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/NCT06027632</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A01134-41</org_study_id>
      <nct_id>NCT06027632</nct_id>
    </id_info>
    <brief_title>Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer</brief_title>
    <acronym>COG STIM 2</acronym>
    <official_title>Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer: a Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Francois Baclesse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>UNICANCER</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Francois Baclesse</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>
        Investigator propose the first French randomized comparative study to assess the efficacy of&#xD;
        a remotely supervised online cognitive stimulation program, compared to an unsupervised&#xD;
        online cognitive exercise intervention, in reducing cognitive complaints in localized breast&#xD;
        cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the&#xD;
        effectiveness of online cognitive stimulation programs compared to standard care. The study&#xD;
        seeks to determine the added value of remote supervision by a neuropsychologist. The control&#xD;
        group will have access to the same online cognitive exercises as the experimental group but&#xD;
        without supervision. Investigator has chosen not to include a wait-list group as it would be&#xD;
        unethical to deny patients with cognitive complaints the opportunity to participate in an&#xD;
        intervention expected to benefit them. The secondary objective is to evaluate the benefit of&#xD;
        the supervised digitalized cognitive intervention on objective cognitive impairment.&#xD;
  &#xD;
        The research hypothesis is that incorporating personalized remote support with supervision&#xD;
        from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the&#xD;
        effectiveness of the intervention on cognitive complaints. This will be achieved by improving&#xD;
        participation/adherence to the online cognitive stimulation program, as well as through the&#xD;
        personalized supervision itself. Investigator believe that the supervision sessions,&#xD;
        including educational components, will enable patients to identify their strengths, promote&#xD;
        their cognitive awareness, and develop individualized strategies to apply their compensatory&#xD;
        abilities in real-life situations. Since cognitive difficulties have multiple underlying&#xD;
        causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that&#xD;
        combining cognitive training (which increases neuroplasticity and directly targets the&#xD;
        cognitive domains affected by cancer and its treatments), with structured supervised&#xD;
        educational sessions based on compensatory strategies, will yield better outcomes than online&#xD;
        cognitive stimulation alone.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2029</completion_date>
    <primary_completion_date type="Anticipated">June 2028</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>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Average change in the score of the Perceived Cognitive Impairment (PCI) subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)</measure>
      <time_frame>After 12 weeks</time_frame>
      <description>Perceived Cognitive Impairment (PCI) score range 0-72 (The higher the score, the fewer cognitive complaints)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Cognitive Dysfunction</condition>
    <arm_group>
      <arm_group_label>Remotely-supervised online cognitive stimulation intervention</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Open access to online home-based cognitive exercises without supervision</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cognitive exercises with supervision</intervention_name>
      <description>The experimental group will receive a 12-week intervention consisting of three 20-minute online cognitive stimulation sessions per week along with a weekly 30-minute centralized online remote supervision session with a neuropsychologist. Patient will also have access to the &quot;PRESCO&quot; program of the &quot;HAPPYNeuron-Pro&quot; software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed</description>
      <arm_group_label>Remotely-supervised online cognitive stimulation intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cognitive exercises without supervision</intervention_name>
      <description>Patient will have access to the program named &quot;PRESCO&quot; of the &quot;HAPPYNeuron-Pro&quot; software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed</description>
      <arm_group_label>Open access to online home-based cognitive exercises without supervision</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient diagnosed with localized breast cancer&#xD;
  &#xD;
            -  Age 18 or older,&#xD;
  &#xD;
            -  Who have received adjuvant or neo-adjuvant chemotherapy and are currently undergoing&#xD;
               adjuvant radiotherapy (ongoing hormone therapy is permitted) until 30 days after end&#xD;
               of radiotherapy.&#xD;
  &#xD;
            -  Patients who report cognitive complaints that significantly impact their quality of&#xD;
               life, as evaluated by the quality of life subscale of the FACT-Cog questionnaire. This&#xD;
               subscale is composed by 4 questions:&#xD;
  &#xD;
                 1. I have been upset about these problems;&#xD;
  &#xD;
