An observational study in Indwelling Pleural Catheter, sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust · Observational
A pleural effusion is a build-up of fluid around the lung. In the UK, about quarter of a million people develop a pleural effusion each year. They are usually caused by advanced cancer or heart, kidney, or liver failure. People with a pleural effusion feel breathless and can't do the things they want to. Draining the fluid improves breathlessness and quality of life. This can be done by inserting a semi-permanent tube called an indwelling pleural catheter (IPC). This is drained at home about three times a week.
Drainage is usually done by a community nurse. However, it can be done by the patient or family/unpaid carers - this is called self-management. Self-management gives the patient the freedom to drain their IPC when they need to, without having to wait at home until a nurse is available. It reduces the burden on community nursing services. Despite these benefits, not all patients get the opportunity to self-manage.
The aim of this study is to help more patients self-manage if they want to. We will achieve this through three stages:
Stage 1: We will talk to patients with IPCs as well as their families/carers to find out their views on self-management and what stops people who could self-manage from doing so. We know that patients with an IPC can be frail. Often their families/carers are already doing a lot to support them. We will ask what might help them to self-manage if they would like to.
Stage 2: We will talk to healthcare professionals (HCPs) looking after patients with IPCs to understand what they think about self-management. This will include community nurses and the hospital teams who put IPCs in.
Stage 3: Along with our patients, their families/unpaid carers and HCPs, we will hold workshops to design an intervention that will help people to self-manage IPCs. We don't know what this intervention will look like yet. From talking to patients and families who already self-manage, we have found they like to learn from a demonstration on their own IPC followed by supervised self-management until they feel confident. Therefore, our intervention may include training sessions for HCPs on how to teach self-management.
This study grew from conversations with our patients. People with an IPC, family members and community nurses helped design the study. Our patient and public involvement (PPI) group will help design study materials and guide the study.
Research question:
How can patients with an indwelling pleural catheter (IPC) and their family/unpaid carers be supported to self-manage?
Background:
Pleural effusion is the accumulation of fluid in the space between the lung and chest wall. It is a common complication of malignancy and affects approximately 200-250,000 people annually in the UK. People with such an effusion experience disabling breathlessness; this is treated by draining the fluid using IPCs (semi-permanent chest drains). These are usually managed at home by community nurses, but this can be done by the patient, family member or carer. Supported self-management is part of the NHS long term plan and British Thoracic Society guidelines state that patients should be supported to self-manage their IPC to promote independence. However, there is no evidence to support these recommendations, nor guidance on how self-management should be facilitated. There is thus an evidence gap at the heart of current recommendations.
Objectives:
O1. Identify support needs of patients with IPCs and their family/unpaid carers and how these impact on the acceptability and feasibility of self-management.
O2. Identify barriers and motivators to IPC self-management among patients and family/unpaid carers.
O3. Understand healthcare professional (HCP) attitudes toward, and practices related to, IPC self-management.
O4. Co-design and develop an evidence-based intervention to facilitate IPC self-management.
Methods:
An applied qualitative study and co-design project comprising three stages mapped to the four objectives.
S1: semi-structured interviews with patients with an IPC and their family/unpaid carers regarding self-management and support needs.
S2: focus groups and interviews with community nurses and IPC service staff regarding self-management.
S3: co-design and development of a self-management intervention.
Interviews will be audio- or audiovisual-recorded (with permission), transcribed, and analysed using thematic analysis. Codes will be assigned to text to categorise meanings. Given the lack of prior research, the coding schema will be developed inductively from early transcripts (with reference to literature from other fields), refined and applied to subsequent transcripts. Codes will be categorised, themes identified, and the results developed into a narrative. The COM-B system will be the model of reference for the development of the self-management intervention. This is comprised of a behaviour change wheel linked to intervention functions and policy categories.
Inclusion criteria Stage 1 - patients and family/unpaid carers
Exclusion criteria Stage 1 - patients
Anticipated Impact and Dissemination
The principal output will be a prototype self-management intervention for patients with an IPC and their family/unpaid carers that will:
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 116 is below the median of 140 across 93 observational studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Norfolk and Norwich University Hospitals NHS Foundation Trust is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
UK patients who have (or have had) an indwelling pleural catheter, and their family/unpaid carers. UK healthcare professionals who work with patients who have IPCs, including community nurses and IPC-insertion centre staff.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stage 1 - Patients and family/unpaid carers
Stage 2 - Healthcare professionals
Stage 3 - Co-design groups
o as above
Exclusion Criteria:
Stage 1 - Patients
Stage 2 - Health care professionals o None
Stage 3 - Co-design groups
o As above
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have (or have had) an IPC.
Family members and unpaid carers of patients who have (or have had) an IPC.
Community nurses involved in IPC care and healthcare professionals involved in IPC insertion.
Capturing Health Care Professionals attitudes toward and beliefs about self-management
Data will be collected via focus groups and interviews. The different data collection designs reflect the nature of how the two groups of HCPs work and working patterns. The topic guide for the two activities will thus be largely the same and given the common subject matter it will be possible to analyse the qualitative data from these two approaches together. There will be some additional, group-specific, questions reflecting the different roles these two HCP groups play in the patient care pathway. The four objectives to achieve this are: 1. to identify support needs in relation to IPC and how unfulfilled needs impact ability to self-manage. 2. to identify barriers and motivators to IPC self-management among patients and family/unpaid carers. 3. to understand HCP attitudes toward, and practices related to, IPC-self-management. 4. to work with stakeholders to co-develop an intervention to facilitate IPC self-management.
Time frame: Periprocedural
Plan to share: Yes — The study will be publicised to stakeholders. Online resources may be hosted and promoted via the MyPleuralEffusionJourney and UKPS websites. Further opportunities for promotion will be explored including direct contact with services previously identified as using self-management infrequently.
Supporting information: Clinical study report
Time frame: Throughout study duration.
Access criteria: Stakeholders including - but not limited to: Regional integrated care boards, and participating NHS trusts / study recruitment sites. Influential third sector organisations such as Mesothelioma UK IPC manufacturers Relevant charities such as Breast Cancer UK and the Roy Castle lung cancer foundation. Via the FutureNHS platform. Members of the BTS Pleural Guideline Development group
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Apr 2026, 17 months after the start.
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Norfolk and Norwich University Hospitals NHS Foundation Trust