<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/NCT04469205</url>
  </required_header>
  <id_info>
    <org_study_id>IC 2017-06</org_study_id>
    <nct_id>NCT04469205</nct_id>
  </id_info>
  <brief_title>Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer</brief_title>
  <acronym>OPTICOACH</acronym>
  <official_title>Randomized and Prospective Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Curie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Curie</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>
      Evaluate the impact of coaching sessions on the return to work rate (number of patients&#xD;
      returning at work / total number of patients per arm) 6 months after inclusion in the study&#xD;
      for breast cancer in professionnally active patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">April 5, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 5, 2023</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study</measure>
    <time_frame>6 months</time_frame>
    <description>The rate of patients returning to work (part-time or full-time) for more than 2 weeks to 6 months of inclusion in the study in each group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of the return to work</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Evaluation of the quality of the return to work at 6 and 12 months after inclusion by questionnaire VOW / QFT (in case of return to work only).&#xD;
Evaluation scale : 1=never to 4=ever</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustainability of the return to work</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Evaluation of the durability of the return to work at 6 and 12 months after inclusion by registration by the patients of the number of days off work and / or working time arrangement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the return to work / work stoppage on the quality of life</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Evaluation of the impact of return to work / work stoppage on the quality of life estimated by QLQ-C30 questionnaire at baseline and at 6 and 12 months post-inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The production losses related to presenteeism during maintenance or return to work</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Evaluation of production losses related to presenteeism at the time of maintenance or return to work at 6 and 12 months post inclusion, by collecting the number of days worked during the study period (12 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The production losses related to presenteeism during maintenance or return to work</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Evaluation of the loss of productivity during a professional activity : in case of return to work, the &quot;Work limitation questionnaire&quot; will be completed at 6 and 12 months after inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The determinants of return to work (factors associated with a return to work &quot;successful&quot;: early, sustainable and quality)</measure>
    <time_frame>12 months</time_frame>
    <description>Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-BR23questionnaire.&#xD;
Evaluation scale : 0=not at all to 4=a lot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The determinants of return to work (factors associated with a return to work &quot;successful&quot;: early, sustainable and quality)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-FA12 questionnaire.&#xD;
Evaluation scale : 0=not at all to 4=a lot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The determinants of return to work (factors associated with a return to work &quot;successful&quot;: early, sustainable and quality)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Determining the determinants of return to work at 6 and 12 months post inclusion using the HADS questionnaire.&#xD;
Anxiety scale : 3=most of the time to 0=never Depression scale : 3=never to 0= most of the time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The determinants of return to work (factors associated with a return to work &quot;successful&quot;: early, sustainable and quality)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Determining the determinants of return to work at 6 and 12 months post inclusion using the SSQ6 questionnaire.&#xD;
Evaluation scale : 1=really dissatisfied to 6 =really satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The determinants of return to work (factors associated with a return to work &quot;successful&quot;: early, sustainable and quality)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Determining the determinants of return to work at 6 and 12 months post inclusion using the Brief Cope questionnaire.&#xD;
Evaluation scale : 0=not at all to 4=absolutely</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The determinants of return to work (factors associated with a return to work &quot;successful&quot;: early, sustainable and quality)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>These determinants will also be evaluated through the collection of socio-demographic data, cancer characteristics and treatments administered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The medico-economic impact of returning to work</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation of the medico-economic impact of return to work by comparing the costs of care in the two groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention group that will receive return-to-work coaching sessions. The intervention consists of 3 individual coaching sessions with a certified professional coach. This personalized accompaniment will complete the standard accompaniment offered to all patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group who will receive the current care which consists of a psychosocial care.&#xD;
This care consists in offering the patient regular information meetings organized with social workers of the Health Insurance, to consult a psychologist and to access patients' homes at the frequency of their choice and according to their need.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Coaching sessions</intervention_name>
    <description>There are 3 sessions : the first session will last 1h30 and will be in consultation within the Institut Curie. The second session will last 1h30 and will be done remotely (by phone or by videoconference). The duration of the 3rd and last session will be adapted according to the needs of each patient and will last a maximum of 1 hour. It will also be done remotely (by phone or by videoconference).</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Any patient active at the time of the diagnosis of breast cancer, treated consecutively at&#xD;
        the Institut Curie during the study period, and whose first treatment will be surgery, will&#xD;
        be offered participation in the study.&#xD;
&#xD;
          1. Invasive non-metastatic breast cancer, treated first by surgery&#xD;
&#xD;
          2. Age ≥ 18 and ≤ 60 years&#xD;
&#xD;
          3. Active woman at the time of diagnosis&#xD;
&#xD;
          4. Patient with internet access and email address&#xD;
&#xD;
          5. Patient affiliated with a social security scheme, speaking and reading French&#xD;
&#xD;
          6. Signature of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In situ breast cancer&#xD;
&#xD;
          2. History of breast cancer&#xD;
&#xD;
          3. Metastatic breast cancer&#xD;
&#xD;
          4. Inflammatory Breast Cancer&#xD;
&#xD;
          5. Woman with a life expectancy &lt;6 months at the time of diagnosis (in relation to other&#xD;
             serious chronic diseases)&#xD;
&#xD;
          6. Persons deprived of liberty or under guardianship&#xD;
&#xD;
          7. Impossibility to submit to the medical follow-up of the test for geographical, social&#xD;
             or psychological reasons&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Enora LAAS-FARON, MD</last_name>
    <phone>+33 1 56 24 62 36</phone>
    <email>enora.laas@curie.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne-Sophie PLISSONNIER</last_name>
    <phone>+33 1 47 11 23 78</phone>
    <email>anne-sophie.plissonnier@curie.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Enora LAAS-FARON, MD</last_name>
    </contact>
    <investigator>
      <last_name>Enora LAAS-FARON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire BONNEAU, MD</last_name>
      <email>claire.bonneau@curie.fr</email>
    </contact>
    <investigator>
      <last_name>Claire BONNEAU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</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>Breast 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/NCT04469205
org study id: IC 2017-06
nct id: NCT04469205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluate the impact of coaching sessions on the return to work rate (number of patients
      returning at work / total number of patients per arm) 6 months after inclusion in the study
      for breast cancer in professionnally active patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study
time frame: 6 months
description: The rate of patients returning to work (part-time or full-time) for more than 2 weeks to 6 months of inclusion in the study in each group.
