xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977062</url>
    </required_header>
    <id_info>
      <org_study_id>2021-A01891-40</org_study_id>
      <secondary_id>2021/3317</secondary_id>
      <nct_id>NCT05977062</nct_id>
    </id_info>
    <brief_title>Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia</brief_title>
    <acronym>Sleep-4-All-2</acronym>
    <official_title>Sleep-4-all-2.0 Study: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia - A Prospective Real-life Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gustave Roussy, Cancer Campus, Grand Paris</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>
        Determine who can benefit from additional follow-up by a professional and what type of help&#xD;
        is most appropriate (need and expectation of patients in terms of support by a health&#xD;
        professional)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 25, 2022</start_date>
    <completion_date type="Anticipated">October 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 13, 2023</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>Evolution of the ISI score</measure>
      <time_frame>until 24 weeks after enrolment</time_frame>
      <description>The primary outcome is to evaluate the evolution of the ISI score of patients with score &gt; 8.&#xD;
  ISI = Index de Sévérité de l'Insomnie. Score &gt; 8 means the patient has insomnia issue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient insomnia perception</measure>
      <time_frame>until 24 weeks after enrolment</time_frame>
      <description>Two ad-hoc items will be proposed to the participants to determine if insomnia is considered as a problem for them (outcome perception), and as a problem important to solve (outcome expectancy).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to the intervention</measure>
      <time_frame>until 24 weeks after enrolment</time_frame>
      <description>The frequency and the evolution of connections (A/globally, namely total number of connections per week and during all the intervention; B/potential differences in the frequency of connections throughout the weeks);&#xD;
  the type and proportion of components effectively consulted (videos, modules, and tools);&#xD;
  the duration of the use of the study web platform (total number of weeks).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">322</enrollment>
    <condition>Cancer</condition>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>Coaching arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Self screening</intervention_name>
      <description>Score ISI (Index de Sévérité de l'Insomnie)</description>
      <arm_group_label>Coaching arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Phone call</intervention_name>
      <description>Phone call at the beginning of the program and at the middle and at the end.</description>
      <arm_group_label>Coaching arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Online questionnaires</intervention_name>
      <description>To be completed at week 1, 6, 12 and 24.</description>
      <arm_group_label>Coaching arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults patients,&#xD;
  &#xD;
            -  With a diagnosis of localized or metastatic cancer,&#xD;
  &#xD;
            -  During or after their treatment,&#xD;
  &#xD;
            -  In one of the following three cancer centres: Gustave Roussy (Villejuif), Montpellier&#xD;
               Cancer Institute (Montpellier), and Léon Bérard Center (Lyon)&#xD;
  &#xD;
            -  With a significative score on the self-screening Insomnia Severity Index score (ISI ≥&#xD;
               8)&#xD;
  &#xD;
            -  Able to readily read and understand French,&#xD;
  &#xD;
            -  Able to use informatic tools confidently and with Internet access,&#xD;
  &#xD;
            -  Who have signed the online consent form,&#xD;
  &#xD;
            -  Affiliated to a social security system or beneficiary of the same.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with a visual, hearing or cognitive disability that is incompatible with the&#xD;
               study,&#xD;
  &#xD;
            -  Simultaneous participation in another study evaluating a treatment of insomnia,&#xD;
  &#xD;
            -  Patient under guardianship or deprived of his liberty by a judicial or administrative&#xD;
               decision or incapable of giving its consent.&#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>Diane BOINON, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Centre Léon Bérard</name>
        <address>
          <city>Lyon</city>
          <zip>69008</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Institut de Cancérologie de Montpellier</name>
        <address>
          <city>Montpellier</city>
          <zip>34090</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Gustave Roussy</name>
        <address>
          <city>Villejuif</city>
          <zip>94805</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977062
  org study id: 2021-A01891-40
  secondary id: 2021/3317
  nct id: NCT05977062
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Determine who can benefit from additional follow-up by a professional and what type of help
        is most appropriate (need and expectation of patients in terms of support by a health
        professional)
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Evolution of the ISI score
  time frame: until 24 weeks after enrolment
  description: The primary outcome is to evaluate the evolution of the ISI score of patients with score > 8.
  ISI = Index de Sévérité de l'Insomnie. Score > 8 means the patient has insomnia issue.
  measure: Patient insomnia perception
  time frame: until 24 weeks after enrolment
  description: Two ad-hoc items will be proposed to the participants to determine if insomnia is considered as a problem for them (outcome perception), and as a problem important to solve (outcome expectancy).
  measure: Adherence to the intervention
  time frame: until 24 weeks after enrolment
  description: The frequency and the evolution of connections (A/globally, namely total number of connections per week and during all the intervention; B/potential differences in the frequency of connections throughout the weeks);
  the type and proportion of components effectively consulted (videos, modules, and tools);
  the duration of the use of the study web platform (total number of weeks).
  arm group label: Coaching arm
  arm group type: Other
  intervention type: Other
  intervention name: Self screening
  description: Score ISI (Index de Sévérité de l'Insomnie)
  arm group label: Coaching arm
  intervention type: Other
  intervention name: Phone call
  description: Phone call at the beginning of the program and at the middle and at the end.
  arm group label: Coaching arm
  intervention type: Other
  intervention name: Online questionnaires
  description: To be completed at week 1, 6, 12 and 24.
  arm group label: Coaching arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Diane BOINON, MD
  role: Study Chair
  affiliation: Gustave Roussy, Cancer Campus, Grand Paris
  facility: 
  facility: 
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Sleep Initiation and Maintenance Disorders