<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/NCT01661816</url>
  </required_header>
  <id_info>
    <org_study_id>KALICOU</org_study_id>
    <nct_id>NCT01661816</nct_id>
  </id_info>
  <brief_title>Breast Cancer and Quality of Life</brief_title>
  <acronym>KALICOU</acronym>
  <official_title>Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Oscar Lambret</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Oscar Lambret</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to analyse and decode interviews of patient with breast cancer, and then&#xD;
      established according a multidimensional profile specific to the population and to create a&#xD;
      questionnaire tha will allow a practical and qualitative evaluation of the quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2007</start_date>
  <completion_date type="Actual">June 2008</completion_date>
  <primary_completion_date type="Actual">June 2008</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>quality of life at different time of medical follow up</measure>
    <time_frame>6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis</time_frame>
    <description>interviews with couples at different time frame depending on which group they are in</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">171</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Within chemotherapy</arm_group_label>
    <description>30 couples, interviewed within chemotherapy (6 to 8 months after diagnosis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>within Herceptin</arm_group_label>
    <description>30 couples, within herceptin treatment (the first year after diagnosis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>within hormonotherapy</arm_group_label>
    <description>30 couples, within hormonotherapy (between 2 and 7 years after diagnosis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without hormonotherapy</arm_group_label>
    <description>30 couples, did not received hormonotherapy (1 year after diagnosis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>end of treatment</arm_group_label>
    <description>30 couples, after end of treatments for patients who did received hormonotherapy (7 years after diagnosis)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>interview</intervention_name>
    <description>psychological, emotional, family and social parameters</description>
    <arm_group_label>Within chemotherapy</arm_group_label>
    <arm_group_label>end of treatment</arm_group_label>
    <arm_group_label>within Herceptin</arm_group_label>
    <arm_group_label>within hormonotherapy</arm_group_label>
    <arm_group_label>without hormonotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient with breast cancer, diagnosed before aged 45, having a life partner&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &lt; 45&#xD;
&#xD;
          -  non metastatic breast cancer&#xD;
&#xD;
          -  at least 6 months of relationship&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no life partner&#xD;
&#xD;
          -  inclusion criteria failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>François Baclesse Center</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oscar Lambret Center</name>
      <address>
        <city>Lille</city>
        <zip>59 020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy Institut</name>
      <address>
        <city>Paris</city>
        <zip>75 005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>everyday issues</keyword>
  <keyword>couple</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT01661816
org study id: KALICOU
nct id: NCT01661816
lead sponsor: 
has dmc: No
The study aims to analyse and decode interviews of patient with breast cancer, and then
      established according a multidimensional profile specific to the population and to create a
      questionnaire tha will allow a practical and qualitative evaluation of the quality of life.
observational model: Cohort
time perspective: Prospective
measure: quality of life at different time of medical follow up
time frame: 6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis
description: interviews with couples at different time frame depending on which group they are in
arm group label: Within chemotherapy
description: 30 couples, interviewed within chemotherapy (6 to 8 months after diagnosis)
arm group label: within Herceptin
description: 30 couples, within herceptin treatment (the first year after diagnosis)
arm group label: within hormonotherapy
description: 30 couples, within hormonotherapy (between 2 and 7 years after diagnosis)
arm group label: without hormonotherapy
description: 30 couples, did not received hormonotherapy (1 year after diagnosis)
arm group label: end of treatment
description: 30 couples, after end of treatments for patients who did received hormonotherapy (7 years after diagnosis)
intervention type: Behavioral
intervention name: interview
description: psychological, emotional, family and social parameters
arm group label: Within chemotherapy
arm group label: end of treatment
arm group label: within Herceptin
arm group label: within hormonotherapy
arm group label: without hormonotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms