<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/NCT02986152</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00075411</org_study_id>
    <nct_id>NCT02986152</nct_id>
  </id_info>
  <brief_title>Cancer Distress Coach Mobile App Trial</brief_title>
  <official_title>Cancer Distress Coach Mobile App Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke Institute for Health Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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 Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic&#xD;
      stress disorder (PTSD) in cancer patients and caregivers. Based largely on &quot;PTSD Coach&quot; from&#xD;
      the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms&#xD;
      and is tailored specifically to individuals impacted by cancer.&#xD;
&#xD;
      This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a&#xD;
      randomized controlled trial (RCT) where subjects are placed into either the intervention&#xD;
      group or the wait-listed control group for a period of 8 weeks. The CDC app is available as a&#xD;
      free download on the App Store® and on Google Play™.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">April 13, 2019</completion_date>
  <primary_completion_date type="Actual">April 13, 2019</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>Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)</measure>
    <time_frame>Baseline, Week 4, Week 8</time_frame>
    <description>The PCL-5 is a 20-item self-report symptom checklist that closely mirrors DSM-5 diagnoses criteria. The instructions will be modified so that symptoms are keyed to the particular traumatic stressor of interest; specifically, subjects will be asked to rate each PTSD symptom in the past 4 weeks with respect to their cancer diagnosis and treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in distress level as measured by the Distress Thermometer</measure>
    <time_frame>Baseline, Week 4, Week 8</time_frame>
    <description>The Distress Thermometer is used to assess psychosocial distress. It consists of a one-item self-report scale from 0-10, where 0 represents no distress and 10 represents extreme distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stress management self-efficacy as measured by the Self-efficacy questionnaire</measure>
    <time_frame>Baseline, Week 4, Week 8</time_frame>
    <description>The Self-efficacy questionnaire is a 1-item measure of self-efficacy developed by the National Center for PTSD. It rates one's ability to manage the stress of situations reminiscent of the cancer experience on a scale of 0-4, where 0 is not at all able and 4 is extremely able.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility as measured by satisfaction with the Cancer Distress Coach mobile app, as measured by the Feedback questionnaire</measure>
    <time_frame>Week 4, Week 8</time_frame>
    <description>The Feedback questionnaire was developed by the study team to assess perceived helpfulness of the app and user satisfaction with the app. Points are totaled and summed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">569</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>CDC Mobile App Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who are randomized to the CDC mobile app treatment arm will be asked to perform the app's full suite of intervention tools such as learning about PTSD, assessment, finding support, and mind/body exercises (e.g., guided imagery, meditation, and relaxation exercises) over the entire 8-week study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CDC Mobile App Wait-List Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects who are randomized to the CDC mobile app wait-list control arm will be asked to perform only the learning about PTSD, assessment, and finding support activities for the first 4 weeks. Following completion of the Week-4 questionnaires, subjects will then be asked to additionally perform the mind/body exercises (e.g., guided imagery, meditation, and relaxation exercises) for the duration of the 8-week study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cancer Distress Coach Mobile App</intervention_name>
    <description>Cancer Distress Coach is a stand-alone symptom management tool with three basic components. The Learn about Distress module provides psycho-education. The Insights module includes an inspiring Quote of the Day, daily activity planning tips, a graph displaying the user's distress level plotted over time, and assessment feedback. The main action of the application is in the Activities module that provides patients with skills to manage their stress in the moment they experience it. Depending on the severity, the patient is routed to any of a number of helpful skills based on cognitive-behavioral principles. The stress management tools include positive imageries, soothing songs and pictures, and the Relax-Identify-Decide tool. Also included is &quot;find support&quot; and &quot;get support now&quot; to connect the user to his/her support network and locate informal cancer and non-cancer related support or (immediate) professional care.</description>
    <arm_group_label>CDC Mobile App Treatment</arm_group_label>
    <arm_group_label>CDC Mobile App Wait-List Control</arm_group_label>
    <other_name>CDC Mobile App</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been diagnosed with cancer or are/were a caregiver to someone with cancer&#xD;
&#xD;
          -  Resident of the United States of America&#xD;
&#xD;
          -  Able to read and write English&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophia K Smith, PhD, MSW</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>anxiety</keyword>
  <keyword>depression</keyword>
  <keyword>distress</keyword>
  <keyword>fear</keyword>
  <keyword>coping</keyword>
  <keyword>support</keyword>
  <keyword>caregiver</keyword>
  <keyword>oncology</keyword>
  <keyword>app</keyword>
  <keyword>mobile app</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT02986152
org study id: Pro00075411
nct id: NCT02986152
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic
      stress disorder (PTSD) in cancer patients and caregivers. Based largely on "PTSD Coach" from
      the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms
      and is tailored specifically to individuals impacted by cancer.

