<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/NCT03277235</url>
  </required_header>
  <id_info>
    <org_study_id>201612224RIND</org_study_id>
    <nct_id>NCT03277235</nct_id>
  </id_info>
  <brief_title>Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients</brief_title>
  <official_title>Effect of a Resilience Model-Based Care Plan in Reducing Fear of Recurrence and GI Symptom Distress and Improving Quality of Life in Newly Diagnosed Colorectal Cancer Patients</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 the protective and risk factors of&#xD;
      resilience in colorectal cancer patients, and examine the effect of the resilience&#xD;
      model-based care plan in reducing fear of recurrence and GI symptom distress and improving&#xD;
      quality of life in newly diagnosed colorectal cancer (CRC) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Develop and evaluate the effect of a resilience model-based total care plan on reducing fear&#xD;
      of recurrence and GI symptom distress and improving quality of life (QOL) in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-report Questionnaire</measure>
    <time_frame>Change from baseline fear of cancer recurrence at 12 months</time_frame>
    <description>The questionnaire includes 42 items to assess fear of cancer recurrence</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-report Questionnaire</measure>
    <time_frame>Change from baseline quality of life at 12 months</time_frame>
    <description>The questionnaire includes 7 items to assess quality of life</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Resilience model-based total care plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-week care plan with 5 times face-to-face intervention and weekly phone call follow-up to increase the protective factors (positive thinking. problem-solving, finding meaning, and social connection) and decrease the risk factors (disease-related distress and defense coping) of resilience</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resilience model-based total care plan</intervention_name>
    <description>12-week care plan with 5 times face-to-face intervention and weekly phone call follow-up to increase the protective factors (positive thinking. problem-solving, finding meaning, and social connection) and decrease the risk factors (disease-related distress and defense coping) of resilience</description>
    <arm_group_label>Resilience model-based total care plan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with stage I to III colon cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with cancer other than colon cancer or have cancer recurrence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</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>
    <contact>
      <last_name>Shiow-Ching Shun, PHD</last_name>
      <phone>86-2-2312-3456</phone>
      <phone_ext>88439</phone_ext>
      <email>scshun@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fatigue</keyword>
  <keyword>colon cancer</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT03277235
org study id: 201612224RIND
nct id: NCT03277235
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 the protective and risk factors of
      resilience in colorectal cancer patients, and examine the effect of the resilience
      model-based care plan in reducing fear of recurrence and GI symptom distress and improving
      quality of life in newly diagnosed colorectal cancer (CRC) patients.
Develop and evaluate the effect of a resilience model-based total care plan on reducing fear
      of recurrence and GI symptom distress and improving quality of life (QOL) in this population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
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 fear of cancer recurrence at 12 months
description: The questionnaire includes 42 items to assess fear of cancer recurrence
measure: Self-report Questionnaire
time frame: Change from baseline quality of life at 12 months
description: The questionnaire includes 7 items to assess quality of life
arm group label: Resilience model-based total care plan
arm group type: Experimental
description: 12-week care plan with 5 times face-to-face intervention and weekly phone call follow-up to increase the protective factors (positive thinking. problem-solving, finding meaning, and social connection) and decrease the risk factors (disease-related distress and defense coping) of resilience
arm group label: Control
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: Resilience model-based total care plan
description: 12-week care plan with 5 times face-to-face intervention and weekly phone call follow-up to increase the protective factors (positive thinking. problem-solving, finding meaning, and social connection) and decrease the risk factors (disease-related distress and defense coping) of resilience
arm group label: Resilience model-based total care plan
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
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: 
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: Undecided