measure: Quality of the return to work
time frame: 6 and 12 months
description: Evaluation of the quality of the return to work at 6 and 12 months after inclusion by questionnaire VOW / QFT (in case of return to work only).
Evaluation scale : 1=never to 4=ever
measure: Sustainability of the return to work
time frame: 6 and 12 months
description: Evaluation of the durability of the return to work at 6 and 12 months after inclusion by registration by the patients of the number of days off work and / or working time arrangement
measure: Impact of the return to work / work stoppage on the quality of life
time frame: 6 and 12 months
description: Evaluation of the impact of return to work / work stoppage on the quality of life estimated by QLQ-C30 questionnaire at baseline and at 6 and 12 months post-inclusion
measure: The production losses related to presenteeism during maintenance or return to work
time frame: 6 and 12 months
description: Evaluation of production losses related to presenteeism at the time of maintenance or return to work at 6 and 12 months post inclusion, by collecting the number of days worked during the study period (12 months)
measure: The production losses related to presenteeism during maintenance or return to work
time frame: 6 and 12 months
description: Evaluation of the loss of productivity during a professional activity : in case of return to work, the "Work limitation questionnaire" will be completed at 6 and 12 months after inclusion
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
time frame: 12 months
description: Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-BR23questionnaire.
Evaluation scale : 0=not at all to 4=a lot
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
time frame: 6 and 12 months
description: Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-FA12 questionnaire.
Evaluation scale : 0=not at all to 4=a lot
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
time frame: 6 and 12 months
description: Determining the determinants of return to work at 6 and 12 months post inclusion using the HADS questionnaire.
Anxiety scale : 3=most of the time to 0=never Depression scale : 3=never to 0= most of the time
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
time frame: 6 and 12 months
description: Determining the determinants of return to work at 6 and 12 months post inclusion using the SSQ6 questionnaire.
Evaluation scale : 1=really dissatisfied to 6 =really satisfied
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
time frame: 6 and 12 months
description: Determining the determinants of return to work at 6 and 12 months post inclusion using the Brief Cope questionnaire.
Evaluation scale : 0=not at all to 4=absolutely
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
time frame: 6 and 12 months
description: These determinants will also be evaluated through the collection of socio-demographic data, cancer characteristics and treatments administered.
measure: The medico-economic impact of returning to work
time frame: 12 months
description: Evaluation of the medico-economic impact of return to work by comparing the costs of care in the two groups
arm group label: Intervention Group
arm group type: Experimental
description: intervention group that will receive return-to-work coaching sessions. The intervention consists of 3 individual coaching sessions with a certified professional coach. This personalized accompaniment will complete the standard accompaniment offered to all patients.
arm group label: Control Group
arm group type: No Intervention
description: control group who will receive the current care which consists of a psychosocial care.
This care consists in offering the patient regular information meetings organized with social workers of the Health Insurance, to consult a psychologist and to access patients' homes at the frequency of their choice and according to their need.
intervention type: Other
intervention name: Coaching sessions
description: There are 3 sessions : the first session will last 1h30 and will be in consultation within the Institut Curie. The second session will last 1h30 and will be done remotely (by phone or by videoconference). The duration of the 3rd and last session will be adapted according to the needs of each patient and will last a maximum of 1 hour. It will also be done remotely (by phone or by videoconference).
arm group label: Intervention Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Enora LAAS-FARON, MD
phone: +33 1 56 24 62 36
email: enora.laas@curie.fr
last name: Anne-Sophie PLISSONNIER
phone: +33 1 47 11 23 78
email: anne-sophie.plissonnier@curie.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No