<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/NCT03013972</url>
  </required_header>
  <id_info>
    <org_study_id>CRF-CRC01</org_study_id>
    <nct_id>NCT03013972</nct_id>
  </id_info>
  <brief_title>A Longitudinal Study of Cancer-related Fatigue Among Colorectal Cancer Patients During Adjuvant Chemotherapy</brief_title>
  <official_title>A Longitudinal Study of Cancer-related Fatigue Among Colorectal Cancer Patients During Adjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mackay Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients die&#xD;
      from colorectal cancer each year. The third leading cause of death is colorectal cancer in&#xD;
      Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy&#xD;
      and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence.&#xD;
      However, disease and treatment-related toxicities in cancer patients may result in fatigue&#xD;
      and interfered quality of life (QoL). Previous studies have reported that cancer-related&#xD;
      fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases, it&#xD;
      can occur during treatment, in advanced disease and in disease-free survivors; the prevalence&#xD;
      of fatigue is reported to be between 59-96% in patients undergoing chemotherapy, 65-100% in&#xD;
      patients receiving radiation therapy, and 30% in long term survivors. Also, CRF has been&#xD;
      reported as the most frequent and distressing toxicity of colon and rectal chemotherapy. The&#xD;
      National Comprehensive Cancer Network (NCCN) has published guidelines for the definition of&#xD;
      CRF as ''a persistent subjective sense of physical, emotional, and/or cognitive tiredness or&#xD;
      exhaustion related to cancer or cancer treatment that is not proportional to recent activity&#xD;
      and that significantly interferes with usual functioning.&quot; Besides, CRF could dynamically&#xD;
      change with the interactions among disease progression, treatment regimen, tumor site,&#xD;
      nutrition, infection or other factors. Therefore, to minimize the impact of CRF on cancer&#xD;
      patients, more in-depth researches on CRF are needed.&#xD;
&#xD;
      The aim of this longitudinal study is to examine the dynamic changes, correlated factors and&#xD;
      QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the&#xD;
      results will supply physicians with more understanding about CRF, and help them to enhance&#xD;
      the quality on cancer care to being perfected in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll colorectal cancer patients with adjuvant chemotherapy about 1 year&#xD;
      (estimated 60 patients). Brief fatigue inventory-Taiwanese form (BFI-T) and functional&#xD;
      assessment of cancer therapy-general 7 (FACT-G7) will be used to evaluate patients' fatigue&#xD;
      and quality of life. Patients will be thoroughly informed about all aspects of the study&#xD;
      activity schedule and all regulatory requirements that must be satisfied for informed&#xD;
      consent. Only patients who give consent to participate in this study and meet all other&#xD;
      inclusion and exclusion criteria will be eligible to enroll into this study. The&#xD;
      questionnaire survey will be carried out before first chemotherapy treatment (baseline), and&#xD;
      every four chemotherapy cycles (i.e. at cycle 4, 8 and 12) after chemotherapy treatment at&#xD;
      outpatient department (OPD) or ward during adjuvant chemotherapy treatment period. All&#xD;
      patients will receive standard chemotherapy which continued for 24 weeks (12 cycles) or until&#xD;
      disease progression, whichever came first. Subject demographic and disease-related&#xD;
      information will also be collected for analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)</measure>
    <time_frame>Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)</measure>
    <time_frame>Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>ColoRectal Cancer</condition>
  <arm_group>
    <arm_group_label>Colorectal cancer patients</arm_group_label>
    <description>Colorectal cancer patients during adjuvant chemotherapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Colorectal cancer patients during adjuvant chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who signed the informed consent form&#xD;
&#xD;
          2. Aged 20 years and older&#xD;
&#xD;
          3. Patients who have been given a diagnosis of stage II-IV colorectal cancer&#xD;
&#xD;
          4. Scheduled to receive adjuvant chemotherapy&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2&#xD;
&#xD;
          6. Able to communicate verbally and completely fill out the questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female patients are pregnant or breast-feeding&#xD;
&#xD;
          2. Patients have enrolled or have not yet completed other investigational drug trials&#xD;
             within 30 days before screening&#xD;
&#xD;
          3. Patients who have been given a diagnosis of cognitive impairment are unable to&#xD;
             complete the questionnaires&#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>Hsi-Hsien Hsu, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mackay Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsi-Hsien Hsu, M.D., Ph.D.</last_name>
    <phone>886-975-835784</phone>
    <email>hsu5936@ms3.hinet.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mackay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>104</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hsi-Hsien Hsu, M.D., Ph.D.</last_name>
      <phone>886-975-835784</phone>
      <email>hsu5936@ms3.hinet.net</email>
    </contact>
    <investigator>
      <last_name>Hsi-Hsien Hsu, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ming-Jen Chen, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chien-Kuo Liu, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Hsi-Hsien Hsu</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>ColoRectal Cancer</keyword>
  <keyword>Adjuvant Chemotherapy</keyword>
  <keyword>Cancer-related Fatigue</keyword>
  <keyword>Brief fatigue inventory (BFI)</keyword>
  <keyword>Functional Assessment of Cancer Therapy-General 7 (FACT-G7)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03013972
org study id: CRF-CRC01
nct id: NCT03013972
lead sponsor: 
has dmc: No
Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients die
      from colorectal cancer each year. The third leading cause of death is colorectal cancer in
      Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy
      and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence.
