<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/NCT04458740</url>
  </required_header>
  <id_info>
    <org_study_id>MACHROAPICANCERPLUS65</org_study_id>
    <nct_id>NCT04458740</nct_id>
  </id_info>
  <brief_title>The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family</brief_title>
  <acronym>MACHROAPIK65</acronym>
  <official_title>The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family</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>
    <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>
      Given a context where patients autonomy respect is important, it is necessary to pay a&#xD;
      sustained attention to the patients care and life experiences, as well as the families and&#xD;
      relatives of patients with colorectal cancer or patients in remission of colorectal cancer.&#xD;
      Thanks to families and relatives data, it will allow to improve the analyses carried out by&#xD;
      the &quot;Societal Cancer Observatory&quot; in 2016.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</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>Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients after 65 years old with colorectal cancer</measure>
    <time_frame>2 hours</time_frame>
    <description>semi-structured patients interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess how the patients and their family members face the disease</measure>
    <time_frame>1 hour</time_frame>
    <description>semi-structured patients interview</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <description>Patients with a diagnosis of colorectal cancer after 65 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The spouse and /or children and /or parents</arm_group_label>
    <description>The spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biographical interviews</intervention_name>
    <description>A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual</description>
    <arm_group_label>Patient</arm_group_label>
    <arm_group_label>The spouse and /or children and /or parents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surviving patients between 65 and 80 years and diagnosed with invasive CRC, infiltrating&#xD;
        adenocarcinoma of the colon or rectum irrespective of the stage before 65 years old will be&#xD;
        selected in the Poitou-Charentes cancer registry 2 to 5 years after announcement of the&#xD;
        diagnosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The patients will be:&#xD;
&#xD;
          -  over the age of 65 and under 80&#xD;
&#xD;
          -  with a colorectal cancer operated between 65 and 80 years with a documented&#xD;
             histological diagnosis, dating from 2 to 5 years.&#xD;
&#xD;
          -  be able to provide informed consent and appoint a caregiver who would be willing to&#xD;
             participate in the study.&#xD;
&#xD;
        The spouse and / or children and / or parents will be eligible:&#xD;
&#xD;
        if he is at least 18 years old, if he can be considered a caregiver of the index patient&#xD;
        for whom a diagnosis of CRC has been made.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of colorectal cancer before the age of 65 or after the age&#xD;
             of 80 from 2 to 5 years old.&#xD;
&#xD;
        Near a deceased patient or under 18 years old.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Registre du Cancer</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</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>Colorectal Neoplasms</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/NCT04458740
org study id: MACHROAPICANCERPLUS65
nct id: NCT04458740
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Given a context where patients autonomy respect is important, it is necessary to pay a
      sustained attention to the patients care and life experiences, as well as the families and
      relatives of patients with colorectal cancer or patients in remission of colorectal cancer.
      Thanks to families and relatives data, it will allow to improve the analyses carried out by
      the "Societal Cancer Observatory" in 2016.
observational model: Cohort
time perspective: Prospective
measure: Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients after 65 years old with colorectal cancer
time frame: 2 hours
description: semi-structured patients interview
measure: Assess how the patients and their family members face the disease
time frame: 1 hour
description: semi-structured patients interview
arm group label: Patient
description: Patients with a diagnosis of colorectal cancer after 65 years.
arm group label: The spouse and /or children and /or parents
description: The spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years.
intervention type: Other
intervention name: biographical interviews
description: A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual
arm group label: Patient
arm group label: The spouse and /or children and /or parents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
facility: 
country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No