Indwelling Pleural CatheterPACMANNCT06910800
Indwelling Pleural Catheters: a Self-management Intervention
An observational study of Indwelling Pleural Catheter, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indwelling Pleural Catheter
- How many people
- 116 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Nov 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: 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.
Who may be able to join
- Stage 1 - Patients and family/unpaid carers
- Adult (>18 years) who has (or has had) an IPC OR
- Adult family member or unpaid carer of a patient who has (or has had) an IPC
- Patients may currently be self-managing or receiving CN care.
- Stage 2 - Healthcare professionals
- Community nurse: experience of caring for a patient with an IPC within the last 12 months and signed-off as competent in IPC management
Show all 9Show fewer
- IPC-insertion site staff: any HCP involved in discussion with patients about post-insertion IPC care
- Stage 3 - Co-design groups
- o as above
Who cannot join
- Stage 1 - Patients
- Patient with a life expectancy of less than 6 weeks
- Patient or family/unpaid carer who lacks capacity to offer informed consent (as judged by a suitably qualified HCP in accordance with Good Clinical Practice guidelines)
- Stage 2 - Health care professionals o None
- Stage 3 - Co-design groups
- o As above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Indwelling Pleural Catheters: Co-developing an Intervention to Support Self-Management
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.
Read more
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.
Read the detailed description
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
- Adult (>18 years) who has (or has had) an IPC OR
- Adult family member or unpaid carer of a patient who has (or has had) an IPC
- Patients may currently be self-managing or receiving CN care. Stage 2 - healthcare professionals
- Community nurse: experience of caring for a patient with an IPC within the last 12 months and signed-off as competent in IPC management
- IPC-insertion site staff: any HCP involved in discussion with patients about post-insertion IPC care Stage 3 - co-design groups
- as above
Exclusion criteria Stage 1 - patients
- Patient with a life expectancy of less than 6 weeks
- Patient or family/unpaid carer who lacks capacity to offer informed consent (as judged by a suitably qualified HCP in accordance with Good Clinical Practice guidelines) Stage 2 - Health care professionals
- None Stage 3 - co-design groups
- As above
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:
- Empower patients, increase perceived symptom control, and reduce time spent 'waiting in' for nursing visits;
- Relieve pressure on community nursing services and reduce healthcare costs;
- Support the NHS long term plan by enabling supported self-management;
- Facilitate more frequent drainage which may prevent re-accumulation of pleural fluid.
- Conditions
- Indwelling Pleural Catheter
- Keywords
- Indwelling pleural catheter, Tunnelled pleural catheter, IPC, Pleural effusion, Self-management, Support needs
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have (or have had) an IPC. | |
| Family members and unpaid carers | Family members and unpaid carers of patients who have (or have had) an IPC. | |
| Healthcare professionals | Community nurses involved in IPC care and healthcare professionals involved in IPC insertion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- to identify support needs in relation to IPC and how unfulfilled needs impact ability to self-manage.
- to identify barriers and motivators to IPC self-management among patients and family/unpaid carers.
- to understand HCP attitudes toward, and practices related to, IPC-self-management.
- to work with stakeholders to co-develop an intervention to facilitate IPC self-management.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start12 Nov 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indwelling Pleural CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Adam M Dr Peel, Principal investigator, Norfolk and Norwich University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910800
- Sponsor's protocol ID
- Pac-man protocol | v1.0 | 14.0
- Other IDs
- 333923, 58382
- Acronym
- PACMAN
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indwelling Pleural Catheters: Co-developing an Intervention to Support Self-Management
- ClinicalTrials.gov ID
- NCT06910800
- Acronym / sponsor ID
- PACMAN / Pac-man protocol | v1.0 | 14.0
- Conditions
- Indwelling Pleural Catheter
- Keywords
- Indwelling pleural catheter, Tunnelled pleural catheter, IPC, Pleural effusion, Self-management, Support needs
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Adult (>18 years) who has (or has had) an IPC OR
- Adult family member or unpaid carer of a patient who has (or has had) an IPC
- Patients may currently be self-managing or receiving CN care. Stage 2 - healthcare professionals
- Community nurse: experience of caring for a patient with an IPC within the last 12 months and signed-off as competent in IPC management
- IPC-insertion site staff: any HCP involved in discussion with patients about post-insertion IPC care Stage 3 - co-design groups
- as above
Exclusion criteria Stage 1 - patients
- Patient with a life expectancy of less than 6 weeks
- Patient or family/unpaid carer who lacks capacity to offer informed consent (as judged by a suitably qualified HCP in accordance with Good Clinical Practice guidelines) Stage 2 - Health care professionals
- None Stage 3 - co-design groups
- As above
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:
- Empower patients, increase perceived symptom control, and reduce time spent 'waiting in' for nursing visits;
- Relieve pressure on community nursing services and reduce healthcare costs;
- Support the NHS long term plan by enabling supported self-management;
- Facilitate more frequent drainage which may prevent re-accumulation of pleural fluid.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients who have (or have had) an IPC. |
| Family members and unpaid carers | – | –Family members and unpaid carers of patients who have (or have had) an IPC. |
| Healthcare professionals | – | –Community nurses involved in IPC care and healthcare professionals involved in IPC insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Stage 1 - Patients and family/unpaid carers
- Stage 2 - Healthcare professionals
- Community nurse: experience of caring for a patient with an IPC within the last 12 months and signed-off as competent in IPC management
- IPC-insertion site staff: any HCP involved in discussion with patients about post-insertion IPC care
- Stage 3 - Co-design groups
Key exclusion criteria (6 listed)
- Stage 1 - Patients
- Stage 2 - Health care professionals o None
- Stage 3 - Co-design groups
- o As above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Capturing Health Care Professionals attitudes toward and beliefs about self-management
Time frame: Periprocedural
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam M Dr Peel principal investigator
Norfolk and Norwich University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indwelling Pleural Catheter, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 9 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Capturing Health Care Professionals attitudes toward and beliefs about self-management (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.