<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/NCT03810053</url>
  </required_header>
  <id_info>
    <org_study_id>228815</org_study_id>
    <nct_id>NCT03810053</nct_id>
  </id_info>
  <brief_title>Utilizing Technology to Promote Cancer Prevention</brief_title>
  <official_title>Utilizing Technology to Promote Cancer Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</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 goal of the program is to develop an online module/a health application for cell phones&#xD;
      which will share didactic information regarding cancer prevention and early detection&#xD;
      measures. These module/application will be developed, and be tested among volunteers for&#xD;
      feedback. In the future, these module/application will be disseminated widely to address&#xD;
      cancer health disparity particularly in Arkansas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The application or the online module will play a short didactic explanation video that will&#xD;
      provide information about cancers and benefits of uptake of cancer prevention and early&#xD;
      detection measures. It is currently unknown which method will be used, the online module or&#xD;
      the application for the purpose. The study participants will be subjected to only one method&#xD;
      (once the method have been finalized and created). The video content will engulf information&#xD;
      about cervical, breast, colorectal and lung cancer prevention and early detection. After the&#xD;
      video, the application or the module will capture information on gender, age, smoking status,&#xD;
      body mass index and positive cancer history in family. Watching the video and answering the&#xD;
      questions will take approximately 5 minutes. The study participants will download the&#xD;
      application on their personal cell phones and the data collected will be linked to&#xD;
      identifying information in case they choose to receive the compensation and opt for the&#xD;
      6-month follow-up. Based on the responses provided, and the age and the gender, the&#xD;
      participants will be provided with a list of cancer prevention and early detection&#xD;
      measure(s). A subset of the study participants from ARResearch (only those who have agreed&#xD;
      for the 6-month follow-up) will be asked if they are willing to be contacted by the study&#xD;
      staff after 6 ±1 months (from the date of enrollment in the study) to enquire if they&#xD;
      received/adopted the screening measures(s) that were suggested based on their age, gender and&#xD;
      family history. They will be asked whether it is OK to call and/or e-mail them for more&#xD;
      information to better describe barriers to obtaining cancer prevention and screening&#xD;
      measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">July 14, 2021</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants to Learn New Information</measure>
    <time_frame>up to 6 Months</time_frame>
    <description>Percentage of participants that indicated they learned something new about cancer prevention measures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants to Identify Needed Interventions</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Percentage of participants that identified interventions that they have not yet adopted from the use of the health application.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">290</enrollment>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Mobile App/Online Module</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile App/Online Module</intervention_name>
    <description>Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.</description>
    <arm_group_label>Mobile App/Online Module</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any ARResearch volunteer&#xD;
&#xD;
          -  18 years or older in age&#xD;
&#xD;
          -  Have access to a personal cell phone and/or computer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give an informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mayumi Nakagawa, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>July 22, 2021</results_first_submitted>
  <results_first_submitted_qc>August 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 22, 2021</results_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03810053/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mobile App/Online Module</title>
          <description>Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.&#xD;
Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="290"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="290"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mobile App/Online Module</title>
          <description>Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.&#xD;
Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="290"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18-29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;/=50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants to Learn New Information</title>
        <description>Percentage of participants that indicated they learned something new about cancer prevention measures.</description>
        <time_frame>up to 6 Months</time_frame>
        <population>290 participants ages 18 and over.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobile App/Online Module</title>
            <description>Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.&#xD;
Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants to Learn New Information</title>
          <description>Percentage of participants that indicated they learned something new about cancer prevention measures.</description>
          <population>290 participants ages 18 and over.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants to Identify Needed Interventions</title>
        <description>Percentage of participants that identified interventions that they have not yet adopted from the use of the health application.</description>
        <time_frame>up to 6 months</time_frame>
        <population>290 participants 18 and over.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobile App/Online Module</title>
            <description>Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.&#xD;
Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants to Identify Needed Interventions</title>
          <description>Percentage of participants that identified interventions that they have not yet adopted from the use of the health application.</description>
          <population>290 participants 18 and over.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</time_frame>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mobile App/Online Module</title>
          <description>Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.&#xD;
Mobile App/Online Module: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Matthew Henry</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>5016868274</phone>
      <email>mhenry3@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03810053
org study id: 228815
nct id: NCT03810053
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the program is to develop an online module/a health application for cell phones
      which will share didactic information regarding cancer prevention and early detection
      measures. These module/application will be developed, and be tested among volunteers for
      feedback. In the future, these module/application will be disseminated widely to address
      cancer health disparity particularly in Arkansas.
The application or the online module will play a short didactic explanation video that will
      provide information about cancers and benefits of uptake of cancer prevention and early
      detection measures. It is currently unknown which method will be used, the online module or
      the application for the purpose. The study participants will be subjected to only one method
      (once the method have been finalized and created). The video content will engulf information
      about cervical, breast, colorectal and lung cancer prevention and early detection. After the
      video, the application or the module will capture information on gender, age, smoking status,
      body mass index and positive cancer history in family. Watching the video and answering the
      questions will take approximately 5 minutes. The study participants will download the
      application on their personal cell phones and the data collected will be linked to
      identifying information in case they choose to receive the compensation and opt for the
      6-month follow-up. Based on the responses provided, and the age and the gender, the
      participants will be provided with a list of cancer prevention and early detection
      measure(s). A subset of the study participants from ARResearch (only those who have agreed
      for the 6-month follow-up) will be asked if they are willing to be contacted by the study
      staff after 6 ±1 months (from the date of enrollment in the study) to enquire if they
      received/adopted the screening measures(s) that were suggested based on their age, gender and
      family history. They will be asked whether it is OK to call and/or e-mail them for more
      information to better describe barriers to obtaining cancer prevention and screening
      measures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percentage of Participants to Learn New Information
time frame: up to 6 Months
description: Percentage of participants that indicated they learned something new about cancer prevention measures.
measure: Percentage of Participants to Identify Needed Interventions
time frame: up to 6 months
description: Percentage of participants that identified interventions that they have not yet adopted from the use of the health application.
arm group label: Mobile App/Online Module
arm group type: Experimental
description: Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.
intervention type: Behavioral
intervention name: Mobile App/Online Module
description: Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.
arm group label: Mobile App/Online Module
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mayumi Nakagawa, Ph.D
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 