<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/NCT03302767</url>
  </required_header>
  <id_info>
    <org_study_id>IB2017-03</org_study_id>
    <secondary_id>2017-A01251-52</secondary_id>
    <nct_id>NCT03302767</nct_id>
  </id_info>
  <brief_title>CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology</brief_title>
  <acronym>CAP'ONCO</acronym>
  <official_title>CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Bergonié</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Bergonié</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>
      This patient support system is designed to help patients regain their professional activity&#xD;
      after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:&#xD;
&#xD;
        -  A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist /&#xD;
           Neuropsychologist)&#xD;
&#xD;
        -  Monthly information meetings and workshops (TIC'Onco reunions: collective information&#xD;
           times and Cogit'Onco workshops: cognitive workshops&#xD;
&#xD;
        -  An information booklet &quot;Prepare the work return&quot; The aim of this research is to evaluate&#xD;
           efficiency in term of quality of life improvement linked to work status, utility,&#xD;
           feasibility and patients' satisfaction.&#xD;
&#xD;
      The aim of this research is to evaluate efficiency in term of quality of life improvement&#xD;
      linked to work status, utility, feasibility and patients' satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unmet need characterize in 4 points:&#xD;
&#xD;
        -  Cancer and survival: challenges for cancer patients who want to work while being treated&#xD;
&#xD;
        -  Cancer and career: Job instability for cancer patients&#xD;
&#xD;
        -  Difficulties and isolation of patients due to a lack of coordination between healthcare&#xD;
           professionals and colleagues/management&#xD;
&#xD;
        -  Post-treatment cognitive troubles stress and hindered patient return to employment:&#xD;
           chemo brain This research-action will propose and evaluate a concrete device: To&#xD;
           maintain a professional activity with the support of CAP'Onco during treatment, to&#xD;
           balance between quality of life, managing the &quot;cancer event&quot; and the psychosocial&#xD;
           consequences for professional experience, to provide an early, durable and multimodal&#xD;
           support to improve work keeping and anticipate return to employment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">June 27, 2018</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life : EORTC QLQ-C30 Scores</measure>
    <time_frame>At baseline and 5 months</time_frame>
    <description>Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001).&#xD;
15 dimensions are presented below. Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Complaints : FACT Cog Scale Scores</measure>
    <time_frame>At baseline and 5 months</time_frame>
    <description>Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3&#xD;
Assessed using median total score (range 0-132) and median scores of these 4 dimensions :&#xD;
Perceived Cognitive Impairment (range 0-72)&#xD;
Impact on quality of life (range 0-16)&#xD;
Comments from others (range 0-16)&#xD;
Perceived Cognitive Skills (range 0-28) Higher scores indicate better cognitive functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Professional Recovery Scale Scores</measure>
    <time_frame>At baseline and 5 months</time_frame>
    <description>Professional recovery was evaluated by using the Scale of motivation to Professional recovery.&#xD;
This scale was constructed for the needs of this exploratory research and has for vocation a later validation.&#xD;
It includes 62 questions and was assessed using median scores of these 7 dimensions :&#xD;
Work and administrative process (0-100)&#xD;
Positioning in relation to the job-post-mission (0-100)&#xD;
Emotion and work (0-100)&#xD;
Labour relations (0-100)&#xD;
Work and physical/intellectual conditions (0-100)&#xD;
Privacy and work (0-100)&#xD;
Return to work (0-20) Higher scores represent better outcomes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tiredness : Piper MFI-20 Scale Scores</measure>
    <time_frame>At baseline and 5 months</time_frame>
    <description>Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale&#xD;
Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions :&#xD;
Behavioural&#xD;
Emotional&#xD;
Sensory&#xD;
Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxio-depressive Troubles : HAD Scale Scores</measure>
    <time_frame>At baseline and 5 months</time_frame>
    <description>Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale.&#xD;
Assessed using median scores of these 2 dimensions :&#xD;
Anxiety&#xD;
Depression Each dimension has range 0-21 with following interpretation: higher scores represent worse outcomes (0-7 normal; 8-10 mild; 11-14 moderate; 15-21 severe)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Psychological and Social Consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychological and Social Consultation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychological and Social Consultation</intervention_name>
    <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
    <arm_group_label>Psychological and Social Consultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients attending the Institut Bergonié&#xD;
&#xD;
          -  Informed Consent signed.&#xD;
&#xD;
          -  Patients affiliated to a French social&#xD;
&#xD;
          -  living in Gironde&#xD;
&#xD;
          -  Professional activity at the time of diagnosis&#xD;
&#xD;
          -  Treated for - breast cancer, Hodgkin's or non-Hodgkin's lymphoma (non-cerebral),&#xD;
             testicular cancer&#xD;
&#xD;
          -  CURATIVE support&#xD;
&#xD;
          -  At any time during treatment (chemotherapy or radiotherapy, or immunotherapy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient deprived of liberty or subject to a legal protection measure&#xD;
&#xD;
          -  History of cancers&#xD;
&#xD;
          -  Cerebral pathology and / or brain metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Véronique GERAT-MULLER, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Bergonié - Supportive Oncology Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 12, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <results_first_submitted>January 29, 2021</results_first_submitted>
  <results_first_submitted_qc>May 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 4, 2021</results_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oncology</keyword>
  <keyword>Work Keeping</keyword>
  <keyword>Social difficulties</keyword>
