<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/NCT04490733</url>
  </required_header>
  <id_info>
    <org_study_id>201912231RINC</org_study_id>
    <nct_id>NCT04490733</nct_id>
  </id_info>
  <brief_title>Developing Risk Prediction Model and Testing the Effect of Dual Task Walking on Improving Cognitive Function in Patients With Colorectal Cancer</brief_title>
  <official_title>Developing Risk Prediction Model of Mild Cognitive Impairment in Patients With Colorectal Cancer From Active Treatment to Survivor and Testing the Effect of Dual Task Walking on Improving Cognitive Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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 aims of this three-year study are to explore cognitive function under different stages of&#xD;
      colorectal cancer (CRC) and its related factors; and understand its disturbance and coping&#xD;
      process caused by cancer-induced cognitive impairment (CICI) from patient perspective; and&#xD;
      further to test effect of dual-task walking on improving cognitive function in CRC patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Developing risk prediction model of mild cognitive impairment in patients with colorectal&#xD;
      cancer from active treatment to survivor by exploring the effect of surgery and chemotherapy&#xD;
      on CICI, and to identify high risk population; and testing the effect of dual-task walking on&#xD;
      improving cognitive function (memory, executive function and attention) in CRC patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-report Questionnaire</measure>
    <time_frame>Change from baseline cognitive function at 12 months</time_frame>
    <description>The questionnaire includes 37 items to assess perceived cognitive function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychological battery test</measure>
    <time_frame>Change from baseline cognitive function at 12 months</time_frame>
    <description>Three neuropsychological battery tests will be used to assess cognitive function of executive function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychological battery test</measure>
    <time_frame>Change from baseline cognitive function at 12 months</time_frame>
    <description>One neuropsychological battery test will be used to assess cognitive function of attention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychological battery test</measure>
    <time_frame>Change from baseline cognitive function at 12 months</time_frame>
    <description>Five neuropsychological battery tests will be used to assess cognitive function of memory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-report Questionnaire</measure>
    <time_frame>Change from baseline symptom at 12 months</time_frame>
    <description>The questionnaire includes 24 items to assess symptom severity</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-report Questionnaire</measure>
    <time_frame>Change from baseline fatigue at 12 months</time_frame>
    <description>The questionnaire includes 15 items to assess fatigue level</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-report Questionnaire</measure>
    <time_frame>Change from baseline depression symptom at 12 months</time_frame>
    <description>The questionnaire includes 20 items to assess frequency of depression symptom</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">355</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in control group will receive usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>dual-task walking</intervention_name>
    <description>Participants will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly diagnosed stage I to III colorectal cancer and Montreal Cognitive&#xD;
             Assessment (MoCA) &lt; 24.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cancer other than colorectal cancer or have cancer recurrence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiow-Ching Shun, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shiow-Ching Shun, PHD</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>88439</phone_ext>
    <email>scshun@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiow-Ching Shun, PHD</last_name>
      <phone>886-2-2312-3456</phone>
      <phone_ext>88439</phone_ext>
      <email>scshun@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colorectal cancer</keyword>
  <keyword>cognitive impairment</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>dual-task walking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04490733
org study id: 201912231RINC
nct id: NCT04490733
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aims of this three-year study are to explore cognitive function under different stages of
      colorectal cancer (CRC) and its related factors; and understand its disturbance and coping
      process caused by cancer-induced cognitive impairment (CICI) from patient perspective; and
      further to test effect of dual-task walking on improving cognitive function in CRC patients.
Developing risk prediction model of mild cognitive impairment in patients with colorectal
      cancer from active treatment to survivor by exploring the effect of surgery and chemotherapy
      on CICI, and to identify high risk population; and testing the effect of dual-task walking on
      improving cognitive function (memory, executive function and attention) in CRC patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Self-report Questionnaire
time frame: Change from baseline cognitive function at 12 months
description: The questionnaire includes 37 items to assess perceived cognitive function
measure: Neuropsychological battery test
time frame: Change from baseline cognitive function at 12 months
description: Three neuropsychological battery tests will be used to assess cognitive function of executive function.
measure: Neuropsychological battery test
time frame: Change from baseline cognitive function at 12 months
description: One neuropsychological battery test will be used to assess cognitive function of attention
measure: Neuropsychological battery test
time frame: Change from baseline cognitive function at 12 months
description: Five neuropsychological battery tests will be used to assess cognitive function of memory
measure: Self-report Questionnaire
time frame: Change from baseline symptom at 12 months
description: The questionnaire includes 24 items to assess symptom severity
measure: Self-report Questionnaire
time frame: Change from baseline fatigue at 12 months
description: The questionnaire includes 15 items to assess fatigue level
measure: Self-report Questionnaire
time frame: Change from baseline depression symptom at 12 months
description: The questionnaire includes 20 items to assess frequency of depression symptom
arm group label: Experimental group
arm group type: Experimental
description: Participants in the experimental group will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.
arm group label: Control group
arm group type: No Intervention
description: Participants in control group will receive usual care.
intervention type: Behavioral
intervention name: dual-task walking
description: Participants will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shiow-Ching Shun, PHD
role: Study Chair
affiliation: National Taiwan University
last name: Shiow-Ching Shun, PHD
phone: 886-2-23123456
phone ext: 88439
email: scshun@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Undecided