<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/NCT04409782</url>
  </required_header>
  <id_info>
    <org_study_id>D20039</org_study_id>
    <secondary_id>P30CA023108-40S4</secondary_id>
    <nct_id>NCT04409782</nct_id>
  </id_info>
  <brief_title>Education About Health and Cancer Study</brief_title>
  <official_title>Education About Health and Cancer Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dartmouth College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock 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 investigates different ways to educate rural residents living in New Hampshire and&#xD;
      Vermont about cancer research studies and clinical trials to increase knowledge of, increase&#xD;
      positive attitudes toward, and encourage enrollment in cancer research studies and clinical&#xD;
      trials. The information learned from this study will contribute to a nation-wide initiative&#xD;
      to educate the public about clinical trials, including a nation-wide evaluation of that&#xD;
      initiative. The results of this study may also help researchers understand how education&#xD;
      about clinical trials/research affects knowledge of and attitudes toward cancer research and&#xD;
      clinical trials, as well as behavioral intentions and actual behaviors related to enrolling&#xD;
      in cancer research studies and clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study team will implement and evaluate the research study and clinical trials education&#xD;
      in two experimental arms-&#xD;
&#xD;
        1. group education (Aim 1a) and&#xD;
&#xD;
        2. an online format (Aim 1b) The education in both formats will be based on a set of key&#xD;
           messages that cover information about research studies and clinical trials, including&#xD;
           what research studies are, the benefits, the risks, and connection to available research&#xD;
           studies and clinical trials&#xD;
&#xD;
      Experimental Arm 1 (Aim 1a) Implement group education regarding what clinical trials and&#xD;
      cancer research are and evaluate the effect on knowledge of, attitudes and behavioral&#xD;
      intentions toward, and actual enrollment into clinical trials and cancer research studies.&#xD;
&#xD;
      Study team will evaluate group educational sessions regarding what clinical trials and cancer&#xD;
      research studies are. The learning objectives focus on improving participants' knowledge&#xD;
      about what clinical trials and cancer research studies are and how to access trials and&#xD;
      studies, increase positive attitudes toward participating in trials and studies, and increase&#xD;
      their intent to enroll in trials and studies. Eligible attendees of the class will be&#xD;
      optionally invited to participate in the research evaluation of the class, using pre- and&#xD;
      post- surveys to assess achievement of the learning objectives. Study participants will also&#xD;
      be asked a series of questions to assess study participants' eligibility for existing&#xD;
      clinical trials and research studies and, as appropriate, referred to those&#xD;
      trial/study/clinical teams for follow-up.&#xD;
&#xD;
      Experimental Arm 2 (Aim 1b):&#xD;
&#xD;
      Implement online education regarding what clinical trials and cancer research are and&#xD;
      evaluate the effect on knowledge of, attitudes and behavioral intentions toward, and actual&#xD;
      enrollment into clinical trials and cancer research studies.&#xD;
&#xD;
      Participants will watch a video and view website materials ('online module') about clinical&#xD;
      trials and cancer research. The online module's learning objectives focus on improving&#xD;
      participants' knowledge about what clinical trials and cancer research studies are and how to&#xD;
      access trials and studies, increase positive attitudes toward participating in trials and&#xD;
      studies, and increase their intent to enroll in trials and studies. Eligible participants&#xD;
      will complete pre- and post- surveys to assess achievement of the learning objectives. Study&#xD;
      participants will also be asked a series of questions to assess study participants'&#xD;
      eligibility for existing clinical trials and research studies and, as appropriate, referred&#xD;
      to those trial/study/clinical teams for follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 31, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in participant knowledge related to what cancer research studies and clinical trials are as assessed before and after educational intervention</measure>
    <time_frame>Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention</time_frame>
    <description>A pre-test and post-test knowledge questionnaire conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via percent of correct and incorrect responses to 11 true/false questions)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change in behavioral intentions toward enrolling in clinical trials</measure>
    <time_frame>Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention</time_frame>
    <description>A pre-test and post-test questionnaire conducted with participants to assess any changes in behavioral intensions related to clinical trial enrollment (assessed via 4 Likert-scale questions)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change in enrollment status in cancer research studies and clinical trials as measured by tracking individual enrollment statuses at the time of intervention and after education</measure>
    <time_frame>Tracking from time of study participation in educational intervention and following study participants for six months monitoring change in enrollment status in cancer research and clinical trials</time_frame>
    <description>Change in enrollment status in cancer research or clinical trials as measured by participant's active status in cancer research or clinical trials project participation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Registered attendees of a group educational class events will have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via a geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group education</intervention_name>
    <description>Participants will receive education covering the key messages pertaining to cancer research studies and clinical trials, in a group class setting. Education will be facilitated with one or more of the following educational tools: PowerPoint presentation, written materials/handouts, and displays. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online educational video and website module</intervention_name>
    <description>Participants will receive online education via a video and written web content. Key messages will include information pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Experimental Arm 1 (group education):&#xD;
&#xD;
          -  Age 18 or older at the time of study enrollment&#xD;
&#xD;
        Inclusion Criteria for Experimental Arm 2 (online education):&#xD;
&#xD;
          -  Age 18 or older at the time of study enrollment&#xD;
&#xD;
          -  Resident of one of the RUCC 7-9 counties in NH or VT: Coos, Sullivan Counties in New&#xD;
             Hampshire or Caledonia, Windsor, Windham, Orange, Orleans, Lamoille or Essex Counties&#xD;
             in Vermont&#xD;
&#xD;
        Exclusion Criteria for both Experimental Arms:&#xD;
&#xD;
          -  Cognitive impairment preventing participation in informed consent process&#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>Judith R Rees, BM, BCh, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisel School of Medicine at Dartmouth College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Judith R. Rees</investigator_full_name>
    <investigator_title>Associate Professor of Epidemiology; Associate Professor of Community and Family Medicine; Associate Director for Community Outreach and Engagement</investigator_title>
  </responsible_party>
  <keyword>Education</keyword>
  <keyword>Clinical Trial</keyword>
  <keyword>Research</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT04409782/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04409782
org study id: D20039
secondary id: P30CA023108-40S4
nct id: NCT04409782
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates different ways to educate rural residents living in New Hampshire and
      Vermont about cancer research studies and clinical trials to increase knowledge of, increase
      positive attitudes toward, and encourage enrollment in cancer research studies and clinical
      trials. The information learned from this study will contribute to a nation-wide initiative
      to educate the public about clinical trials, including a nation-wide evaluation of that
      initiative. The results of this study may also help researchers understand how education
      about clinical trials/research affects knowledge of and attitudes toward cancer research and
      clinical trials, as well as behavioral intentions and actual behaviors related to enrolling
      in cancer research studies and clinical trials.
The study team will implement and evaluate the research study and clinical trials education
      in two experimental arms-

