<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/NCT04478903</url>
  </required_header>
  <id_info>
    <org_study_id>QUIPOURT 2019</org_study_id>
    <nct_id>NCT04478903</nct_id>
  </id_info>
  <brief_title>Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management</brief_title>
  <acronym>FARAPPAC</acronym>
  <official_title>Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer is a disease that requires long-term management, especially now that medical advances&#xD;
      have transformed most cancers from an acute to a chronic condition. Most of the time,&#xD;
      therefore, the help provided by family and friends is long-term.&#xD;
&#xD;
      The negative impact of oncological care on the quality of life of family caregivers has&#xD;
      already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of&#xD;
      cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care.&#xD;
      This study showed that several factors were significantly related to the caregiver's quality&#xD;
      of life: the caregiver's age, perception of burden and patient autonomy (18). However, the&#xD;
      evolution of quality of life and burden at 5 years has, to our knowledge, never been&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">November 16, 2020</completion_date>
  <primary_completion_date type="Actual">November 16, 2020</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>To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management.</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Quality of life is measured using the SF-12 (short form) questionnaire. This is an abbreviated version of the Medical Outcomes Study Short-form General Health survey (SF-36).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Quality of Life</condition>
  <condition>Primary Patient Caregiver</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>primary caregiver of patients aged 70 and over</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Zarit Burden Inventory French version and SF12</description>
    <arm_group_label>primary caregiver of patients aged 70 and over</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrieval of information and contact details of primary caregivers included in the 2014&#xD;
        study along with the patient's vital status&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person who does not object to being included in the study&#xD;
&#xD;
          -  Primary caregiver of a cancer patient aged 70 years and over who is managed in one of&#xD;
             the centres participating in the study, with a request for an oncogeriatric&#xD;
             consultation between 01/06/2014 and 18/03/2015.&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Good command of the French language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal or linguistic or psychological inability to answer the questionnaires.&#xD;
&#xD;
          -  Caregiver whose general condition does not allow him/her to answer a questionnaire&#xD;
&#xD;
          -  Death of the caregiver.&#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>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04478903
org study id: QUIPOURT 2019
nct id: NCT04478903
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cancer is a disease that requires long-term management, especially now that medical advances
      have transformed most cancers from an acute to a chronic condition. Most of the time,
      therefore, the help provided by family and friends is long-term.

      The negative impact of oncological care on the quality of life of family caregivers has
      already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of
      cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care.
      This study showed that several factors were significantly related to the caregiver's quality
      of life: the caregiver's age, perception of burden and patient autonomy (18). However, the
      evolution of quality of life and burden at 5 years has, to our knowledge, never been
      evaluated.
observational model: Cohort
time perspective: Prospective
measure: To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management.
time frame: Through study completion, an average of 1 year
description: Quality of life is measured using the SF-12 (short form) questionnaire. This is an abbreviated version of the Medical Outcomes Study Short-form General Health survey (SF-36).
arm group label: primary caregiver of patients aged 70 and over
intervention type: Other
intervention name: Questionnaire
description: Zarit Burden Inventory French version and SF12
arm group label: primary caregiver of patients aged 70 and over
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor