- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03235999
The Experiences of Patients Living With Malignant Pleural Effusions
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gloucestershire
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Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
- Gloucestershire Hospitals NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Talc pleurodesis
Up to 10 patients who have had talc pleurodesis
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IPC
Up to 10 patients who have had indwelling pleural catheters (IPC)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Experiences of living with malignant pleural effusion and different pleural procedures
Time Frame: 4 weeks after IPC placement or talc pleurodesis
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: Paul Perkins, MBBCh, Gloucestershire Hospitals NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/009/GHT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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