The Experiences of Patients Living With Malignant Pleural Effusions

Sponsor

Gloucestershire Hospitals NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT03235999

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malignant Pleural Effusion

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Experiences of Patients Living With Malignant Pleural Effusions

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Talc pleurodesis Up to 10 patients who have had talc pleurodesis
IPC Up to 10 patients who have had indwelling pleural catheters (IPC)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gloucestershire Hospitals NHS Foundation Trust	Cheltenham	Gloucestershire	United Kingdom	GL53 7AN

Sponsors and Collaborators

Gloucestershire Hospitals NHS Foundation Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gloucestershire Hospitals NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT03235999

Other Study ID Numbers:

16/009/GHT

First Posted:

Aug 1, 2017

Last Update Posted:

Aug 2, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pleural Effusion, Malignant

Pleural Effusion

Study Results

No Results Posted as of Aug 2, 2018