for 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean chest pain score over 4 weeks post-procedure measured using a 100 mm visual analogue score (VAS) at baseline then twice weekly for 4 weeks 2. Total number of days spent in hospital captured from patient diaries and medical records over 12 weeks post-procedure 3. Total number of days until medically appropriate for discharge from hospital over 4 and 12 weeks post-procedure according to discharge criteria specified in the protocol and trial-specific procedures 4. Number of patients with successful pleurodesis, defined as absence of pleural effusion of at least moderate size defined radiologically (greater than or equal to 1/3rd of hemithorax on CXR, or >2 rib spaces and 4 cm depth on ultrasound) AND a. Lack of clinical need for further pleural procedure as judged by local investigator* OR b. For IPC patients, fluid output of <50 ml on three consecutive drainages. Measured at 4 and 12 weeks post-procedure 5. Number of contacts with healthcare professionals concerning malignant pleural effusion management, captured from patient diaries and medical records at 12 weeks post-discharge from hospital following the initial procedure 6. Quality of life measured using EQ5D-5L and EORTC QLQc30 at baseline, 4 and 12 weeks post-procedure 7. Healthcare costs and cost-effectiveness of the interventions: 7.1. Costs incurred over 12 weeks from the NHS perspective: drains (IPC and large bore drain), further thoracoscopic talc pleurodesis (TTP) interventions, inpatient, outpatient, emergency, primary care visits 7.2. Cost-effectiveness: within-trial cost-utility analysis to explore incremental cost per QALY gained of TTP+IPC compared to TTP alone Measured at 4 and 12 weeks post-procedure 8. Caregiver burden during post-procedure care assessed using SF-36, GHQ12, WPAI(CG) questionnaires and a five-item caregiving scale at baseline, 4 and 12 weeks after the patients trial procedure (optional aspect of trial for patients primary caregiver) 9. Experience and impact on patients and | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactEmma Hedley
Outcome results
None listed