The Experiences of Patients Living With Malignant Pleural Effusions

September 30, 2025 updated by: Gloucestershire Hospitals NHS Foundation Trust
Up to 20 patients with malignant pleural effusions will be interviewed about their experiences of having this condition and its management.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
        • Gloucestershire Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with malignant pleural effusions

Description

Inclusion Criteria:

  1. Adults diagnosed with a malignant pleural effusion
  2. Has undergone either talc pleurodesis or IPC
  3. Have signed a consent form prior to entering the study
  4. Life expectancy > 6 weeks based on LENT guidelines (Low/Moderate risk group) - The LENT score calculation assigns 0 (<1500 IU/L) or 1 (>1500 IU/L) for pleural fluid LDH level; 0 to 3 points for matching ECOG performance scores (3 and 4 are combined); 0 (<9) or 1 (>9) for neutrophil-to-lymphocyte ratio; and 0 (lowest risk), 1 (moderate risk), or 3 (highest risk) for tumor type.

Exclusion Criteria:

  1. Any patient who is unable to understand sufficient English to take part in the semi-structured interviews
  2. Weakness or fatigue sufficient so that the patient is unable to take part in the interviews

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Talc pleurodesis
Up to 10 patients who have had talc pleurodesis
IPC
Up to 10 patients who have had indwelling pleural catheters (IPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Experiences of living with malignant pleural effusion and different pleural procedures
Time Frame: 4 weeks after IPC placement or talc pleurodesis

Qualitative interviews - Interviews will be recorded on a digital audio recorder and then downloaded on to a password protected computer. The interviews will then be sent for transcription using secure email and anonymised.

We will perform thematic analysis on the interview data. This is a process to help explore the experiences of the subject as they describe it rather than looking at how they talk about the experience. Themes will be drawn from the data following coding. Common codes relating to a theme, for example pain, will be identified and examples of text used to demonstrate the theme extracted. This will ensure a wide variety of quotes across the interviews rather than focusing on one main or a subset of interviews. We will use an inductive approach whereby themes will emerge and not be developed in advance. Emerging codes will be checked by the supervisory team.

There will be no numerical, quantitative data for analysis.

4 weeks after IPC placement or talc pleurodesis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paul Perkins, MBBCh, Gloucestershire Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 14, 2019

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malignant Pleural Effusion

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