<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/NCT03242200</url>
  </required_header>
  <id_info>
    <org_study_id>J1734</org_study_id>
    <secondary_id>IRB00126543</secondary_id>
    <nct_id>NCT03242200</nct_id>
  </id_info>
  <brief_title>Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer</brief_title>
  <official_title>Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Villanova University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oncology Nursing Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</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 purpose of this research study is to understand if a mobile app is useful to assist young&#xD;
      adult female survivors of childhood cancer in the self-management of survivorship-related&#xD;
      needs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Survivorship related needs include managing lingering symptoms from treatment, how to keep a&#xD;
      healthy lifestyle, social and medical issues, as well as other needs. The mobile health app&#xD;
      that will be used in this study is the Health Storylines TM app developed by Self Care&#xD;
      Catalysts Inc. The app can be used for an unlimited amount of time over nine months, which is&#xD;
      how long the study will be conducted. The use of the Health Storylines TM app in this study&#xD;
      is investigational.&#xD;
&#xD;
      Participation in this study starts with setting up a study specific profile on the app and&#xD;
      entering information including email address, age, ethnicity/race, cancer diagnosis, as well&#xD;
      as other optional information for the profile (example health goals or current health&#xD;
      conditions). Participants will then be prompted by the app to complete three questionnaires&#xD;
      about their ability to self-manage their survivorship-related needs, their perception of&#xD;
      their survivorship-related illness symptoms and perceived health related quality of life.&#xD;
      They will be prompted on the app to complete these questionnaires again at the 3, 6 and 9&#xD;
      month intervals of using the app. It will take about 20 minutes to complete the&#xD;
      questionnaires at each measurement time. The only additional information that will be&#xD;
      reported from the app for the study is the amount of time and features of programs accessed&#xD;
      during the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">March 11, 2021</completion_date>
  <primary_completion_date type="Actual">March 11, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This project is a longitudinal one-group pilot study evaluating the use of a Mobile Health (mHealth) app intervention. This study will examine: 1) the amount/type of usage, 2 ) compliance with study evaluations and 3) the association of this mHealth app use with perceived self-efficacy in managing survivorship related needs, perceived health illness and health related quality of life. The study period will be nine months, with four measurement points to assess the study's outcomes: baseline, three, six, and nine months post initiation of the mHealth app.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of mHealth app as measured by tracking all activities conducted on the app</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Assess the feasibility of the mHealth app as measured by tracking all activities of the patient-centered mHealth health tracking app, Health StorylinesTM, in young adult female survivors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Assess the adherence to study procedures including baseline and follow-up assessments as measured by completion rates of required tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app, and self-efficacy in young adult female survivors of childhood cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and health related quality of life in young adult female survivors of childhood cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Illness</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and perceived illness in young adult female survivors of childhood cancer.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Childhood Cancer Survivor</condition>
  <arm_group>
    <arm_group_label>Mobile Health App</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will be prompted to complete questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Health App</intervention_name>
    <description>Mobile Health is a multi-featured app designed to enable participants to self-record and track their health and wellness. Participations will set up a profile and complete questionnaires. The app also records the amount of time and features of programs accessed.</description>
    <arm_group_label>Mobile Health App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria are females who:&#xD;
&#xD;
          -  Have been diagnosed with cancer before the age of 18 years&#xD;
&#xD;
          -  Are between the ages 18 to 30 years&#xD;
&#xD;
          -  Have been off treatment for at least six months&#xD;
&#xD;
          -  Have a personal smart device to use for the app&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female survivors of childhood cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathy Ruble, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.selfcarecatalysts.com/</url>
    <description>Self Care Catalysts</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>survivors of childhood cancer</keyword>
  <keyword>young adult female</keyword>
  <keyword>mobile app</keyword>
  <keyword>questionnaire</keyword>
  <keyword>health tracking</keyword>
  <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/NCT03242200
org study id: J1734
secondary id: IRB00126543
nct id: NCT03242200
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to understand if a mobile app is useful to assist young
      adult female survivors of childhood cancer in the self-management of survivorship-related
      needs.
Survivorship related needs include managing lingering symptoms from treatment, how to keep a
      healthy lifestyle, social and medical issues, as well as other needs. The mobile health app
      that will be used in this study is the Health Storylines TM app developed by Self Care
      Catalysts Inc. The app can be used for an unlimited amount of time over nine months, which is
      how long the study will be conducted. The use of the Health Storylines TM app in this study
      is investigational.

      Participation in this study starts with setting up a study specific profile on the app and
      entering information including email address, age, ethnicity/race, cancer diagnosis, as well
      as other optional information for the profile (example health goals or current health
      conditions). Participants will then be prompted by the app to complete three questionnaires
      about their ability to self-manage their survivorship-related needs, their perception of
      their survivorship-related illness symptoms and perceived health related quality of life.
      They will be prompted on the app to complete these questionnaires again at the 3, 6 and 9
      month intervals of using the app. It will take about 20 minutes to complete the
      questionnaires at each measurement time. The only additional information that will be
      reported from the app for the study is the amount of time and features of programs accessed
      during the study period.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This project is a longitudinal one-group pilot study evaluating the use of a Mobile Health (mHealth) app intervention. This study will examine: 1) the amount/type of usage, 2 ) compliance with study evaluations and 3) the association of this mHealth app use with perceived self-efficacy in managing survivorship related needs, perceived health illness and health related quality of life. The study period will be nine months, with four measurement points to assess the study's outcomes: baseline, three, six, and nine months post initiation of the mHealth app.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of mHealth app as measured by tracking all activities conducted on the app
time frame: Up to 2 years
description: Assess the feasibility of the mHealth app as measured by tracking all activities of the patient-centered mHealth health tracking app, Health StorylinesTM, in young adult female survivors
measure: Adherence
time frame: Up to 2 years
description: Assess the adherence to study procedures including baseline and follow-up assessments as measured by completion rates of required tasks
measure: Self-Efficacy
time frame: Up to 2 years
description: Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app, and self-efficacy in young adult female survivors of childhood cancer.
measure: Health Related Quality of Life
time frame: Up to 2 years
description: Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and health related quality of life in young adult female survivors of childhood cancer
measure: Perceived Illness
time frame: Up to 2 years
description: Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and perceived illness in young adult female survivors of childhood cancer.
arm group label: Mobile Health App
arm group type: Other
description: Participants will be prompted to complete questionnaires.
intervention type: Other
intervention name: Mobile Health App
description: Mobile Health is a multi-featured app designed to enable participants to self-record and track their health and wellness. Participations will set up a profile and complete questionnaires. The app also records the amount of time and features of programs accessed.
arm group label: Mobile Health App
criteria: 
gender: Female
gender based: Yes
gender description: Female survivors of childhood cancer
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathy Ruble, RN, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
url: http://www.selfcarecatalysts.com/
description: Self Care Catalysts
responsible party type: Sponsor
sharing ipd: No