  <keyword>Cognitive Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03302767/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Psychological and Social Consultation</title>
          <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Psychological and Social Consultation</title>
          <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.9" lower_limit="31.2" upper_limit="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>As a couple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Single</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Widower</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SOCIO-PROFESSIONAL CATEGORY</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>craftsman, shopkeeper, business owner</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>executive, intellectual profession</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>intermediate profession</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>employee</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>person without professional activity</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROFESSIONAL STATUS</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Public Sector</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Private Sector</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Self-employed worker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Quality of Life : EORTC QLQ-C30 Scores</title>
        <description>Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001).&#xD;
15 dimensions are presented below. Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.</description>
        <time_frame>At baseline and 5 months</time_frame>
        <population>At baseline, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients, 1 patient has missing data for the score 'Dyspnoea'.&#xD;
At 5 months, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients :&#xD;
1 patient has missing data for the scores 'Constipation' and 'Diarrhoea'&#xD;
1 another patient has missing data for the score 'Fatigue'</population>
        <group_list>
          <group group_id="O1">
            <title>Psychological and Social Consultation</title>
            <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life : EORTC QLQ-C30 Scores</title>
          <description>Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001).&#xD;
15 dimensions are presented below. Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.</description>
          <population>At baseline, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients, 1 patient has missing data for the score 'Dyspnoea'.&#xD;
At 5 months, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients :&#xD;
1 patient has missing data for the scores 'Constipation' and 'Diarrhoea'&#xD;
1 another patient has missing data for the score 'Fatigue'</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global health status/ quality of life - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.0" lower_limit="54.3" upper_limit="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global health status/ quality of life - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8" lower_limit="66.1" upper_limit="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical functioning - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.9" lower_limit="78.8" upper_limit="86.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical functioning - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" lower_limit="78.7" upper_limit="87.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role functioning - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.6" lower_limit="63.6" upper_limit="81.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role functioning - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.6" lower_limit="70.2" upper_limit="87.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional functioning - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.0" lower_limit="51.3" upper_limit="70.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional functioning - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.0" lower_limit="57.9" upper_limit="76.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive functioning - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3" lower_limit="52.7" upper_limit="69.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive functioning - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2" lower_limit="65.1" upper_limit="81.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2" lower_limit="62.9" upper_limit="83.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.1" lower_limit="73.9" upper_limit="90.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6" lower_limit="40.0" upper_limit="55.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6" lower_limit="35.3" upper_limit="52.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea/ vomiting - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="0.3" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea/ vomiting - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="-0.1" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" lower_limit="29.5" upper_limit="47.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="23.2" upper_limit="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnoea - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7" lower_limit="14.0" upper_limit="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnoea - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="8.4" upper_limit="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4" lower_limit="38.1" upper_limit="66.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7" lower_limit="29.2" upper_limit="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Appetite loss - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" lower_limit="3.6" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Appetite loss - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="0.9" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="12.0" upper_limit="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" lower_limit="3.7" upper_limit="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="1.6" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="-1.9" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Financial difficulties - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="11.3" upper_limit="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Financial difficulties - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" lower_limit="6.5" upper_limit="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cognitive Complaints : FACT Cog Scale Scores</title>
        <description>Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3&#xD;
Assessed using median total score (range 0-132) and median scores of these 4 dimensions :&#xD;
