<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/NCT03783481</url>
  </required_header>
  <id_info>
    <org_study_id>S2018-2450-0001</org_study_id>
    <nct_id>NCT03783481</nct_id>
  </id_info>
  <brief_title>Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology</brief_title>
  <acronym>DRAAGON</acronym>
  <official_title>Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</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>
      This study aims to investigate the effect of the formation of social networks using&#xD;
      smartphones can help increase physical activity and reduce stress in survivors after breast&#xD;
      cancer treatment surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">November 16, 2020</completion_date>
  <primary_completion_date type="Actual">April 17, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of moderate to severe distress at 6 months</measure>
    <time_frame>6months</time_frame>
    <description>Using distress thermometer collected by smartphone application based questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total weekly steps at 6 months</measure>
    <time_frame>6months</time_frame>
    <description>the total number of weekly steps collected by smartphone application</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Mobile Community</condition>
  <arm_group>
    <arm_group_label>Mobile community group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>join the mobile community via the smartphone application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No community group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile community</intervention_name>
    <description>Install an application (app) on subjects' smartphone. Subject's will join the mobile community using the application through which they can check their own and other members daily steps and communicate with each other.</description>
    <arm_group_label>Mobile community group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Mobile community</intervention_name>
    <description>No Mobile community</description>
    <arm_group_label>No community group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 0-III breast cancer&#xD;
&#xD;
          -  ECOG Performance Status 0&#xD;
&#xD;
          -  Patient who underwent surgery for breast cancer&#xD;
&#xD;
          -  Patients with their own smartphones and who can use smartphone apps&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breast cancer recurrence or metastasis&#xD;
&#xD;
          -  Severe medical illness&#xD;
&#xD;
          -  need to Adjubant Chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Il Yong Chung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Korea</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Il Yong Chung</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast cancer survivors</keyword>
  <keyword>mobile community</keyword>
  <keyword>distress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT03783481
org study id: S2018-2450-0001
nct id: NCT03783481
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the effect of the formation of social networks using
      smartphones can help increase physical activity and reduce stress in survivors after breast
      cancer treatment surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of moderate to severe distress at 6 months
time frame: 6months
description: Using distress thermometer collected by smartphone application based questionnaire
measure: total weekly steps at 6 months
time frame: 6months
description: the total number of weekly steps collected by smartphone application
arm group label: Mobile community group
arm group type: Experimental
description: join the mobile community via the smartphone application
arm group label: No community group
arm group type: Active Comparator
intervention type: Device
intervention name: Mobile community
description: Install an application (app) on subjects' smartphone. Subject's will join the mobile community using the application through which they can check their own and other members daily steps and communicate with each other.
arm group label: Mobile community group
intervention type: Other
intervention name: No Mobile community
description: No Mobile community
arm group label: No community group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Il Yong Chung
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Il Yong Chung
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: No