Clinical Trial

Indwelling Pleural Catheters: a Self-management Intervention

Study acronym: PACMAN
Enrolling by Invitation
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Record status
This record was last updated April 11, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
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. 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-27.
Trial Details
NCT Number NCT06910800
Lead Sponsor Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborators: University of East Anglia
Conditions Indwelling Pleural Catheter
Enrollment 116 participants
Start Date 2024-11-12
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-11