<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/NCT03786653</url>
  </required_header>
  <id_info>
    <org_study_id>CHPAU2018/02</org_study_id>
    <nct_id>NCT03786653</nct_id>
  </id_info>
  <brief_title>Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting (ImHADom)</brief_title>
  <acronym>ImHADom</acronym>
  <official_title>Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RENAULT Patrick Aldo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier de PAU</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>
      This observational prospective monosite study aims to describe, for the first time,&#xD;
      management in a hospital-at-home programme of patients treated by immunotherapy for bronchial&#xD;
      cancer.&#xD;
&#xD;
      The feasibility in good conditions of this management, the patients' quality of life and&#xD;
      their satisfaction will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress&#xD;
      in terms of tumoral answer, survival without progression and global survival. Usually&#xD;
      administered in the day hospitalization department, its preparation and administration to the&#xD;
      patient are compatible with hospital-at-home management. Currently, this offer of care is&#xD;
      rarely proposed, and only in particular situations. At the Hospital of Pau, it was introduced&#xD;
      recently. It is proposed to patients who have been receiving immunotherapy for at least 4&#xD;
      months. At the moment, there is no study stating the feasibility of home hospitalization for&#xD;
      patients treated by immunotherapy. Given that there is neither regulatory obstacle nor any&#xD;
      contraindication to care in home hospitalization, the choice of a descriptive study stands&#xD;
      out.&#xD;
&#xD;
      This study will be proposed to all the patients for whom home hospitalization has been&#xD;
      decided and scheduled by the healthcare team in a medical staff meeting.&#xD;
&#xD;
      The patients included in the study will be followed according to the common practice: a&#xD;
      consultation every 3 months during 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Actual">December 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)</measure>
    <time_frame>1 year</time_frame>
    <description>Feasibility under good conditions of home-based immunotherapy, defined by the percentage of patients who interrupted their home hospitalization for reasons directly linked to that management.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse effects</measure>
    <time_frame>1 year</time_frame>
    <description>Immunotherapy related adverse effects monitoring criteria evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Incidents occurring during the Hospital at Home program handling process</measure>
    <time_frame>1 year</time_frame>
    <description>The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire (EORTC QLQ-C30) total score</measure>
    <time_frame>at inclusion, month 3, 6 9 and 12</time_frame>
    <description>To study the patient's reported quality of life before and throughout therapy. Quality of life score obtained through self-administered EORCT QLQ-C30 questionnaire at inclusion, month 3, 6 9 and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' Satisfaction Questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12.</description>
  </secondary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Bronchial Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated by immunotherapy for bronchial cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 and over.&#xD;
&#xD;
          -  with bronchial cancer treated with immunotherapy,&#xD;
&#xD;
          -  having two assessments of the response to immunotherapy received in day&#xD;
             hospitalization with efficiency (stability or partial response)&#xD;
&#xD;
          -  without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse&#xD;
             effects related to immunotherapy&#xD;
&#xD;
          -  eligible for a home-based hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient receiving immunotherapy via temporary authorization for use,&#xD;
&#xD;
          -  Frail patients requiring a frequent medical assessment thus day hospitalization cares&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre hospitalier de pau</name>
      <address>
        <city>Pau</city>
        <state>Aquitaine</state>
        <zip>64160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier de PAU</investigator_affiliation>
    <investigator_full_name>RENAULT Patrick Aldo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Immunotherapy, bronchial cancer, home-based hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Bronchogenic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03786653
org study id: CHPAU2018/02
nct id: NCT03786653
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational prospective monosite study aims to describe, for the first time,
      management in a hospital-at-home programme of patients treated by immunotherapy for bronchial
      cancer.

      The feasibility in good conditions of this management, the patients' quality of life and
      their satisfaction will be evaluated.
Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress
      in terms of tumoral answer, survival without progression and global survival. Usually
      administered in the day hospitalization department, its preparation and administration to the
      patient are compatible with hospital-at-home management. Currently, this offer of care is
      rarely proposed, and only in particular situations. At the Hospital of Pau, it was introduced
      recently. It is proposed to patients who have been receiving immunotherapy for at least 4
      months. At the moment, there is no study stating the feasibility of home hospitalization for
      patients treated by immunotherapy. Given that there is neither regulatory obstacle nor any
      contraindication to care in home hospitalization, the choice of a descriptive study stands
      out.

      This study will be proposed to all the patients for whom home hospitalization has been
      decided and scheduled by the healthcare team in a medical staff meeting.

      The patients included in the study will be followed according to the common practice: a
      consultation every 3 months during 1 year.
observational model: Case-Only
time perspective: Prospective
measure: Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)
time frame: 1 year
description: Feasibility under good conditions of home-based immunotherapy, defined by the percentage of patients who interrupted their home hospitalization for reasons directly linked to that management.
measure: adverse effects
time frame: 1 year
description: Immunotherapy related adverse effects monitoring criteria evaluation
measure: Number of Incidents occurring during the Hospital at Home program handling process
time frame: 1 year
description: The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.
measure: Quality of Life Questionnaire (EORTC QLQ-C30) total score
time frame: at inclusion, month 3, 6 9 and 12
description: To study the patient's reported quality of life before and throughout therapy. Quality of life score obtained through self-administered EORCT QLQ-C30 questionnaire at inclusion, month 3, 6 9 and 12.
measure: Patients' Satisfaction Questionnaire
time frame: 1 year
description: Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier de PAU
investigator full name: RENAULT Patrick Aldo
investigator title: Principal Investigator
mesh term: Carcinoma, Bronchogenic