<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/NCT03261128</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A02188-45</org_study_id>
    <nct_id>NCT03261128</nct_id>
  </id_info>
  <brief_title>Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment.(D-FOG)</brief_title>
  <acronym>D-FOG</acronym>
  <official_title>Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment. Feasibility and Acceptability Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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>
      Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence&#xD;
      of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a&#xD;
      self-administered questionnaire carried out by the patient before each chemotherapy cure. The&#xD;
      objective is to secure the quality of patient care and to detect the appearance and / or&#xD;
      aggravation of geriatric fragilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients&#xD;
      aged ≥ 75 years during oncological treatment:&#xD;
&#xD;
        -  Number of D-FOGs filled in: comparison with the number of patients included in the study&#xD;
           and the number of visits of each patient.&#xD;
&#xD;
        -  Regularity of the D-FOG self-questionnaire by the patient: comparison with the number of&#xD;
           visits of the patient for a chemotherapy cure (HDJ or HDS).&#xD;
&#xD;
        -  Number of criteria entered by D-FOG: comparison with the total number of criteria to be&#xD;
           filled in&#xD;
&#xD;
        -  Criterion analysis of D-FOG&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Actual">December 5, 2018</completion_date>
  <primary_completion_date type="Actual">September 11, 2018</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>Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment.</measure>
    <time_frame>3 months</time_frame>
    <description>Feasibility of D-FOG for patients : number of D-FOGs filled in, regularity of the D-FOG self-questionnaire by the patient, number of criteria entered by D-FOG, criterion analysis of D-FOG</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>75 Years Old and More</condition>
  <condition>Cancer</condition>
  <condition>Chemotherapy</condition>
  <arm_group>
    <arm_group_label>Group D-FOG</arm_group_label>
    <description>Filling of a self-questionnaire before each chemotherapy cure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-questionnaire</intervention_name>
    <description>Filling of a self-questionnaire before each chemotherapy cure</description>
    <arm_group_label>Group D-FOG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 75 years and over Cancer and treated with chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 75 years and over&#xD;
&#xD;
          -  Carriers of diagnosed cancer (excluding hematology)&#xD;
&#xD;
          -  Whatever the location, uniqueness or multiple, duration of development and treatment&#xD;
             status (adjuvant, neoadjuvant, locally advanced or metastatic)&#xD;
&#xD;
          -  Seen in nursing consultant&#xD;
&#xD;
          -  Beginning an oncological treatment&#xD;
&#xD;
          -  Supported for oncology day hospital (HDJ) or weekly (HDS) chemotherapy&#xD;
&#xD;
          -  Patient not opposed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 75 years of age&#xD;
&#xD;
          -  Having not had an IDE ad consultation&#xD;
&#xD;
          -  During oncological treatment&#xD;
&#xD;
          -  Receiving Oral Therapy or hormone therapy alone&#xD;
&#xD;
          -  Treated by radiotherapy alone or surgery alone&#xD;
&#xD;
          -  Not attending a day or week oncology hospital&#xD;
&#xD;
          -  Refusal to participate in research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>VALERO SV SIMON, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Poitiers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>chemotherapy</keyword>
  <!-- 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/NCT03261128
org study id: 2017-A02188-45
nct id: NCT03261128
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence
      of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a
      self-administered questionnaire carried out by the patient before each chemotherapy cure. The
      objective is to secure the quality of patient care and to detect the appearance and / or
      aggravation of geriatric fragilities.
Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients
      aged ≥ 75 years during oncological treatment:

        -  Number of D-FOGs filled in: comparison with the number of patients included in the study
           and the number of visits of each patient.

        -  Regularity of the D-FOG self-questionnaire by the patient: comparison with the number of
           visits of the patient for a chemotherapy cure (HDJ or HDS).

        -  Number of criteria entered by D-FOG: comparison with the total number of criteria to be
           filled in

        -  Criterion analysis of D-FOG
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment.
time frame: 3 months
description: Feasibility of D-FOG for patients : number of D-FOGs filled in, regularity of the D-FOG self-questionnaire by the patient, number of criteria entered by D-FOG, criterion analysis of D-FOG
arm group label: Group D-FOG
description: Filling of a self-questionnaire before each chemotherapy cure
intervention type: Other
intervention name: Self-questionnaire
description: Filling of a self-questionnaire before each chemotherapy cure
arm group label: Group D-FOG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: VALERO SV SIMON, Doctor
role: Principal Investigator
affiliation: CHU Poitiers
facility: 
country: France
responsible party type: Sponsor