<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/NCT03229343</url>
  </required_header>
  <id_info>
    <org_study_id>P150965</org_study_id>
    <nct_id>NCT03229343</nct_id>
  </id_info>
  <brief_title>Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis.</brief_title>
  <acronym>PALIF</acronym>
  <official_title>Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis (IPF). A Randomized Multi-center Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median&#xD;
      between 2 and 4 years which leads to a profound alteration of the quality of life.&#xD;
&#xD;
      In thoracic oncology, the systematic and early intervention of a palliative care team result&#xD;
      in an improvement of quality of life for patients.&#xD;
&#xD;
      In the princeps study published in 2010, the early intervention of a dedicated palliative&#xD;
      care team was compared to standard care in a randomized trial of 150 patients and shows a&#xD;
      significant improvement : (i) of quality of life (main objective), (ii) of depression scores&#xD;
      and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of&#xD;
      understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted&#xD;
      hospitalization in end of life (in emergency or not).&#xD;
&#xD;
      Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory&#xD;
      symptom, psychological burden), it seemed reasonable to assume that the joint systematic&#xD;
      intervention of chest physician and palliative care team may provide a significant benefit in&#xD;
      terms of quality of life for patients with severe IPF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median&#xD;
      between 2 and 4 years which leads to a profound alteration of the quality of life. This&#xD;
      alteration results from different consequences of the IPF: progressive shortness of breath,&#xD;
      irritative cough refractory to treatments, exhaustion, limitation of activity, social&#xD;
      isolation, and psychic consequences such as fear, anxiety and depression.&#xD;
&#xD;
      The only current curative treatment of the disease is pulmonary transplantation, but it's&#xD;
      only feasible for a minority of patients. Anti-fibrotic drugs, such as pirfenidone and&#xD;
      nintedanib, are likely to slow the progression of IPF but have no impact on patients' quality&#xD;
      of life.&#xD;
&#xD;
      The symptomatic treatment aimed at relieving respiratory discomfort and the patient's quality&#xD;
      of life is therefore fundamental, and the IPF meets in many ways the challenges of lung&#xD;
      cancer.&#xD;
&#xD;
      In thoracic oncology, the systematic and early intervention of a palliative care team result&#xD;
      in an improvement of quality of life for patients.&#xD;
&#xD;
      In the princeps study published in 2010, the early intervention of a dedicated palliative&#xD;
      care team was compared to standard care in a randomized trial of 150 patients and shows a&#xD;
      significant improvement : (i) of quality of life (main objective), (ii) of depression scores&#xD;
      and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of&#xD;
      understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted&#xD;
      hospitalization in end of life (in emergency or not).&#xD;
&#xD;
      Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory&#xD;
      symptom, psychological burden), it seemed reasonable to assume that the joint systematic&#xD;
      intervention of chest physician and palliative care team may provide a significant benefit in&#xD;
      terms of quality of life for patients with severe IPF.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To investigate the benefit on quality of life, evaluated after 6 months, of a systematic,&#xD;
      formalized and joint intervention of a palliative intervention staff and a chest physician&#xD;
      team compared to standard care for patients with severe IPF.&#xD;
&#xD;
      Secondary endpoints&#xD;
&#xD;
        1. To evaluate the benefit of the systematic, formalized and joint intervention of a&#xD;
           palliative care team and a chest physician team on:&#xD;
&#xD;
             -  Mood and depression&#xD;
&#xD;
             -  Understanding of diagnosis and therapeutic objectives, frequency of drafting of&#xD;
                advance directives regarding end-of-life&#xD;
&#xD;
             -  Respiratory symptoms (cough and dyspnea)&#xD;
&#xD;
             -  The course of care, the use of palliative care stays and the duration of hospital&#xD;
                stays (number and duration of hospitalizations).&#xD;
&#xD;
             -  Overall survival and place of death.&#xD;
&#xD;
        2. Carry out a medico-economic study evaluating the incremental cost-utility and&#xD;
           cost-effectiveness ratio (overall survival criterion)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Experimental arm : supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.&#xD;
Non interventionnel arm: only pneumological consultation performed at M0, M3 and M6.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The benefit of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team on quality of life, evaluated after 6 months by the Short Form (36) Health Survey.</measure>
    <time_frame>at 6 months after inclusion</time_frame>
    <description>The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The Short Form (36) Health Survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. This score has already been used for IPF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Mood and depression</measure>
    <time_frame>at 3 and 6 months after inclusion</time_frame>
    <description>evaluated by the Hospital Anxiety and Depression questionnaire.&#xD;
Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives&#xD;
Respiratory symptoms (dyspnea)&#xD;
The course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations).&#xD;
Overall survival and place of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives.</measure>
    <time_frame>at 3 and 6 months after inclusion</time_frame>
