<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/NCT02212132</url>
  </required_header>
  <id_info>
    <org_study_id>METACAN</org_study_id>
    <nct_id>NCT02212132</nct_id>
  </id_info>
  <brief_title>Relations Between Cognitive Complaints and Cognitive Scores Goals in Cancer: Assessment of Metamemory</brief_title>
  <official_title>Relations Between Cognitive Complaints and Cognitive Scores Goals in Cancer: Assessment of Metamemory</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Francois Baclesse</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study is, in this new and original approach in cancer pathology, measure and&#xD;
      explain the correspondence between perceived cognitive impairment (cognitive complaint) by&#xD;
      cancer patients and their cognitive scores goals with tasks metamemory while controlling the&#xD;
      anxiety and depression and fatigue factors of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The relationship between performance from neuropsychological tests and subjective complaints&#xD;
      of cancer patients treated with chemotherapy or adjuvant hormone therapy is not clear, many&#xD;
      studies have reported no significant correlation between these two measures: the perception&#xD;
      of patients' their cognitive deficits is generally increased relative to that which is&#xD;
      measured by neuropsychological testing.&#xD;
&#xD;
      The reason for this lack of association found is probably multifactorial. 1) It can be&#xD;
      explained in part by methodological limitations in some studies (lack of sensitivity tests,&#xD;
      experimental design). 2) psycho-order factors and fatigue are also an explanatory variable in&#xD;
      the sense that literature data often show that cognitive complaints are correlated with&#xD;
      levels of anxiety and depression and fatigue. 3) Finally, metacognition, often assessed in&#xD;
      neurodegenerative diseases or even in normal aging to better understand its impact on&#xD;
      cognitive disorders, including memory impairment, and the complaint has never been explored&#xD;
      in patients with cancer.&#xD;
&#xD;
      Metacognition is a complex but highly sensitive to measure and understand the patient's&#xD;
      complaint and correspondence or disagree with the actual performance concept. Metacognition&#xD;
      refers A) metacognitive knowledge, ie knowledge of an individual's own cognitive processes;&#xD;
      This is a non-dependent activity during which, upstream of the performance of any task,&#xD;
      implement an appropriate strategy, anticipate and plan cognitive steps that would be&#xD;
      necessary for its success general knowledge; and B) metacognitive experiences, ie knowledge&#xD;
      that is based on a cognitive activity in progress, which allows to monitor and control the&#xD;
      task in order to maintain or otherwise modify the cognitive processes involved.&#xD;
&#xD;
      While metacognitive knowledge (A) are assessed by multiple choice questionnaires,&#xD;
      metacognitive experiences (B) allow targeted and precise fine measures of correspondence&#xD;
      between the prediction performance by the patient himself and his actual performance a&#xD;
      mnemonic task (for JOL and FOK Judgment of Learning for Feeling Of Knowing). Studies&#xD;
      exploring the effects of age on metamemory usually show a deficit of these metacognitive&#xD;
      experiences in normal aging compared to young subjects.&#xD;
&#xD;
      Collected at the time of learning, JOL is a prediction of future performance for information&#xD;
      that have just been learned. More specifically, when learning words, the subject must judge&#xD;
      its ability to further free recall for each item (quantitative data). This prediction is then&#xD;
      compared to the actual memory performance found in the free recall task. This comparison&#xD;
      allows to judge the accuracy of the prediction and therefore the accuracy of metamemory&#xD;
      judgment.&#xD;
&#xD;
      The FOK corresponds to a prediction of performance information that could not be provided in&#xD;
      free recall recognition. In practice, when an item is not recovered in free recall, the&#xD;
      subject must judge its ability to recognize the correct answer among distractor responses.&#xD;
&#xD;
      Metacognitive processes can refer to the field of memory (metamemory) or attention&#xD;
      (métaattention), but for now metamemory was much valued neuropsychological tests and the&#xD;
      testing and are most successful and many more.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of metamemory through questionnaires</measure>
    <time_frame>At study entry</time_frame>
    <description>Comparison with questionnaires completed by healthy subjects matched controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of anxiety and depression and fatigue factors on metamemory.</measure>
    <time_frame>At study entry</time_frame>
    <description>Search by questionnaires the influence of anxiety and depression and fatigue factors on metamemory.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Metamemory</condition>
  <condition>Memory Complaints</condition>
  <condition>Performance Mnemonic</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <description>Neuropsychological evaluation, psychopathological assessment and fatigue</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Neuropsychological evaluation, psychopathological assessment and fatigue</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>behavioral assessments</intervention_name>
    <description>Neuropsychological evaluation, psychopathological assessment and fatigue</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient being treated for a solid tumor or hematological&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient being treated for a solid or hematologic malignancy;&#xD;
&#xD;
          -  Patients under 65 years of age;&#xD;
&#xD;
          -  Patients Grade 3 'end primary school &quot;minimum (scale Barbizet);&#xD;
&#xD;
          -  Primary cancer of the central nervous system or brain metastases Absence;&#xD;
&#xD;
          -  No major cognitive disorders;&#xD;
&#xD;
          -  Lack of previous neurological;&#xD;
&#xD;
          -  Lack of personality disorders and evolutionary psychiatric pathology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with paraneoplastic syndrome;&#xD;
&#xD;
          -  Scalable psychiatric pathology;&#xD;
&#xD;
          -  Refusal to participate;&#xD;
&#xD;
          -  Patients unable to meet the cognitive tests;&#xD;
&#xD;
          -  Use of drugs;&#xD;
&#xD;
          -  Heavy drinking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florence JOLY, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre François Baclesse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 5, 2015</last_update_submitted>
  <last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metamemory</keyword>
  <keyword>memory complaints</keyword>
  <keyword>performance mnemonic</keyword>
  <keyword>cancer</keyword>
  <!-- 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/NCT02212132
org study id: METACAN
nct id: NCT02212132
lead sponsor: 
has dmc: Yes
This pilot study is, in this new and original approach in cancer pathology, measure and
      explain the correspondence between perceived cognitive impairment (cognitive complaint) by
      cancer patients and their cognitive scores goals with tasks metamemory while controlling the
      anxiety and depression and fatigue factors of patients.
The relationship between performance from neuropsychological tests and subjective complaints
      of cancer patients treated with chemotherapy or adjuvant hormone therapy is not clear, many
      studies have reported no significant correlation between these two measures: the perception
      of patients' their cognitive deficits is generally increased relative to that which is
      measured by neuropsychological testing.