Perceived Cognitive Impairment (range 0-72)&#xD;
Impact on quality of life (range 0-16)&#xD;
Comments from others (range 0-16)&#xD;
Perceived Cognitive Skills (range 0-28) Higher scores indicate better cognitive functioning.</description>
        <time_frame>At baseline and 5 months</time_frame>
        <population>At baseline, 2 patients did not complete the Cognitive complaints questionnaire&#xD;
At 5 months, 1 patient did not complete the Cognitive complaints questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Psychological and Social Consultation</title>
            <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Complaints : FACT Cog Scale Scores</title>
          <description>Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3&#xD;
Assessed using median total score (range 0-132) and median scores of these 4 dimensions :&#xD;
Perceived Cognitive Impairment (range 0-72)&#xD;
Impact on quality of life (range 0-16)&#xD;
Comments from others (range 0-16)&#xD;
Perceived Cognitive Skills (range 0-28) Higher scores indicate better cognitive functioning.</description>
          <population>At baseline, 2 patients did not complete the Cognitive complaints questionnaire&#xD;
At 5 months, 1 patient did not complete the Cognitive complaints questionnaire</population>
          <units>scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Perceived Cognitive Impairment - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" lower_limit="8" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perceived Cognitive Impairment - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.5" lower_limit="7" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on quality of life - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="0" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on quality of life - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="0" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comments from others - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="5" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comments from others - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="3" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perceived Cognitive Skills - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="3" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perceived Cognitive Skills - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" lower_limit="0" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="16" upper_limit="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="33" upper_limit="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Professional Recovery Scale Scores</title>
        <description>Professional recovery was evaluated by using the Scale of motivation to Professional recovery.&#xD;
This scale was constructed for the needs of this exploratory research and has for vocation a later validation.&#xD;
It includes 62 questions and was assessed using median scores of these 7 dimensions :&#xD;
Work and administrative process (0-100)&#xD;
Positioning in relation to the job-post-mission (0-100)&#xD;
Emotion and work (0-100)&#xD;
Labour relations (0-100)&#xD;
Work and physical/intellectual conditions (0-100)&#xD;
Privacy and work (0-100)&#xD;
Return to work (0-20) Higher scores represent better outcomes</description>
        <time_frame>At baseline and 5 months</time_frame>
        <population>At baseline, 1 patient did not complete the Professional recovery questionnaire&#xD;
At 5 months :&#xD;
3 patients have missing data for the scores 'Work and administrative process', 'Work and physical/intellectual conditions' and 'Privacy and work'&#xD;
4 patients have missing data for the scores 'Positioning in relation to the job-post-mission', 'Emotion and work' and 'Labour relations'&#xD;
1 patient has missing data for the score 'Return to work'</population>
        <group_list>
          <group group_id="O1">
            <title>Psychological and Social Consultation</title>
            <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Professional Recovery Scale Scores</title>
          <description>Professional recovery was evaluated by using the Scale of motivation to Professional recovery.&#xD;
This scale was constructed for the needs of this exploratory research and has for vocation a later validation.&#xD;
It includes 62 questions and was assessed using median scores of these 7 dimensions :&#xD;
Work and administrative process (0-100)&#xD;
Positioning in relation to the job-post-mission (0-100)&#xD;
Emotion and work (0-100)&#xD;
Labour relations (0-100)&#xD;
Work and physical/intellectual conditions (0-100)&#xD;
Privacy and work (0-100)&#xD;
Return to work (0-20) Higher scores represent better outcomes</description>
          <population>At baseline, 1 patient did not complete the Professional recovery questionnaire&#xD;
At 5 months :&#xD;
3 patients have missing data for the scores 'Work and administrative process', 'Work and physical/intellectual conditions' and 'Privacy and work'&#xD;
4 patients have missing data for the scores 'Positioning in relation to the job-post-mission', 'Emotion and work' and 'Labour relations'&#xD;
1 patient has missing data for the score 'Return to work'</population>
          <units>scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Work and administrative process - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" lower_limit="44" upper_limit="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and administrative process - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" lower_limit="34" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positioning in relation to the job-post-mission - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.5" lower_limit="13" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positioning in relation to the job-post-mission - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="10" upper_limit="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion and work - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5" lower_limit="28" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion and work - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="33" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Labour relations - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="11" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Labour relations - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" lower_limit="28" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and physical/intellectual conditions - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" lower_limit="17" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and physical/intellectual conditions - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.5" lower_limit="28" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Privacy and work - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.5" lower_limit="29" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Privacy and work - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.5" lower_limit="25" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Return to work - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="1" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Return to work - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="2" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tiredness : Piper MFI-20 Scale Scores</title>