    <description>the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives will be evaluated by the illness understanding questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea)</measure>
    <time_frame>at 3 and 6 months after inclusion</time_frame>
    <description>The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea) will be evaluated by St George's respiratory questionnaire (SGRQ) and Transition Dyspnea Index (TDI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care.</measure>
    <time_frame>at 3 and 6 months after inclusion</time_frame>
    <description>the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival.</measure>
    <time_frame>between inclusion and date of death or last news. (survival follow-up visit at month 12)</time_frame>
    <description>the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival measured between inclusion and date of death or last news.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)</measure>
    <time_frame>at 3 and 6 months after inclusion</time_frame>
    <description>This outcome is evaluated by the medico-economic questionnaire : EuroQol five dimensions questionnaire (EQ-5D)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>pneumological consultation performed at M0, M3 and M6</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supportive care</intervention_name>
    <description>supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 40 years&#xD;
&#xD;
          -  Patient with confirmed diagnosis of IPF according to the American Thoracic Society&#xD;
             (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) /&#xD;
             Latin American Thoracic Association (ALAT) criteria. The patient may be included&#xD;
             regardless of the date of diagnosis.&#xD;
&#xD;
          -  Advanced IPF with Forced Vital Capacity (FVC) &lt;50%&quot; of predicted value and / or&#xD;
             Diffusing capacity for carbon monoxide ((DLCO) &lt;30% of predicted value or inability to&#xD;
             achieve the Functional Respiratory Investigations (EFR) due to respiratory severity.&#xD;
             EFR dated less than 3 months.&#xD;
&#xD;
          -  Absence of argument for acute or subacute exacerbation in the last 6 months.&#xD;
&#xD;
          -  Patient who can be followed in ambulatory consultation/ outpatient consultation.&#xD;
&#xD;
          -  Informed consent signed (signed by the patient or in the presence of a third party for&#xD;
             patients who are poorly fluent in French).&#xD;
&#xD;
          -  Affiliation to the social security system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to respond to quality of life questionnaires.&#xD;
&#xD;
          -  Inability (physical or mental) to give a written informed consent.&#xD;
&#xD;
          -  Acute exacerbation of fibrosis in the previous 6 months.&#xD;
&#xD;
          -  Patient eligible for a pulmonary transplant.&#xD;
&#xD;
          -  Participation in other therapeutic trial&#xD;
&#xD;
          -  Patient cannot be followed in ambulatory consultation.&#xD;
&#xD;
          -  Patient under trustee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris Duchemann</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Boris Duchemann, Dr</last_name>
    <phone>01 48 95 50 32</phone>
    <email>boris.duchemann@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nacira DARGHAL, PhD</last_name>
    <phone>01 48 95 74 73</phone>
    <email>nacira.darghal@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Robert Ballanger</name>
      <address>
        <city>Aulnay-sous-Bois</city>
        <zip>93602</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jérome VIRALLY, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boris DUCHEMANN, PI</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles Andre Mignot</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nathalie MICHENOT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital LOUIS PRADEL</name>
      <address>
        <city>Lyon</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vicent COTTIN, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital NORD</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Martine REYNAUD GAUBERT, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital MARC JACQUET</name>
      <address>
        <city>Melun</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djamel BENNEGADI, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital GEORGES POMPIDOU (HEGP)</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dominique ISRAEL-BIET, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean Marc NACCACHE, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane JOUNEAU, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital DELAFONTAINE</name>
      <address>
        <city>Saint-Denis</city>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Isabelle LERAT, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital LARREY</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Grégoire PREVOT, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Swigris JJ, Brown KK, Behr J, du Bois RM, King TE, Raghu G, Wamboldt FS. The SF-36 and SGRQ: validity and first look at minimum important differences in IPF. Respir Med. 2010 Feb;104(2):296-304. doi: 10.1016/j.rmed.2009.09.006. Epub 2009 Oct 7.</citation>
    <PMID>19815403</PMID>
  </reference>
  <reference>
    <citation>Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax. 2005 Jul;60(7):588-94. doi: 10.1136/thx.2004.035220.</citation>
    <PMID>15994268</PMID>
  </reference>
  <reference>
    <citation>Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.</citation>
    <PMID>20818875</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 4, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>idiopathic pulmonary fibrosis, palliative care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT03229343
org study id: P150965
nct id: NCT03229343
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median
      between 2 and 4 years which leads to a profound alteration of the quality of life.

