<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235999</url>
  </required_header>
  <id_info>
    <org_study_id>16/009/GHT</org_study_id>
    <nct_id>NCT03235999</nct_id>
  </id_info>
  <brief_title>The Experiences of Patients Living With Malignant Pleural Effusions</brief_title>
  <official_title>The Experiences of Patients Living With Malignant Pleural Effusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gloucestershire Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gloucestershire Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 20 patients with malignant pleural effusions will be interviewed about their&#xD;
      experiences of having this condition and its management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Experiences of living with malignant pleural effusion and different pleural procedures</measure>
    <time_frame>4 weeks after IPC placement or talc pleurodesis</time_frame>
    <description>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.&#xD;
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.&#xD;
There will be no numerical, quantitative data for analysis.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Malignant Pleural Effusion</condition>
  <arm_group>
    <arm_group_label>Talc pleurodesis</arm_group_label>
    <description>Up to 10 patients who have had talc pleurodesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPC</arm_group_label>
    <description>Up to 10 patients who have had indwelling pleural catheters (IPC)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with malignant pleural effusions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults diagnosed with a malignant pleural effusion&#xD;
&#xD;
          2. Has undergone either talc pleurodesis or IPC&#xD;
&#xD;
          3. Have signed a consent form prior to entering the study&#xD;
&#xD;
          4. Life expectancy &gt; 6 weeks based on LENT guidelines (Low/Moderate risk group) - The&#xD;
             LENT score calculation assigns 0 (&lt;1500 IU/L) or 1 (&gt;1500 IU/L) for pleural fluid LDH&#xD;
             level; 0 to 3 points for matching ECOG performance scores (3 and 4 are combined); 0&#xD;
             (&lt;9) or 1 (&gt;9) for neutrophil-to-lymphocyte ratio; and 0 (lowest risk), 1 (moderate&#xD;
             risk), or 3 (highest risk) for tumor type.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any patient who is unable to understand sufficient English to take part in the&#xD;
             semi-structured interviews&#xD;
&#xD;
          2. Weakness or fatigue sufficient so that the patient is unable to take part in the&#xD;
             interviews&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Perkins, MBBCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gloucestershire Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mark Walker</last_name>
    <phone>+44300 4225463</phone>
    <email>mark.walker@glos.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gloucestershire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cheltenham</city>
        <state>Gloucestershire</state>
        <zip>GL53 7AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Walker</last_name>
      <phone>+44300 4225463</phone>
      <email>mark.walker@glos.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>April 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235999
org study id: 16/009/GHT
nct id: NCT03235999
lead sponsor: 
has dmc: No
Up to 20 patients with malignant pleural effusions will be interviewed about their
      experiences of having this condition and its management.
observational model: Cohort
time perspective: Prospective
measure: Patient Experiences of living with malignant pleural effusion and different pleural procedures
time frame: 4 weeks after IPC placement or talc pleurodesis
description: 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.
arm group label: Talc pleurodesis
description: Up to 10 patients who have had talc pleurodesis
arm group label: IPC
description: Up to 10 patients who have had indwelling pleural catheters (IPC)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Perkins, MBBCh
role: Principal Investigator
affiliation: Gloucestershire Hospitals NHS Foundation Trust
last name: Mark Walker
phone: +44300 4225463
email: mark.walker@glos.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion
sharing ipd: No