<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/NCT03252678</url>
  </required_header>
  <id_info>
    <org_study_id>HC15C1391-3</org_study_id>
    <nct_id>NCT03252678</nct_id>
  </id_info>
  <brief_title>Efficacy of Self-education Program for Advanced Care Planning(RCT)</brief_title>
  <official_title>Efficacy of Self-education Program for Advanced Care Planning: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Health, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Clinical Research Coordination Center, Seoul, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ewha Womans University Mokdong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gangneung Asan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daegu Fatima Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Evidence-Based Healthcare Collaborating Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pohang Semyeong Christianity Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</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>
      This study verifies efficacy of Self-education program for advanced care planning. Half of&#xD;
      participants will receive a book and videos about advanced care planning while the other half&#xD;
      will receive a book and videos about pain control for cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study validates effectiveness of educational materials that the investigators developed&#xD;
      due to the rates of completing advanced care planning are considerably low and patients&#xD;
      relatively less less preferred to receive palliative care and hospice at terminal status,&#xD;
      which is led by the lack of information available to patients; whether these decision aids&#xD;
      change end-of-life care preference, elevate the preference of patients toward advanced care&#xD;
      planning, reduce the burden of decision making compare to educational resources that are&#xD;
      currently available.&#xD;
&#xD;
      Previous studies inform that educational video about advanced care planning increases the&#xD;
      knowledge of care for life prolongation, and affects the preference towards care for life&#xD;
      prolongation and palliative care. However, being no resources are provided and orally&#xD;
      explained, patients in the control group don't have enough time to fully aware of the&#xD;
      information, also, since those studies are done mostly in the western countries, 'discussing&#xD;
      with family members or guardians' part is missing, which is critical under contemporary&#xD;
      Korean medical society. This study provides educational resources to both the intervention&#xD;
      group and the control group and identifies if advanced care planning is discussed with family&#xD;
      members or guardians.&#xD;
&#xD;
      Primary outcome of this study is end-of-life care preference. Participants of this study will&#xD;
      fill out the baseline questionnaire about end-of-life care preference, end-of-life discussion&#xD;
      and documentation, knowledge of ACP, etc. After that, participants will be allocated equally&#xD;
      into the intervention group and the control group. The intervention group will receive a book&#xD;
      and videos about advanced care planning which are based on Smart Management Strategy for&#xD;
      Health(SMASH). The control group will receive a book and videos about pain control for cancer&#xD;
      patients that were provided by Korea National Cancer Center. After reading and watching the&#xD;
      educational materials, patients will get another questionnaire about knowledge of ACP,&#xD;
      satisfaction on the materials, end-of-life care preference, and decision role preference.&#xD;
      Participants will read and watch the materials for about 6-8 weeks and then they will be&#xD;
      asked to complete another questionnaire which includes every questions from the baseline and&#xD;
      post-intervention. The result from all three questionnaires (baseline, post-intervention,&#xD;
      7-week questionnaire) will be compiled and be compared with one another.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 21, 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in End-of-life Care Preference</measure>
    <time_frame>Baseline, within 1 week, 7 weeks</time_frame>
    <description>Comparison the result of End-of-life Care Preference questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Hospital Anxiety and Depression Scale</measure>
    <time_frame>Baseline, 7 weeks</time_frame>
    <description>Comparison the result of Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Decision Conflict</measure>
    <time_frame>Baseline, 7 weeks</time_frame>
    <description>Comparison the result of decision conflict questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in EOL care Discussion and Documentation</measure>
    <time_frame>Baseline, 7 weeks</time_frame>
    <description>Comparison the result of EOL care Discussion and Documentation questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Satisfaction on educational materials</measure>
    <time_frame>Baseline, 7 weeks</time_frame>
    <description>Comparison Satisfaction on educational materials questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Decisional Role Preference</measure>
    <time_frame>Baseline, 7 weeks</time_frame>
    <description>Comparison the result of decisional role preference questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Knowledge of CPR</measure>
    <time_frame>Baseline, 7 weeks</time_frame>
    <description>Comparison the result of knowledge of CPR questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intention to document advance care planning</measure>
    <time_frame>Baseline, 7 weeks</time_frame>
    <description>Comparison the result of advance care planning questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>A Book and Videos about ACP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in experimental group get a book of 45 pages and three videos about advanced care planning based on Smart Management Strategy for Health (SMASH). After they finish reading and watching the materials, they fill out the questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A Book and Videos about Pain Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the group get a book and two videos about pain control for cancer patients. After they finish reading and watching the materials, they fill out the questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>a book and videos about ACP</intervention_name>
    <description>A book and three videos about advanced care planning are provided for self-education</description>
    <arm_group_label>A Book and Videos about ACP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>a book and videos about pain control</intervention_name>
    <description>A book and three videos about pain control for cancer patients are provided for self-education</description>
    <arm_group_label>A Book and Videos about Pain Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject 20 years old and more&#xD;
&#xD;
          -  Subject who understands the purpose of the study and signs with informed consent form&#xD;
&#xD;
          -  Subject with advanced cancer&#xD;
&#xD;
          -  Subject who knows he/she is diagnosed with advanced cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak, understand, or write Korean&#xD;
&#xD;
          -  Inability to understand the contents of the provided materials due to poor eyesight&#xD;
             and hearing&#xD;
&#xD;
          -  Medical conditions that would limit adherence to participation of the clinical trial&#xD;
             (as confirmed by their referring physician; e.g. dyspnea, depression and other mental&#xD;
             disorders)&#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>Young Ho Yun, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Young Ho Yun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Advanced Care Planning</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/NCT03252678
org study id: HC15C1391-3
nct id: NCT03252678
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study verifies efficacy of Self-education program for advanced care planning. Half of
      participants will receive a book and videos about advanced care planning while the other half
      will receive a book and videos about pain control for cancer patients.