      This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a
      randomized controlled trial (RCT) where subjects are placed into either the intervention
      group or the wait-listed control group for a period of 8 weeks. The CDC app is available as a
      free download on the App Store® and on Google Play™.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)
time frame: Baseline, Week 4, Week 8
description: The PCL-5 is a 20-item self-report symptom checklist that closely mirrors DSM-5 diagnoses criteria. The instructions will be modified so that symptoms are keyed to the particular traumatic stressor of interest; specifically, subjects will be asked to rate each PTSD symptom in the past 4 weeks with respect to their cancer diagnosis and treatment.
measure: Change in distress level as measured by the Distress Thermometer
time frame: Baseline, Week 4, Week 8
description: The Distress Thermometer is used to assess psychosocial distress. It consists of a one-item self-report scale from 0-10, where 0 represents no distress and 10 represents extreme distress.
measure: Change in stress management self-efficacy as measured by the Self-efficacy questionnaire
time frame: Baseline, Week 4, Week 8
description: The Self-efficacy questionnaire is a 1-item measure of self-efficacy developed by the National Center for PTSD. It rates one's ability to manage the stress of situations reminiscent of the cancer experience on a scale of 0-4, where 0 is not at all able and 4 is extremely able.
measure: Feasibility as measured by satisfaction with the Cancer Distress Coach mobile app, as measured by the Feedback questionnaire
time frame: Week 4, Week 8
description: The Feedback questionnaire was developed by the study team to assess perceived helpfulness of the app and user satisfaction with the app. Points are totaled and summed.
arm group label: CDC Mobile App Treatment
arm group type: Experimental
description: Subjects who are randomized to the CDC mobile app treatment arm will be asked to perform the app's full suite of intervention tools such as learning about PTSD, assessment, finding support, and mind/body exercises (e.g., guided imagery, meditation, and relaxation exercises) over the entire 8-week study period.
arm group label: CDC Mobile App Wait-List Control
arm group type: Other
description: Subjects who are randomized to the CDC mobile app wait-list control arm will be asked to perform only the learning about PTSD, assessment, and finding support activities for the first 4 weeks. Following completion of the Week-4 questionnaires, subjects will then be asked to additionally perform the mind/body exercises (e.g., guided imagery, meditation, and relaxation exercises) for the duration of the 8-week study period.
intervention type: Behavioral
intervention name: Cancer Distress Coach Mobile App
description: Cancer Distress Coach is a stand-alone symptom management tool with three basic components. The Learn about Distress module provides psycho-education. The Insights module includes an inspiring Quote of the Day, daily activity planning tips, a graph displaying the user's distress level plotted over time, and assessment feedback. The main action of the application is in the Activities module that provides patients with skills to manage their stress in the moment they experience it. Depending on the severity, the patient is routed to any of a number of helpful skills based on cognitive-behavioral principles. The stress management tools include positive imageries, soothing songs and pictures, and the Relax-Identify-Decide tool. Also included is "find support" and "get support now" to connect the user to his/her support network and locate informal cancer and non-cancer related support or (immediate) professional care.
arm group label: CDC Mobile App Treatment
arm group label: CDC Mobile App Wait-List Control
other name: CDC Mobile App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophia K Smith, PhD, MSW
role: Principal Investigator
affiliation: Duke University School of Nursing
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No