<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/NCT02999529</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00085515</org_study_id>
    <nct_id>NCT02999529</nct_id>
  </id_info>
  <brief_title>Health Literacy Multi-media Study</brief_title>
  <official_title>Improving Patient Understanding of Key Terms Used to Describe Chemotherapy and Its Side Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer patients are presented with a lot of information about their diagnosis and different&#xD;
      treatment options, which can be confusing. The purpose of this study is to see if a simple&#xD;
      video explanation of six words used to describe cancer treatment improves patient&#xD;
      understanding of these words.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer patients are presented with a lot of information about their diagnosis and different&#xD;
      treatment options, which can be confusing. The purpose of this study is to see if a simple&#xD;
      video explanation of six words used to describe cancer treatment improves patient&#xD;
      understanding of these words.&#xD;
&#xD;
      Participants will be interviewed and asked the meaning of six words related to cancer&#xD;
      treatment. Following the interview, participants will be shown a video about the meaning of&#xD;
      the words. After viewing the video, participants will be re-interviewed to test how effective&#xD;
      the video was at explaining the six words.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Correct Responses</measure>
    <time_frame>Post Intervention (Up to ten minutes)</time_frame>
    <description>The number of correct responses to the meaning of the six cancer treatment words will be collected after watching the educational video.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Incorrect Responses</measure>
    <time_frame>Post Intervention (Up to ten minutes)</time_frame>
    <description>The number of incorrect responses to the meaning of the six cancer treatment words will be collected after watching the educational video.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Education Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants offered a consent for chemotherapy treatment will watch an educational video.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Video</intervention_name>
    <description>Participants will be asked if they know the meaning of six words related to cancer treatment. Following the interview, participants will watch a video explaining the meaning of the six words. After viewing the video, participants will be re-interviewed about the meaning of the six words.</description>
    <arm_group_label>Education Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at Grady Memorial Hospital who is offered a consent to receive chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Profession as a physician or nurse&#xD;
&#xD;
          -  Non English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca Pentz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>May 16, 2017</last_update_submitted>
  <last_update_submitted_qc>May 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Rebecca D. Pentz, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Chemotherapy</keyword>
  <keyword>Oncology</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/NCT02999529
org study id: IRB00085515
nct id: NCT02999529
lead sponsor: 
has dmc: No
Cancer patients are presented with a lot of information about their diagnosis and different
      treatment options, which can be confusing. The purpose of this study is to see if a simple
      video explanation of six words used to describe cancer treatment improves patient
      understanding of these words.
Cancer patients are presented with a lot of information about their diagnosis and different
      treatment options, which can be confusing. The purpose of this study is to see if a simple
      video explanation of six words used to describe cancer treatment improves patient
      understanding of these words.

      Participants will be interviewed and asked the meaning of six words related to cancer
      treatment. Following the interview, participants will be shown a video about the meaning of
      the words. After viewing the video, participants will be re-interviewed to test how effective
      the video was at explaining the six words.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Correct Responses
time frame: Post Intervention (Up to ten minutes)
description: The number of correct responses to the meaning of the six cancer treatment words will be collected after watching the educational video.
measure: Number of Incorrect Responses
time frame: Post Intervention (Up to ten minutes)
description: The number of incorrect responses to the meaning of the six cancer treatment words will be collected after watching the educational video.
arm group label: Education Group
arm group type: Experimental
description: Participants offered a consent for chemotherapy treatment will watch an educational video.
intervention type: Other
intervention name: Educational Video
description: Participants will be asked if they know the meaning of six words related to cancer treatment. Following the interview, participants will watch a video explaining the meaning of the six words. After viewing the video, participants will be re-interviewed about the meaning of the six words.
arm group label: Education Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Rebecca Pentz, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Rebecca D. Pentz, PhD
investigator title: Professor