This study validates effectiveness of educational materials that the investigators developed
      due to the rates of completing advanced care planning are considerably low and patients
      relatively less less preferred to receive palliative care and hospice at terminal status,
      which is led by the lack of information available to patients; whether these decision aids
      change end-of-life care preference, elevate the preference of patients toward advanced care
      planning, reduce the burden of decision making compare to educational resources that are
      currently available.

      Previous studies inform that educational video about advanced care planning increases the
      knowledge of care for life prolongation, and affects the preference towards care for life
      prolongation and palliative care. However, being no resources are provided and orally
      explained, patients in the control group don't have enough time to fully aware of the
      information, also, since those studies are done mostly in the western countries, 'discussing
      with family members or guardians' part is missing, which is critical under contemporary
      Korean medical society. This study provides educational resources to both the intervention
      group and the control group and identifies if advanced care planning is discussed with family
      members or guardians.

      Primary outcome of this study is end-of-life care preference. Participants of this study will
      fill out the baseline questionnaire about end-of-life care preference, end-of-life discussion
      and documentation, knowledge of ACP, etc. After that, participants will be allocated equally
      into the intervention group and the control group. The intervention group will receive a book
      and videos about advanced care planning which are based on Smart Management Strategy for
      Health(SMASH). The control group will receive a book and videos about pain control for cancer
      patients that were provided by Korea National Cancer Center. After reading and watching the
      educational materials, patients will get another questionnaire about knowledge of ACP,
      satisfaction on the materials, end-of-life care preference, and decision role preference.
      Participants will read and watch the materials for about 6-8 weeks and then they will be
      asked to complete another questionnaire which includes every questions from the baseline and
      post-intervention. The result from all three questionnaires (baseline, post-intervention,
      7-week questionnaire) will be compiled and be compared with one another.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Changes in End-of-life Care Preference
time frame: Baseline, within 1 week, 7 weeks
description: Comparison the result of End-of-life Care Preference questionnaire
measure: Changes in Hospital Anxiety and Depression Scale
time frame: Baseline, 7 weeks
description: Comparison the result of Hospital Anxiety and Depression Scale
measure: Changes in Decision Conflict
time frame: Baseline, 7 weeks
description: Comparison the result of decision conflict questionnaire
measure: Changes in EOL care Discussion and Documentation
time frame: Baseline, 7 weeks
description: Comparison the result of EOL care Discussion and Documentation questionnaire
measure: Changes in Satisfaction on educational materials
time frame: Baseline, 7 weeks
description: Comparison Satisfaction on educational materials questionnaire
measure: Changes in Decisional Role Preference
time frame: Baseline, 7 weeks
description: Comparison the result of decisional role preference questionnaire
measure: Changes in Knowledge of CPR
time frame: Baseline, 7 weeks
description: Comparison the result of knowledge of CPR questionnaire
measure: Intention to document advance care planning
time frame: Baseline, 7 weeks
description: Comparison the result of advance care planning questionnaire
arm group label: A Book and Videos about ACP
arm group type: Experimental
description: Subjects in experimental group get a book of 45 pages and three videos about advanced care planning based on Smart Management Strategy for Health (SMASH). After they finish reading and watching the materials, they fill out the questionnaire.
arm group label: A Book and Videos about Pain Control
arm group type: Active Comparator
description: Subjects in the group get a book and two videos about pain control for cancer patients. After they finish reading and watching the materials, they fill out the questionnaire.
intervention type: Other
intervention name: a book and videos about ACP
description: A book and three videos about advanced care planning are provided for self-education
arm group label: A Book and Videos about ACP
intervention type: Other
intervention name: a book and videos about pain control
description: A book and three videos about pain control for cancer patients are provided for self-education
arm group label: A Book and Videos about Pain Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Young Ho Yun, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Young Ho Yun
investigator title: Principal Investigator