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OpenTrials
Completed

NCT Number: NCT03235999

The Experiences of Patients Living With Malignant Pleural Effusions

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

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Key information

Conditions

Malignant Pleural Effusion Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gloucestershire Hospitals NHS Foundation Trust

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2017
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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