      The reason for this lack of association found is probably multifactorial. 1) It can be
      explained in part by methodological limitations in some studies (lack of sensitivity tests,
      experimental design). 2) psycho-order factors and fatigue are also an explanatory variable in
      the sense that literature data often show that cognitive complaints are correlated with
      levels of anxiety and depression and fatigue. 3) Finally, metacognition, often assessed in
      neurodegenerative diseases or even in normal aging to better understand its impact on
      cognitive disorders, including memory impairment, and the complaint has never been explored
      in patients with cancer.

      Metacognition is a complex but highly sensitive to measure and understand the patient's
      complaint and correspondence or disagree with the actual performance concept. Metacognition
      refers A) metacognitive knowledge, ie knowledge of an individual's own cognitive processes;
      This is a non-dependent activity during which, upstream of the performance of any task,
      implement an appropriate strategy, anticipate and plan cognitive steps that would be
      necessary for its success general knowledge; and B) metacognitive experiences, ie knowledge
      that is based on a cognitive activity in progress, which allows to monitor and control the
      task in order to maintain or otherwise modify the cognitive processes involved.

      While metacognitive knowledge (A) are assessed by multiple choice questionnaires,
      metacognitive experiences (B) allow targeted and precise fine measures of correspondence
      between the prediction performance by the patient himself and his actual performance a
      mnemonic task (for JOL and FOK Judgment of Learning for Feeling Of Knowing). Studies
      exploring the effects of age on metamemory usually show a deficit of these metacognitive
      experiences in normal aging compared to young subjects.

      Collected at the time of learning, JOL is a prediction of future performance for information
      that have just been learned. More specifically, when learning words, the subject must judge
      its ability to further free recall for each item (quantitative data). This prediction is then
      compared to the actual memory performance found in the free recall task. This comparison
      allows to judge the accuracy of the prediction and therefore the accuracy of metamemory
      judgment.

      The FOK corresponds to a prediction of performance information that could not be provided in
      free recall recognition. In practice, when an item is not recovered in free recall, the
      subject must judge its ability to recognize the correct answer among distractor responses.

      Metacognitive processes can refer to the field of memory (metamemory) or attention
      (métaattention), but for now metamemory was much valued neuropsychological tests and the
      testing and are most successful and many more.
time perspective: Prospective
measure: Evaluation of metamemory through questionnaires
time frame: At study entry
description: Comparison with questionnaires completed by healthy subjects matched controls.
measure: Influence of anxiety and depression and fatigue factors on metamemory.
time frame: At study entry
description: Search by questionnaires the influence of anxiety and depression and fatigue factors on metamemory.
arm group label: Patient
description: Neuropsychological evaluation, psychopathological assessment and fatigue
arm group label: Control group
description: Neuropsychological evaluation, psychopathological assessment and fatigue
intervention type: Other
intervention name: behavioral assessments
description: Neuropsychological evaluation, psychopathological assessment and fatigue
arm group label: Control group
arm group label: Patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Florence JOLY, PhD
role: Principal Investigator
affiliation: Centre François Baclesse
facility: 
country: France
responsible party type: Sponsor