                 2. These problems have interfered with my ability to work;&#xD;
  &#xD;
                 3. These problems have interfered with my ability to do things I enjoy;&#xD;
  &#xD;
                 4. These problems have interfered with the quality of my life.&#xD;
  &#xD;
          Patients are eligible if their score on this subscale is at or below the 10th percentile,&#xD;
          based on age guidelines and normative data (Lange et al., 2015), namely:&#xD;
  &#xD;
            -  ≤ 8 for patients aged 30-49 years&#xD;
  &#xD;
            -  ≤ 9 for patients aged 50-69 years&#xD;
  &#xD;
            -  ≤ 10 for patients aged 70-89 years&#xD;
  &#xD;
                 -  Patients who have completed at least three years of primary school education, as&#xD;
                    determined by the Barbizet scale,&#xD;
  &#xD;
                 -  Patient with access to a functional laptop/computer with a keyboard, internet&#xD;
                    connection and an e-mail account - being able to use those tools alone,&#xD;
  &#xD;
                 -  Fluent in French,&#xD;
  &#xD;
                 -  Patients who have provided informed consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Personality disorder or any known progressive psychiatric pathology (e.g.&#xD;
               schizophrenia),&#xD;
  &#xD;
            -  Previous neurological history with ongoing cognitive symptoms (sequelae of head&#xD;
               trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.),&#xD;
  &#xD;
            -  Excessive alcohol intake or drug use, which could compromise participation to the&#xD;
               intervention&#xD;
  &#xD;
            -  Major visual and/or hearing deficit,&#xD;
  &#xD;
            -  Patient who might not be able to complete neuropsychological testing, (including those&#xD;
               with significant cognitive disorders that impede the completion of cognition tests, as&#xD;
               determined by the cognitive screening test MoCA (MONTREAL COGNITIVE ASSESSMENT) and&#xD;
               based on age and educational level according to GRECOGVASC (Reflection Group for&#xD;
               Vascular COGnitive Assessment) normative data)&#xD;
  &#xD;
            -  Already participating in a cognitive training program,&#xD;
  &#xD;
            -  Refusal to participate,&#xD;
  &#xD;
            -  Patient deprived of liberty or under guardianship,&#xD;
  &#xD;
            -  Patient who might not be able to participate due to geographic, social or&#xD;
               psychopathological reasons.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Months</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Polyclinique Bordeaux Nord Aquitaine</name>
        <address>
          <city>Bordeaux</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Nadine DOHOLLOU, MD</last_name>
      </contact>
      <investigator>
        <last_name>Nadine DOHOLLOU, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre hospitalier de Bligny</name>
        <address>
          <city>Briis-sous-Forges</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean-Baptiste MERIC, MD</last_name>
      </contact>
      <investigator>
        <last_name>Jean-Baptiste MERIC, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre François Baclesse</name>
        <address>
          <city>Caen</city>
          <zip>14000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Florence JOLY, PhD</last_name>
        <phone>+33 2 31 45 50 50</phone>
        <email>f.joly@baclesse.unicancer.fr</email>
      </contact>
      <contact_backup>
        <last_name>Jean-Michel GRELLARD</last_name>
        <phone>+33 2 31 45 50 50</phone>
        <email>jm.grellard@baclesse.unicancer.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Florence JOLY, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre George François Leclerc</name>
        <address>
          <city>Dijon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Didier MAYEUR, MD</last_name>
      </contact>
      <investigator>
        <last_name>Didier MAYEUR, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Groupe Hospitalier Mutualiste de Grenoble</name>
        <address>
          <city>Grenoble</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Olivia DIAZ, MD</last_name>
      </contact>
      <investigator>
        <last_name>Olivia DIAZ, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHU de Limoges</name>
        <address>
          <city>Limoges</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Elodie DELUCHE, MD</last_name>
      </contact>
      <investigator>
        <last_name>Elodie DELUCHE, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Léon Bérard</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Benoite MERY, MD</last_name>
      </contact>
      <investigator>
        <last_name>Benoite MERY, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Institut Paoli Calmettes</name>
        <address>
          <city>Marseille</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Lorene SEGUIN, MD</last_name>
      </contact>
      <investigator>
        <last_name>Lorene SEGUIN, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ICM Val d'Aurelle</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Estelle GUERDOUX</last_name>
      </contact>
      <investigator>
        <last_name>Estelle GUERDOUX</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Institut de Cancérologie de Lorraine</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Camille SIMON, MD</last_name>
      </contact>
      <investigator>
        <last_name>Camille SIMON, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Antoine Lacassagne</name>
        <address>