        1. group education (Aim 1a) and

        2. an online format (Aim 1b) The education in both formats will be based on a set of key
           messages that cover information about research studies and clinical trials, including
           what research studies are, the benefits, the risks, and connection to available research
           studies and clinical trials

      Experimental Arm 1 (Aim 1a) Implement group education regarding what clinical trials and
      cancer research are and evaluate the effect on knowledge of, attitudes and behavioral
      intentions toward, and actual enrollment into clinical trials and cancer research studies.

      Study team will evaluate group educational sessions regarding what clinical trials and cancer
      research studies are. The learning objectives focus on improving participants' knowledge
      about what clinical trials and cancer research studies are and how to access trials and
      studies, increase positive attitudes toward participating in trials and studies, and increase
      their intent to enroll in trials and studies. Eligible attendees of the class will be
      optionally invited to participate in the research evaluation of the class, using pre- and
      post- surveys to assess achievement of the learning objectives. Study participants will also
      be asked a series of questions to assess study participants' eligibility for existing
      clinical trials and research studies and, as appropriate, referred to those
      trial/study/clinical teams for follow-up.

      Experimental Arm 2 (Aim 1b):

      Implement online education regarding what clinical trials and cancer research are and
      evaluate the effect on knowledge of, attitudes and behavioral intentions toward, and actual
      enrollment into clinical trials and cancer research studies.

      Participants will watch a video and view website materials ('online module') about clinical
      trials and cancer research. The online module's learning objectives focus on improving
      participants' knowledge about what clinical trials and cancer research studies are and how to
      access trials and studies, increase positive attitudes toward participating in trials and
      studies, and increase their intent to enroll in trials and studies. Eligible participants
      will complete pre- and post- surveys to assess achievement of the learning objectives. Study
      participants will also be asked a series of questions to assess study participants'
      eligibility for existing clinical trials and research studies and, as appropriate, referred
      to those trial/study/clinical teams for follow-up.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percent change in participant knowledge related to what cancer research studies and clinical trials are as assessed before and after educational intervention
time frame: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
description: A pre-test and post-test knowledge questionnaire conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via percent of correct and incorrect responses to 11 true/false questions)
measure: Percent change in behavioral intentions toward enrolling in clinical trials
time frame: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
description: A pre-test and post-test questionnaire conducted with participants to assess any changes in behavioral intensions related to clinical trial enrollment (assessed via 4 Likert-scale questions)
measure: Percent change in enrollment status in cancer research studies and clinical trials as measured by tracking individual enrollment statuses at the time of intervention and after education
time frame: Tracking from time of study participation in educational intervention and following study participants for six months monitoring change in enrollment status in cancer research and clinical trials
description: Change in enrollment status in cancer research or clinical trials as measured by participant's active status in cancer research or clinical trials project participation
arm group label: Arm 1
arm group type: Experimental
description: Registered attendees of a group educational class events will have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.
arm group label: Arm 2
arm group type: Experimental
description: People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via a geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.
intervention type: Other
intervention name: Group education
description: Participants will receive education covering the key messages pertaining to cancer research studies and clinical trials, in a group class setting. Education will be facilitated with one or more of the following educational tools: PowerPoint presentation, written materials/handouts, and displays. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.
arm group label: Arm 1
intervention type: Other
intervention name: Online educational video and website module
description: Participants will receive online education via a video and written web content. Key messages will include information pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.
arm group label: Arm 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Judith R Rees, BM, BCh, MPH, PhD
role: Principal Investigator
affiliation: Geisel School of Medicine at Dartmouth College
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Judith R. Rees
investigator title: Associate Professor of Epidemiology; Associate Professor of Community and Family Medicine; Associate Director for Community Outreach and Engagement
sharing ipd: No
provided document: 