xml: <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/NCT06025604</url>
    </required_header>
    <id_info>
      <org_study_id>38RC23.0151</org_study_id>
      <secondary_id>2023-A01036-39</secondary_id>
      <nct_id>NCT06025604</nct_id>
    </id_info>
    <brief_title>ACTIVPROSEIN : Professional Activity After Breast Cancer</brief_title>
    <official_title>Psycho Social Factors Associated to Return to Work After Breast Cancer Care : a Prognostic Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Grenoble</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Grenoble</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>
        Breast cancer is, in term of incidence, the first cancer among women in France and worldwide.&#xD;
        This incidence is increasing, particularly among young women during their professional&#xD;
        activity.&#xD;
  &#xD;
        Those observations raise de question of return to work of those patients, and, broadly, of&#xD;
        the post cancer life and former activities recovery.&#xD;
  &#xD;
        The objective of the study is to identify any factor influencing time from diagnosis to&#xD;
        return to work (type of treatment, side effects, residual symptoms, medical staff support,&#xD;
        occupational physician monitoring, individual or group supportive therapy, adapted physical&#xD;
        activity, alternative therapeutics ..), and the main modalities of return to work (part or&#xD;
        full time, professional redeployment).&#xD;
  &#xD;
        To identify those factors, barriers or supports, would enable the implementation of concrete&#xD;
        actions and programs, promoting return to work, and to a free disease life for those&#xD;
        patients.&#xD;
  &#xD;
        The main objective is to identify psycho social factors involved in the time from diagnosis&#xD;
        to return to any modality of work, until 24 month after localized breast cancer care, in&#xD;
        Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to&#xD;
        identify psycho social factors involved in the time from diagnosis to return to work, part&#xD;
        time, full time, and redeployment, respectively, until 24 month after localized breast cancer&#xD;
        care, in Grenoble University Hospital (Michalon and Voiron included)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients being took care in Grenoble University Hospital, including Voiron site, from 2015 to&#xD;
        2019, for a localized breast cancer, will be identified be Cristal Link software.&#xD;
  &#xD;
        A questionary, including every studied variables and potential confounding factors, will be&#xD;
        sent, by post or by e mail, to the patients. An information notice and a non opposition&#xD;
        formulary will be joined to the questionary.&#xD;
  &#xD;
        Patients will be contacted by a paramedical member of the Women Cancer Center of the&#xD;
        University Hospital, in order to explain them the objective of the study, and the modality of&#xD;
        personal data management.&#xD;
  &#xD;
        The questionary will be returned either by mail, or directly brought back to the Hospital&#xD;
        along a medical appointment.&#xD;
  &#xD;
        Data collection will focus on return to work delay, return to work modality (part or full&#xD;
        time, redeployment), studied variables and potential confounding factors (demographic :&#xD;
        marital status, number of dependent children, incomes / related to occupational activity :&#xD;
        night work, job responsibility, occupational physician follow up / treatment consequences :&#xD;
        OMS status, anxiety, depression, lymphoedema, articular pain, neuropathic pain / Support&#xD;
        measures : physical activities, psychological support, alternative therapeutics, familial&#xD;
        support, medical staff support).&#xD;
  &#xD;
        Medical data (tumour features : histology, extent, treatment : surgery, chemiotherapy,&#xD;
        targeted therapy, hormonotherapy, radiotherapy) will be collected using informatic files.&#xD;
  &#xD;
        Subjective variables will be evaluated using standardized questionary (Anxiety : Stait Trait&#xD;
        Anxiety Inventory / Depression : Hamilton Depression Scale / Cognition : FACT cog questionary&#xD;
        / Support : Multidimensional Scale of Support).&#xD;
  &#xD;
        Data process will be done in the Clinical Investigation Center of Grenoble University&#xD;
        Hospital.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 14, 2023</start_date>
    <completion_date type="Anticipated">September 13, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 13, 2025</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)</measure>
      <time_frame>30 minutes</time_frame>
      <description>Assessment of delay of a any occupational activity recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To identify the impact of psycho social factors on delay of return to full time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)</measure>
      <time_frame>30 minutes</time_frame>
      <description>Assessment of delay of full time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To identify the impact of psycho social factors on delay of return to part time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)</measure>
      <time_frame>30 minutes</time_frame>
      <description>Assessment of delay of part time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To identify the impact of psycho social factors on delay of return to occupational reclassification, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)</measure>
      <time_frame>30 minutes</time_frame>
      <description>Assessment of delay of occupational reclassification, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables</description>
    </secondary_outcome>
    <enrollment type="Anticipated">578</enrollment>
    <condition>Breast Cancer Female</condition>
    <condition>Return to Work</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Women between 18 and 60 years old, care in Grenoble University Hospital between 2015 and&#xD;
          2019 for a localized breast cancer, working at the time of diagnosis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient between 18 and 60 years old&#xD;
  &#xD;
            -  Histologically proven localized breast cancer, of any subtype&#xD;
  &#xD;
            -  Cared in Grenoble University Hospital between 2015 and 2019&#xD;
  &#xD;
            -  Working at the time of diagnosis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Retired at the end of adjuvant therapy&#xD;
  &#xD;
            -  Deprived of liberty, under juridical protection, not able to give consent&#xD;
  &#xD;
            -  Psychiatric conditions or addictive behavior interfering with questionary filling&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CHU Grenoble Alpes</name>
        <address>
          <city>Grenoble</city>
          <zip>38043</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emmanuelle GA JACQUET</last_name>
        <phone>+33476765451</phone>
        <email>ejacquet1@chu-grenoble.fr</email>
      </contact>
      <contact_backup>
        <last_name>Anne Stoeckle</last_name>
        <email>AStoeckle@chu-grenoble.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Emmanuelle JACQUET</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Observational study</keyword>
    <keyword>Prognostic factors</keyword>
    <keyword>Questionary</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>
  
