The Experiences of Patients Living With Malignant Pleural Effusions

NCT03235999 | Completed

• 1 other identifier: 16/009/GHT
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 20 patients with malignant pleural effusions will be interviewed about their experiences of having this condition and its management.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Patient Experiences of living with malignant pleural effusion and different pleural procedures

  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

Study Arms (2)

Talc pleurodesis

Up to 10 patients who have had talc pleurodesis

IPC

Up to 10 patients who have had indwelling pleural catheters (IPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant pleural effusions

You may qualify if:

• Adults diagnosed with a malignant pleural effusion
• Has undergone either talc pleurodesis or IPC
• Have signed a consent form prior to entering the study
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Paul Perkins, MBBCh

  Gloucestershire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: August 1, 2017
• Study Start: June 2, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 14, 2019
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)