<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/NCT04407013</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0304</org_study_id>
    <nct_id>NCT04407013</nct_id>
  </id_info>
  <brief_title>Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway</brief_title>
  <official_title>Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to evaluate the efficacy of the standardized care pathway which&#xD;
      provides enhanced supportive care for patients with advanced cancer.&#xD;
&#xD;
      A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of&#xD;
      applying standardized care pathway to provide enhanced supportive care. A Randomized&#xD;
      Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to&#xD;
      intervention arm (receiving enhanced supportive care according to the standardized care&#xD;
      pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the&#xD;
      intervention arm will receive enhanced supportive care consisted of symptom management and&#xD;
      coping enhancement counseling for 5 times. Data from advanced cancer patients will be&#xD;
      collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm),&#xD;
      at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers&#xD;
      will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as&#xD;
      advanced cancer patients' symptom, coping and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)</measure>
    <time_frame>at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Coping measured by brief COPE</measure>
    <time_frame>at the visit for cycle 5 of chemotherapy (at average 3 month)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life measured by the EORTC QLQ C-30</measure>
    <time_frame>at the visit for cycle 5 of chemotherapy (at average 3 month)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation</measure>
    <time_frame>at the visit for cycle 5 of chemotherapy (at average 3 month)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation</measure>
    <time_frame>at 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver</measure>
    <time_frame>at the visit for cycle 5 of chemotherapy (at average 3 month)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver</measure>
    <time_frame>at 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy measured by the Cancer Behavior Inventory 3.0</measure>
    <time_frame>at the visit for cycle 5 of chemotherapy (at average 3 month)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy measured by the Cancer Behavior Inventory 3.0</measure>
    <time_frame>at 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>at 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>at 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)</measure>
    <time_frame>at 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping measured by brief COPE</measure>
    <time_frame>at 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by the EORTC QLQ C-30</measure>
    <time_frame>at 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month</measure>
    <time_frame>At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month</measure>
    <time_frame>At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">780</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group with application of the standardized care pathways and symptom management education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control group with usual care (symptom monitoring only)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced supportive care based on standardized care pathway</intervention_name>
    <description>Enhanced supportive care based on standard care pathway is consisted of 1) symptom management (symptom assessment and according management) and 2) coping enhancement (nurse-led counseling). The enhanced supportive care will be provided 5 times, according to the standardized care pathway.</description>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group with usual care</intervention_name>
    <description>Control group will receive usual care (symptom monitoring only)</description>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult (age &gt;=19 years old),&#xD;
&#xD;
          -  cancer patients and their family&#xD;
&#xD;
          -  ECOG =&lt;2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with cognitive or psychiatric issue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jiyeon Lee, Ph.D</last_name>
    <phone>82-2-2228-3255</phone>
    <email>jiyeonest@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiyeon Lee, Ph.D</last_name>
      <phone>82-2-2228-3255</phone>
      <email>jiyeonest@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</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>Neoplasms</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/NCT04407013
org study id: 4-2020-0304
nct id: NCT04407013
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of the standardized care pathway which
      provides enhanced supportive care for patients with advanced cancer.

      A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of
      applying standardized care pathway to provide enhanced supportive care. A Randomized
      Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to
      intervention arm (receiving enhanced supportive care according to the standardized care
      pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the
      intervention arm will receive enhanced supportive care consisted of symptom management and
      coping enhancement counseling for 5 times. Data from advanced cancer patients will be
      collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm),
      at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers
      will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as
      advanced cancer patients' symptom, coping and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
time frame: at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)
measure: Coping measured by brief COPE
time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Quality of life measured by the EORTC QLQ C-30
time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
time frame: at 6 month
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
time frame: at 6 month
measure: Self-efficacy measured by the Cancer Behavior Inventory 3.0
time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Self-efficacy measured by the Cancer Behavior Inventory 3.0
time frame: at 6 month
measure: Survival
time frame: at 6 month
measure: Survival
time frame: at 12 month
measure: Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
time frame: at 6 month
measure: Coping measured by brief COPE
time frame: at 6 month
measure: Quality of life measured by the EORTC QLQ C-30
time frame: at 6 month
measure: Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month
time frame: At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
measure: Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month
time frame: At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
arm group label: A
arm group type: Experimental
description: Experimental group with application of the standardized care pathways and symptom management education
arm group label: B
arm group type: Other
description: Control group with usual care (symptom monitoring only)
intervention type: Other
intervention name: Enhanced supportive care based on standardized care pathway
description: Enhanced supportive care based on standard care pathway is consisted of 1) symptom management (symptom assessment and according management) and 2) coping enhancement (nurse-led counseling). The enhanced supportive care will be provided 5 times, according to the standardized care pathway.
arm group label: A
intervention type: Other
intervention name: Control group with usual care
description: Control group will receive usual care (symptom monitoring only)
arm group label: B
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jiyeon Lee, Ph.D
phone: 82-2-2228-3255
email: jiyeonest@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No