<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/NCT03240341</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01</org_study_id>
    <secondary_id>2017-A00235-48</secondary_id>
    <nct_id>NCT03240341</nct_id>
  </id_info>
  <brief_title>Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway</brief_title>
  <acronym>PARACT</acronym>
  <official_title>Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hôpital Privé de la Loire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Emile Roux</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinique de l'infirmerie protestante de Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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 is to implement the Patient Activation Measure in paramedical practices as a tool to&#xD;
      measure activation of patients in cancer care&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">October 20, 2022</completion_date>
  <primary_completion_date type="Actual">October 28, 2021</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Activation Measure Questionnaire</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure Questionnaire</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale for confidence level measurement about treatment</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression HAD Questionnaire</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>REALM Health Literacy Test</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire EQ-5D</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patient Activation Measure (PAM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>completion of the PAM questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Activation Measure Questionnaire</intervention_name>
    <description>Measure the level of patient engagement in cancer care pathway</description>
    <arm_group_label>Patient Activation Measure (PAM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Cancer patient with an estimated life expectancy of at least one year&#xD;
&#xD;
          -  Patient requiring immunotherapy or intravenous chemotherapy for any cancer according&#xD;
             to the decision of the Multidisciplinary Consultation Meeting&#xD;
&#xD;
          -  Patient affiliated or entitled to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate, protected adult patient under guardianship.&#xD;
&#xD;
          -  Patient disability to understand the course of the study&#xD;
&#xD;
          -  Patient with documented history of cognitive or psychiatric disorders.&#xD;
&#xD;
          -  Patient not understanding French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre Fournel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Emile Roux</name>
      <address>
        <city>Le Puy-en-Velay</city>
        <zip>43000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de l'infirmerie protestante de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Roanne</name>
      <address>
        <city>Roanne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé de la Loire</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03240341
org study id: 2017-01
secondary id: 2017-A00235-48
nct id: NCT03240341
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to implement the Patient Activation Measure in paramedical practices as a tool to
      measure activation of patients in cancer care
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient Activation Measure Questionnaire
time frame: 12 month
measure: Patient Activation Measure Questionnaire
time frame: 6 and 12 months
measure: Visual Analog Scale for confidence level measurement about treatment
time frame: 6 and 12 months
measure: Anxiety and Depression HAD Questionnaire
time frame: 6 and 12 months
measure: REALM Health Literacy Test
time frame: 6 and 12 months
measure: Quality of Life Questionnaire EQ-5D
time frame: 6 and 12 months
arm group label: Patient Activation Measure (PAM)
arm group type: Experimental
description: completion of the PAM questionnaire
intervention type: Behavioral
intervention name: Patient Activation Measure Questionnaire
description: Measure the level of patient engagement in cancer care pathway
arm group label: Patient Activation Measure (PAM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Fournel, MD
role: Principal Investigator
affiliation: CHU de Saint-Etienne
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No