        <description>Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale&#xD;
Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions :&#xD;
Behavioural&#xD;
Emotional&#xD;
Sensory&#xD;
Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue</description>
        <time_frame>At baseline and 5 months</time_frame>
        <population>At baseline:&#xD;
2 patients have missing data for the scores 'Emotional dimension', Behavioural dimension' and 'Sensory dimension'&#xD;
3 patients have missing data for the score 'Cognitive-mood dimension'&#xD;
3 patients finally have missing data for 'Total Score Fatigue Scale'&#xD;
At 5 months, 1 patient did not complete the Tiredness questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Psychological and Social Consultation</title>
            <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Tiredness : Piper MFI-20 Scale Scores</title>
          <description>Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale&#xD;
Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions :&#xD;
Behavioural&#xD;
Emotional&#xD;
Sensory&#xD;
Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue</description>
          <population>At baseline:&#xD;
2 patients have missing data for the scores 'Emotional dimension', Behavioural dimension' and 'Sensory dimension'&#xD;
3 patients have missing data for the score 'Cognitive-mood dimension'&#xD;
3 patients finally have missing data for 'Total Score Fatigue Scale'&#xD;
At 5 months, 1 patient did not complete the Tiredness questionnaire</population>
          <units>scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Emotional dimension - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="1.6" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Behavioural dimension - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="0.5" upper_limit="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Behavioural dimension - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="0.0" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional dimension - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="2.0" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory dimension - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="0.6" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory dimension - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="0.8" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive-mood dimension - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="0.5" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive-mood dimension - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="0.3" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score Fatigue Scale - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="0.9" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score Fatigue Scale - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="1.5" upper_limit="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxio-depressive Troubles : HAD Scale Scores</title>
        <description>Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale.&#xD;
Assessed using median scores of these 2 dimensions :&#xD;
Anxiety&#xD;
Depression Each dimension has range 0-21 with following interpretation: higher scores represent worse outcomes (0-7 normal; 8-10 mild; 11-14 moderate; 15-21 severe)</description>
        <time_frame>At baseline and 5 months</time_frame>
        <population>At baseline, 2 patients did not complete the Anxio-depressive troubles questionnaire&#xD;
At 5 months ,1 patient did not complete the Anxio-depressive troubles questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Psychological and Social Consultation</title>
            <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Anxio-depressive Troubles : HAD Scale Scores</title>
          <description>Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale.&#xD;
Assessed using median scores of these 2 dimensions :&#xD;
Anxiety&#xD;
Depression Each dimension has range 0-21 with following interpretation: higher scores represent worse outcomes (0-7 normal; 8-10 mild; 11-14 moderate; 15-21 severe)</description>
          <population>At baseline, 2 patients did not complete the Anxio-depressive troubles questionnaire&#xD;
At 5 months ,1 patient did not complete the Anxio-depressive troubles questionnaire</population>
          <units>scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anxiety score - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="1" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety score - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="2" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression score - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="4" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression score - 5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="3" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).</desc>
      <group_list>
        <group group_id="E1">
          <title>Psychological and Social Consultation</title>
          <description>Psychological and Social Consultation at Baseline, during the study and at the end of follow-up</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Véronique GERAT-MULLER</name_or_title>
      <organization>Institut Bergonié</organization>
      <phone>0556337839</phone>
      <email>v.gerat-muller@bordeaux.unicancer.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03302767
org study id: IB2017-03
secondary id: 2017-A01251-52
nct id: NCT03302767
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This patient support system is designed to help patients regain their professional activity
      after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:

        -  A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist /
           Neuropsychologist)

        -  Monthly information meetings and workshops (TIC'Onco reunions: collective information
           times and Cogit'Onco workshops: cognitive workshops

        -  An information booklet "Prepare the work return" The aim of this research is to evaluate
           efficiency in term of quality of life improvement linked to work status, utility,
           feasibility and patients' satisfaction.

      The aim of this research is to evaluate efficiency in term of quality of life improvement
      linked to work status, utility, feasibility and patients' satisfaction.
Unmet need characterize in 4 points:

        -  Cancer and survival: challenges for cancer patients who want to work while being treated

        -  Cancer and career: Job instability for cancer patients

        -  Difficulties and isolation of patients due to a lack of coordination between healthcare
           professionals and colleagues/management

        -  Post-treatment cognitive troubles stress and hindered patient return to employment:
           chemo brain This research-action will propose and evaluate a concrete device: To
           maintain a professional activity with the support of CAP'Onco during treatment, to
           balance between quality of life, managing the "cancer event" and the psychosocial
           consequences for professional experience, to provide an early, durable and multimodal
           support to improve work keeping and anticipate return to employment
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective study
primary purpose: Supportive Care
masking: None (Open Label)
measure: Quality of Life : EORTC QLQ-C30 Scores
time frame: At baseline and 5 months
description: Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001).
15 dimensions are presented below. Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
measure: Cognitive Complaints : FACT Cog Scale Scores
time frame: At baseline and 5 months
description: Cognitive complaints were evaluated by using the french Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale version 3
Assessed using median total score (range 0-132) and median scores of these 4 dimensions :
Perceived Cognitive Impairment (range 0-72)
Impact on quality of life (range 0-16)
Comments from others (range 0-16)
Perceived Cognitive Skills (range 0-28) Higher scores indicate better cognitive functioning.
measure: Professional Recovery Scale Scores
time frame: At baseline and 5 months
description: Professional recovery was evaluated by using the Scale of motivation to Professional recovery.
This scale was constructed for the needs of this exploratory research and has for vocation a later validation.
It includes 62 questions and was assessed using median scores of these 7 dimensions :
Work and administrative process (0-100)
Positioning in relation to the job-post-mission (0-100)
Emotion and work (0-100)
Labour relations (0-100)
Work and physical/intellectual conditions (0-100)
Privacy and work (0-100)
Return to work (0-20) Higher scores represent better outcomes
measure: Tiredness : Piper MFI-20 Scale Scores
time frame: At baseline and 5 months
description: Tiredness was evaluated by using the Piper Multidimensional Fatigue Inventory (MFI-20) revised scale
Assessed using median total score (range 0-10) and median scores of these 4 tiredness dimensions :
Behavioural
Emotional
Sensory
Cognitive-mood Each dimension has range 0-10 with following interpretation: higher scores indicate greater severity of fatigue
measure: Anxio-depressive Troubles : HAD Scale Scores
time frame: At baseline and 5 months
description: Anxio-depressive troubles were evaluated by using the Hospital Anxiety and Depression (HAD) scale.
Assessed using median scores of these 2 dimensions :
Anxiety
Depression Each dimension has range 0-21 with following interpretation: higher scores represent worse outcomes (0-7 normal; 8-10 mild; 11-14 moderate; 15-21 severe)
arm group label: Psychological and Social Consultation
arm group type: Experimental
description: Psychological and Social Consultation
intervention type: Other
intervention name: Psychological and Social Consultation
description: Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
arm group label: Psychological and Social Consultation
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: No
last name: Véronique GERAT-MULLER, PhD
role: Principal Investigator
affiliation: Institut Bergonié - Supportive Oncology Care
facility: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 