  
text: 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/NCT06025604
  org study id: 38RC23.0151
  secondary id: 2023-A01036-39
  nct id: NCT06025604
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer is, in term of incidence, the first cancer among women in France and worldwide.
        This incidence is increasing, particularly among young women during their professional
        activity.
  
        Those observations raise de question of return to work of those patients, and, broadly, of
        the post cancer life and former activities recovery.
  
        The objective of the study is to identify any factor influencing time from diagnosis to
        return to work (type of treatment, side effects, residual symptoms, medical staff support,
        occupational physician monitoring, individual or group supportive therapy, adapted physical
        activity, alternative therapeutics ..), and the main modalities of return to work (part or
        full time, professional redeployment).
  
        To identify those factors, barriers or supports, would enable the implementation of concrete
        actions and programs, promoting return to work, and to a free disease life for those
        patients.
  
        The main objective is to identify psycho social factors involved in the time from diagnosis
        to return to any modality of work, until 24 month after localized breast cancer care, in
        Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to
        identify psycho social factors involved in the time from diagnosis to return to work, part
        time, full time, and redeployment, respectively, until 24 month after localized breast cancer
        care, in Grenoble University Hospital (Michalon and Voiron included)
  Patients being took care in Grenoble University Hospital, including Voiron site, from 2015 to
        2019, for a localized breast cancer, will be identified be Cristal Link software.
  
        A questionary, including every studied variables and potential confounding factors, will be
        sent, by post or by e mail, to the patients. An information notice and a non opposition
        formulary will be joined to the questionary.
  
        Patients will be contacted by a paramedical member of the Women Cancer Center of the
        University Hospital, in order to explain them the objective of the study, and the modality of
        personal data management.
  
        The questionary will be returned either by mail, or directly brought back to the Hospital
        along a medical appointment.
  
        Data collection will focus on return to work delay, return to work modality (part or full
        time, redeployment), studied variables and potential confounding factors (demographic :
        marital status, number of dependent children, incomes / related to occupational activity :
        night work, job responsibility, occupational physician follow up / treatment consequences :
        OMS status, anxiety, depression, lymphoedema, articular pain, neuropathic pain / Support
        measures : physical activities, psychological support, alternative therapeutics, familial
        support, medical staff support).
  
        Medical data (tumour features : histology, extent, treatment : surgery, chemiotherapy,
        targeted therapy, hormonotherapy, radiotherapy) will be collected using informatic files.
  
        Subjective variables will be evaluated using standardized questionary (Anxiety : Stait Trait
        Anxiety Inventory / Depression : Hamilton Depression Scale / Cognition : FACT cog questionary
        / Support : Multidimensional Scale of Support).
  
        Data process will be done in the Clinical Investigation Center of Grenoble University
        Hospital.
  observational model: Cohort
  time perspective: Retrospective
  measure: To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
  time frame: 30 minutes
  description: Assessment of delay of a any occupational activity recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
  measure: To identify the impact of psycho social factors on delay of return to full time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
  time frame: 30 minutes
  description: Assessment of delay of full time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
  measure: To identify the impact of psycho social factors on delay of return to part time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
  time frame: 30 minutes
  description: Assessment of delay of part time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
  measure: To identify the impact of psycho social factors on delay of return to occupational reclassification, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
  time frame: 30 minutes
  description: Assessment of delay of occupational reclassification, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Breast Neoplasms