The Experiences of Patients Living With Malignant Pleural Effusions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03235999

Enrollment

Registered

2017-08-01

Start date

2016-06-02

Completion date

2019-01-14

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Effusion

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient Experiences of living with malignant pleural effusion and different pleural procedures	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.

Countries

United Kingdom

Outcome results