      In thoracic oncology, the systematic and early intervention of a palliative care team result
      in an improvement of quality of life for patients.

      In the princeps study published in 2010, the early intervention of a dedicated palliative
      care team was compared to standard care in a randomized trial of 150 patients and shows a
      significant improvement : (i) of quality of life (main objective), (ii) of depression scores
      and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of
      understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted
      hospitalization in end of life (in emergency or not).

      Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory
      symptom, psychological burden), it seemed reasonable to assume that the joint systematic
      intervention of chest physician and palliative care team may provide a significant benefit in
      terms of quality of life for patients with severe IPF.
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median
      between 2 and 4 years which leads to a profound alteration of the quality of life. This
      alteration results from different consequences of the IPF: progressive shortness of breath,
      irritative cough refractory to treatments, exhaustion, limitation of activity, social
      isolation, and psychic consequences such as fear, anxiety and depression.

      The only current curative treatment of the disease is pulmonary transplantation, but it's
      only feasible for a minority of patients. Anti-fibrotic drugs, such as pirfenidone and
      nintedanib, are likely to slow the progression of IPF but have no impact on patients' quality
      of life.

      The symptomatic treatment aimed at relieving respiratory discomfort and the patient's quality
      of life is therefore fundamental, and the IPF meets in many ways the challenges of lung
      cancer.

      In thoracic oncology, the systematic and early intervention of a palliative care team result
      in an improvement of quality of life for patients.

      In the princeps study published in 2010, the early intervention of a dedicated palliative
      care team was compared to standard care in a randomized trial of 150 patients and shows a
      significant improvement : (i) of quality of life (main objective), (ii) of depression scores
      and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of
      understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted
      hospitalization in end of life (in emergency or not).

      Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory
      symptom, psychological burden), it seemed reasonable to assume that the joint systematic
      intervention of chest physician and palliative care team may provide a significant benefit in
      terms of quality of life for patients with severe IPF.

      Objective:

      To investigate the benefit on quality of life, evaluated after 6 months, of a systematic,
      formalized and joint intervention of a palliative intervention staff and a chest physician
      team compared to standard care for patients with severe IPF.

      Secondary endpoints

        1. To evaluate the benefit of the systematic, formalized and joint intervention of a
           palliative care team and a chest physician team on:

             -  Mood and depression

             -  Understanding of diagnosis and therapeutic objectives, frequency of drafting of
                advance directives regarding end-of-life

             -  Respiratory symptoms (cough and dyspnea)

             -  The course of care, the use of palliative care stays and the duration of hospital
                stays (number and duration of hospitalizations).

             -  Overall survival and place of death.

        2. Carry out a medico-economic study evaluating the incremental cost-utility and
           cost-effectiveness ratio (overall survival criterion)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental arm : supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
Non interventionnel arm: only pneumological consultation performed at M0, M3 and M6.
primary purpose: Supportive Care
masking: None (Open Label)
measure: The benefit of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team on quality of life, evaluated after 6 months by the Short Form (36) Health Survey.
time frame: at 6 months after inclusion
description: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The Short Form (36) Health Survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. This score has already been used for IPF
measure: The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Mood and depression
time frame: at 3 and 6 months after inclusion
description: evaluated by the Hospital Anxiety and Depression questionnaire.
Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives
Respiratory symptoms (dyspnea)
The course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations).
Overall survival and place of death.
measure: The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives.
time frame: at 3 and 6 months after inclusion
description: the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives will be evaluated by the illness understanding questionnaire.
measure: The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea)
time frame: at 3 and 6 months after inclusion
description: The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on Respiratory symptoms (dyspnea) will be evaluated by St George's respiratory questionnaire (SGRQ) and Transition Dyspnea Index (TDI)
measure: The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care.
time frame: at 3 and 6 months after inclusion
description: the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations)
measure: The benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival.
time frame: between inclusion and date of death or last news. (survival follow-up visit at month 12)
description: the benefit of the systematic, formalized and joint intervention of a supportive care and a pneumologist team on the Overall survival measured between inclusion and date of death or last news.
measure: Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)
time frame: at 3 and 6 months after inclusion
description: This outcome is evaluated by the medico-economic questionnaire : EuroQol five dimensions questionnaire (EQ-5D)
arm group label: Experimental
arm group type: Experimental
description: Supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
arm group label: standard
arm group type: No Intervention
description: pneumological consultation performed at M0, M3 and M6
intervention type: Other
intervention name: Supportive care
description: supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
arm group label: Experimental
criteria: 
gender: All
minimum age: 41 Years
maximum age: N/A
healthy volunteers: No
last name: Boris Duchemann
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Boris Duchemann, Dr
phone: 01 48 95 50 32
email: boris.duchemann@aphp.fr
last name: Nacira DARGHAL, PhD
phone: 01 48 95 74 73
email: nacira.darghal@aphp.fr
facility: 
status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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country: France
citation: Swigris JJ, Brown KK, Behr J, du Bois RM, King TE, Raghu G, Wamboldt FS. The SF-36 and SGRQ: validity and first look at minimum important differences in IPF. Respir Med. 2010 Feb;104(2):296-304. doi: 10.1016/j.rmed.2009.09.006. Epub 2009 Oct 7.
PMID: 19815403
citation: Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax. 2005 Jul;60(7):588-94. doi: 10.1136/thx.2004.035220.
PMID: 15994268
citation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PMID: 20818875
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
sharing ipd: No