      However, disease and treatment-related toxicities in cancer patients may result in fatigue
      and interfered quality of life (QoL). Previous studies have reported that cancer-related
      fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases, it
      can occur during treatment, in advanced disease and in disease-free survivors; the prevalence
      of fatigue is reported to be between 59-96% in patients undergoing chemotherapy, 65-100% in
      patients receiving radiation therapy, and 30% in long term survivors. Also, CRF has been
      reported as the most frequent and distressing toxicity of colon and rectal chemotherapy. The
      National Comprehensive Cancer Network (NCCN) has published guidelines for the definition of
      CRF as ''a persistent subjective sense of physical, emotional, and/or cognitive tiredness or
      exhaustion related to cancer or cancer treatment that is not proportional to recent activity
      and that significantly interferes with usual functioning." Besides, CRF could dynamically
      change with the interactions among disease progression, treatment regimen, tumor site,
      nutrition, infection or other factors. Therefore, to minimize the impact of CRF on cancer
      patients, more in-depth researches on CRF are needed.

      The aim of this longitudinal study is to examine the dynamic changes, correlated factors and
      QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the
      results will supply physicians with more understanding about CRF, and help them to enhance
      the quality on cancer care to being perfected in the future.
This study will enroll colorectal cancer patients with adjuvant chemotherapy about 1 year
      (estimated 60 patients). Brief fatigue inventory-Taiwanese form (BFI-T) and functional
      assessment of cancer therapy-general 7 (FACT-G7) will be used to evaluate patients' fatigue
      and quality of life. Patients will be thoroughly informed about all aspects of the study
      activity schedule and all regulatory requirements that must be satisfied for informed
      consent. Only patients who give consent to participate in this study and meet all other
      inclusion and exclusion criteria will be eligible to enroll into this study. The
      questionnaire survey will be carried out before first chemotherapy treatment (baseline), and
      every four chemotherapy cycles (i.e. at cycle 4, 8 and 12) after chemotherapy treatment at
      outpatient department (OPD) or ward during adjuvant chemotherapy treatment period. All
      patients will receive standard chemotherapy which continued for 24 weeks (12 cycles) or until
      disease progression, whichever came first. Subject demographic and disease-related
      information will also be collected for analysis.
observational model: Cohort
time perspective: Prospective
measure: Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
time frame: Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).
measure: Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
time frame: Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).
arm group label: Colorectal cancer patients
description: Colorectal cancer patients during adjuvant chemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hsi-Hsien Hsu, M.D., Ph.D.
role: Principal Investigator
affiliation: Mackay Memorial Hospital
last name: Hsi-Hsien Hsu, M.D., Ph.D.
phone: 886-975-835784
email: hsu5936@ms3.hinet.net
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Mackay Memorial Hospital
investigator full name: Hsi-Hsien Hsu
investigator title: Attending Physician
mesh term: Colorectal Neoplasms
mesh term: Fatigue
sharing ipd: No