The Experiences of Patients Living With Malignant Pleural Effusions

Malignant Pleural Effusion Clinical Trial

Official title:

The Experiences of Patients Living With Malignant Pleural Effusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235999
• Other study ID #: 16/009/GHT
• Status: Recruiting
• Start date: July 2016
• Est. completion date: January 2019

Study information

• Verified date: August 2018
• Source: Gloucestershire Hospitals NHS Foundation Trust
• Contact: Mark Walker
• Phone: +44300 4225463
• Email: mark.walker[@]glos.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Locations

Country	Name	City	State
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Cheltenham	Gloucestershire

Sponsors (1)

Lead Sponsor	Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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