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The Experiences of Patients Living With Malignant Pleural Effusions

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ClinicalTrials.gov Identifier: NCT03235999
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Gloucestershire Hospitals NHS Foundation Trust

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
Malignant Pleural Effusion

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Experiences of Patients Living With Malignant Pleural Effusions
Study Start Date : July 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Group/Cohort
Talc pleurodesis
Up to 10 patients who have had talc pleurodesis
IPC
Up to 10 patients who have had indwelling pleural catheters (IPC)



Primary Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with malignant pleural effusions
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235999


Contacts
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Contact: Mark Walker +44300 4225463 mark.walker@glos.nhs.uk

Locations
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United Kingdom
Gloucestershire Hospitals NHS Foundation Trust Recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
Contact: Mark Walker    +44300 4225463    mark.walker@glos.nhs.uk   
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Paul Perkins, MBBCh Gloucestershire Hospitals NHS Foundation Trust

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Responsible Party: Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03235999     History of Changes
Other Study ID Numbers: 16/009/GHT
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms