<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/NCT03306693</url>
  </required_header>
  <id_info>
    <org_study_id>2016_29</org_study_id>
    <secondary_id>2017-A00224-49</secondary_id>
    <nct_id>NCT03306693</nct_id>
  </id_info>
  <brief_title>Educational Intervention to Increase the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers</brief_title>
  <acronym>EmoVie_K</acronym>
  <official_title>Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SIRIC ONCOLille</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Santelys Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      The aim of this study is to test whether a short educational intervention about emotional&#xD;
      skills can improve survivor cancer patient emotional skills and quality of life. Half of&#xD;
      participants will follow the educational intervention about emotional skills, while the other&#xD;
      half will practice relaxation followed by a non-directive talking group. The educational&#xD;
      intervention should give better results on patient emotional skills and quality of life than&#xD;
      the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the end of treatments, cancer patients face a difficult time because it is expected&#xD;
      that they return to normal, but at the same time they still have to struggle with the&#xD;
      aftermath of cancer and fear of recurrence. This is why there is room in this period for an&#xD;
      intervention designed to help patients to cope with their emotions. . Patient emotional&#xD;
      skills are patient abilities to identify, express and manage their emotions for the best&#xD;
      possible psychological adjustment. In general population, emotional skills have been shown to&#xD;
      be highly related to a better quality of life. In this randomized controlled study,&#xD;
      bronchopulmonary and oesogastric cancer patients between 6 months and 2 years after the end&#xD;
      of treatments will undergo either the emotional skills intervention (intervention group) or&#xD;
      the relaxation group (control group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient inclusions&#xD;
  </why_stopped>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">May 7, 2019</completion_date>
  <primary_completion_date type="Actual">May 7, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient emotional skills from baseline to 15 days after intervention</measure>
    <time_frame>Baseline and 15 days after the end of the intervention</time_frame>
    <description>Variation of patient-reported Short Profile of Emotional Competence (S-PEC)questionnaire score from baseline to 15 days after the intervention (between 1 and 3 months)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient emotional skills long term</measure>
    <time_frame>T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months</time_frame>
    <description>Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)</measure>
    <time_frame>Baseline (T0), 15 days after the end of the intervention (T1), 2 months</time_frame>
    <description>Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient participation in workshops</measure>
    <time_frame>Between 2 weeks and 2 months</time_frame>
    <description>The percentage of patients who have attended the 3 group sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient adherence to exercises to do at home between sessions</measure>
    <time_frame>Between 2 weeks and 2 months</time_frame>
    <description>The percentage of patients who have performed the suggested exercises at home between sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>T1 (15 days after the end of the intervention) and T2 (2 months after T1)</time_frame>
    <description>Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Digestive System Neoplasms</condition>
  <condition>Thoracic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Emotional skills</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 group sessions where patients are going to learn how to identify, express and regulate their emotions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation and talking group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotional skills</intervention_name>
    <description>2-hour 3 group sessions</description>
    <arm_group_label>Emotional skills</arm_group_label>
    <other_name>Emotional intelligence</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation and talking group</intervention_name>
    <description>2-hour 3 group sessions</description>
    <arm_group_label>Relaxation and talking group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 ans,&#xD;
&#xD;
          -  Oesogastric or bronchopulmonary cancer patients between 6 months and 2 years after the&#xD;
             end of cancer treatments&#xD;
&#xD;
          -  Patient of the CHRU (Regional Teaching Hospital) of Lille,&#xD;
&#xD;
          -  Registered with a social security scheme&#xD;
&#xD;
          -  Speak and understand French language&#xD;
&#xD;
          -  Signature of the informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive disorders or unstabilized psychiatric disorders that may impair the ability&#xD;
             of reasoning and thinking necessary to complete the questionnaires and attend&#xD;
             workshops&#xD;
&#xD;
          -  Difficulty or deficiency that prevent the patient from a good understanding of the&#xD;
             imperatives of the research&#xD;
&#xD;
          -  Any situation likely to significantly affect emotional competence during the study&#xD;
             according to the investigator's judgment (in particular, ongoing psychotherapy )&#xD;
&#xD;
          -  Patients under judicial protection (guardianship or curators).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Calmette,CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emotional Intelligence</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Thoracic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306693
org study id: 2016_29
secondary id: 2017-A00224-49
nct id: NCT03306693
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to test whether a short educational intervention about emotional
      skills can improve survivor cancer patient emotional skills and quality of life. Half of
      participants will follow the educational intervention about emotional skills, while the other
      half will practice relaxation followed by a non-directive talking group. The educational
      intervention should give better results on patient emotional skills and quality of life than
      the control group.
After the end of treatments, cancer patients face a difficult time because it is expected
      that they return to normal, but at the same time they still have to struggle with the
      aftermath of cancer and fear of recurrence. This is why there is room in this period for an
      intervention designed to help patients to cope with their emotions. . Patient emotional
      skills are patient abilities to identify, express and manage their emotions for the best
      possible psychological adjustment. In general population, emotional skills have been shown to
      be highly related to a better quality of life. In this randomized controlled study,
      bronchopulmonary and oesogastric cancer patients between 6 months and 2 years after the end
      of treatments will undergo either the emotional skills intervention (intervention group) or
      the relaxation group (control group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in patient emotional skills from baseline to 15 days after intervention
time frame: Baseline and 15 days after the end of the intervention
description: Variation of patient-reported Short Profile of Emotional Competence (S-PEC)questionnaire score from baseline to 15 days after the intervention (between 1 and 3 months)
measure: Patient emotional skills long term
time frame: T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months
description: Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score
measure: Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
time frame: Baseline (T0), 15 days after the end of the intervention (T1), 2 months
description: Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
measure: Patient participation in workshops
time frame: Between 2 weeks and 2 months
description: The percentage of patients who have attended the 3 group sessions
measure: Patient adherence to exercises to do at home between sessions
time frame: Between 2 weeks and 2 months
description: The percentage of patients who have performed the suggested exercises at home between sessions
measure: Patient satisfaction
time frame: T1 (15 days after the end of the intervention) and T2 (2 months after T1)
description: Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire
arm group label: Emotional skills
arm group type: Experimental
description: 3 group sessions where patients are going to learn how to identify, express and regulate their emotions
arm group label: Relaxation and talking group
arm group type: Sham Comparator
description: 3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer
intervention type: Behavioral
intervention name: Emotional skills
description: 2-hour 3 group sessions
arm group label: Emotional skills
other name: Emotional intelligence
intervention type: Behavioral
intervention name: Relaxation and talking group
description: 2-hour 3 group sessions
arm group label: Relaxation and talking group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Thoracic Neoplasms