          <city>Nice</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Pierre-Yves BONDIAU, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Pierre-Yves BONDIAU, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHU de Nimes</name>
        <address>
          <city>Nimes</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Frederic FITENI, MD</last_name>
      </contact>
      <investigator>
        <last_name>Frederic FITENI, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>La Pitié Salpétrière</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Johanna WASSERMANN, MD</last_name>
      </contact>
      <investigator>
        <last_name>Johanna WASSERMANN, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Arrmoricain d'Oncologie</name>
        <address>
          <city>Plérin</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jérôme MARTIN-BABAU, MD</last_name>
      </contact>
      <investigator>
        <last_name>Jérôme MARTIN-BABAU, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Henri Becquerel</name>
        <address>
          <city>Rouen</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Olivier RIGAL, MD</last_name>
      </contact>
      <investigator>
        <last_name>Olivier RIGAL, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Gustave Roussy</name>
        <address>
          <city>Villejuif</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Antonio DI MEGLIO, MD</last_name>
      </contact>
      <investigator>
        <last_name>Antonio DI MEGLIO, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Breast Neoplasms</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06027632
  org study id: 2023-A01134-41
  nct id: NCT06027632
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigator propose the first French randomized comparative study to assess the efficacy of
        a remotely supervised online cognitive stimulation program, compared to an unsupervised
        online cognitive exercise intervention, in reducing cognitive complaints in localized breast
        cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the
        effectiveness of online cognitive stimulation programs compared to standard care. The study
        seeks to determine the added value of remote supervision by a neuropsychologist. The control
        group will have access to the same online cognitive exercises as the experimental group but
        without supervision. Investigator has chosen not to include a wait-list group as it would be
        unethical to deny patients with cognitive complaints the opportunity to participate in an
        intervention expected to benefit them. The secondary objective is to evaluate the benefit of
        the supervised digitalized cognitive intervention on objective cognitive impairment.
  
        The research hypothesis is that incorporating personalized remote support with supervision
        from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the
        effectiveness of the intervention on cognitive complaints. This will be achieved by improving
        participation/adherence to the online cognitive stimulation program, as well as through the
        personalized supervision itself. Investigator believe that the supervision sessions,
        including educational components, will enable patients to identify their strengths, promote
        their cognitive awareness, and develop individualized strategies to apply their compensatory
        abilities in real-life situations. Since cognitive difficulties have multiple underlying
        causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that
        combining cognitive training (which increases neuroplasticity and directly targets the
        cognitive domains affected by cancer and its treatments), with structured supervised
        educational sessions based on compensatory strategies, will yield better outcomes than online
        cognitive stimulation alone.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Average change in the score of the Perceived Cognitive Impairment (PCI) subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
  time frame: After 12 weeks
  description: Perceived Cognitive Impairment (PCI) score range 0-72 (The higher the score, the fewer cognitive complaints)
  arm group label: Remotely-supervised online cognitive stimulation intervention
  arm group type: Other
  arm group label: Open access to online home-based cognitive exercises without supervision
  arm group type: Other
  intervention type: Other
  intervention name: Cognitive exercises with supervision
  description: The experimental group will receive a 12-week intervention consisting of three 20-minute online cognitive stimulation sessions per week along with a weekly 30-minute centralized online remote supervision session with a neuropsychologist. Patient will also have access to the "PRESCO" program of the "HAPPYNeuron-Pro" software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed
  arm group label: Remotely-supervised online cognitive stimulation intervention
  intervention type: Other
  intervention name: Cognitive exercises without supervision
  description: Patient will have access to the program named "PRESCO" of the "HAPPYNeuron-Pro" software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed
  arm group label: Open access to online home-based cognitive exercises without supervision
  criteria: 
  gender: Female
  minimum age: 18 Months
  maximum age: N/A
  healthy volunteers: No
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  country: France
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Cognitive Dysfunction
  sharing ipd: No