<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/NCT04466020</url>
  </required_header>
  <id_info>
    <org_study_id>KCH20-056</org_study_id>
    <secondary_id>ICA-CL-2018-04-ST2-001</secondary_id>
    <nct_id>NCT04466020</nct_id>
  </id_info>
  <brief_title>SELF - BREATHE for Chronic Breathlessness</brief_title>
  <official_title>A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College Hospital NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Semi-structured qualitative interviews will be conducted to understand key factors that would&#xD;
      enable / facilitate patients with chronic breathlessness to potentially use an online&#xD;
      breathlessness intervention (SELF-BREATHE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY OVERVIEW&#xD;
&#xD;
      Full title:&#xD;
&#xD;
      A self -guided, internet -based intervention for patients with chronic breathlessness&#xD;
      (SELF-BREATHE): an interview study.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To understand the key factors that would enable / facilitate patients with chronic&#xD;
      breathlessness to use an online breathlessness support intervention (SELF-BREATHE).&#xD;
&#xD;
      Study type:&#xD;
&#xD;
      Qualitative interview study&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Semi-structured qualitative interviews will be conducted to achieve maximum variation in&#xD;
      approx 20 patients with chronic breathlessness (a purposive sample: age sex, diagnoses, and&#xD;
      presence of caregiver).&#xD;
&#xD;
      The interview will explore and identify:&#xD;
&#xD;
      Patients' views/experiences of internet-based activities, e.g. digital apps, shopping online;&#xD;
      Patients' understanding, preferences, values and motivations that would influence uptake of&#xD;
      SELF-BREATHE; Potential barriers to the development and use of SELF-BREATHE; Facilitators to&#xD;
      usage of SELF-BREATHE, such as the ability to self-monitor progress etc...&#xD;
&#xD;
      These topics cover areas of uncertainty in order to optimise the SELF - BREATHE intervention.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      Adult patients &gt;18 years of age, with the ability to read, converse in English and able to&#xD;
      provide informed consent&#xD;
&#xD;
      Chronic breathlessness on exertion and or rest (MRC dysponea score &gt;2)&#xD;
&#xD;
      Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart&#xD;
      failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to&#xD;
      be optimally medically managed by the referring clinician / allied health professional /&#xD;
      clinical nurse specialist&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      Breathlessness of unknown cause&#xD;
&#xD;
      A primary diagnosis of chronic hyperventilation syndrome&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Descriptive qualitative analysis of patients' preferences, values and motivations that would influence the use of an online self - management intervention for chronic breathlessness (SELF-BREATHE).</measure>
    <time_frame>12 months</time_frame>
    <description>Qualitative data</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>COPD</condition>
  <condition>Cancer</condition>
  <condition>Heart Failure</condition>
  <condition>Interstitial Disease</condition>
  <condition>Dyspnea</condition>
  <arm_group>
    <arm_group_label>Patients with Chronic Breathlessness</arm_group_label>
    <description>Patients with Chronic Breathlessness</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualitative research interviews to be conducted</intervention_name>
    <description>None. Qualitative research interviews to be conducted</description>
    <arm_group_label>Patients with Chronic Breathlessness</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COPD, Cancer, Heart Failure, Interstitial Lung disease, Dyspnea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients &gt;18 years of age, with the ability to read, converse in English and&#xD;
             able to provide informed consent&#xD;
&#xD;
          -  Chronic breathlessness on exertion and or rest (MRC dyspnea score &gt;2)&#xD;
&#xD;
          -  Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic&#xD;
             heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease&#xD;
             is deemed to be optimally medically managed by the referring clinician / allied health&#xD;
             professional / clinical nurse specialist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breathlessness of unknown cause&#xD;
&#xD;
          -  A primary diagnosis of chronic hyperventilation syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles C Reilly, PhD,MSc,BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College Hospital NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</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>Dyspnea</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/NCT04466020
org study id: KCH20-056
secondary id: ICA-CL-2018-04-ST2-001
nct id: NCT04466020
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Semi-structured qualitative interviews will be conducted to understand key factors that would
      enable / facilitate patients with chronic breathlessness to potentially use an online
      breathlessness intervention (SELF-BREATHE).
STUDY OVERVIEW

      Full title:

      A self -guided, internet -based intervention for patients with chronic breathlessness
      (SELF-BREATHE): an interview study.

      Objective:

      To understand the key factors that would enable / facilitate patients with chronic
      breathlessness to use an online breathlessness support intervention (SELF-BREATHE).

      Study type:

      Qualitative interview study

      Methods:

      Semi-structured qualitative interviews will be conducted to achieve maximum variation in
      approx 20 patients with chronic breathlessness (a purposive sample: age sex, diagnoses, and
      presence of caregiver).

      The interview will explore and identify:

      Patients' views/experiences of internet-based activities, e.g. digital apps, shopping online;
      Patients' understanding, preferences, values and motivations that would influence uptake of
      SELF-BREATHE; Potential barriers to the development and use of SELF-BREATHE; Facilitators to
      usage of SELF-BREATHE, such as the ability to self-monitor progress etc...

      These topics cover areas of uncertainty in order to optimise the SELF - BREATHE intervention.

      Inclusion criteria:

      Adult patients >18 years of age, with the ability to read, converse in English and able to
      provide informed consent

      Chronic breathlessness on exertion and or rest (MRC dysponea score >2)

      Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart
      failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to
      be optimally medically managed by the referring clinician / allied health professional /
      clinical nurse specialist

      Exclusion criteria:

      Breathlessness of unknown cause

      A primary diagnosis of chronic hyperventilation syndrome
observational model: Other
time perspective: Prospective
measure: Descriptive qualitative analysis of patients' preferences, values and motivations that would influence the use of an online self - management intervention for chronic breathlessness (SELF-BREATHE).
time frame: 12 months
description: Qualitative data
arm group label: Patients with Chronic Breathlessness
description: Patients with Chronic Breathlessness
intervention type: Other
intervention name: Qualitative research interviews to be conducted
description: None. Qualitative research interviews to be conducted
arm group label: Patients with Chronic Breathlessness
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Charles C Reilly, PhD,MSc,BSc
role: Principal Investigator
affiliation: King's College Hospital NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dyspnea
sharing ipd: No