<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/NCT02973022</url>
  </required_header>
  <id_info>
    <org_study_id>UW16048</org_study_id>
    <secondary_id>2016-0941</secondary_id>
    <secondary_id>A534253</secondary_id>
    <secondary_id>SMPH\MEDICINE\GEN INT MD</secondary_id>
    <secondary_id>NCI-2019-06442</secondary_id>
    <nct_id>NCT02973022</nct_id>
    <nct_alias>NCT02886325</nct_alias>
  </id_info>
  <brief_title>A Community Based Approach to Reducing Rural Cancer Disparities, Aim 2</brief_title>
  <official_title>A Community Based Approach to Reducing Rural Cancer Disparities, Aim 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the impact of participation in Cancer Clear and Simple&#xD;
      (CC&amp;S) educational sessions on cancer prevention and screening. The researchers will recruit&#xD;
      60 community members: 30 will receive CC&amp;S training (intervention group) and 30 will not&#xD;
      (control group). All 60 will be surveyed about their intent to change their behavior at the&#xD;
      beginning of the study and their actual behavior changes and their screening behavior 6&#xD;
      months after enrollment in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2016</start_date>
  <completion_date type="Actual">September 17, 2018</completion_date>
  <primary_completion_date type="Actual">September 17, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in behavioral intent</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>All 60 participants (30 intervention, 30 control group) will be surveyed about their intent to change their behavior at the beginning of the study and their actual behavior changes and their cancer screening behavior 6 months after enrollment in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cancer knowledge</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Change in cancer knowledge measured before the educational session to after the session and duration of that knowledge as measured from right after the session to six months later.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Community CC&amp;S Group</arm_group_label>
    <description>Once participants are randomized, they will be given survey 1. The intervention group in the community will be exposed to the modified CC&amp;S educational sessions in a series of 2 one hour and 15 minute sessions on consecutive Monday nights. A free meal will be provided at both educational sessions. Childcare will be provided for community sessions. Once the final educational session is completed, all participants will be given survey 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Control Group</arm_group_label>
    <description>Once participants are randomized, they will be given survey 1. The control group in the community will be exposed to a nutrition education program in a series of 2 one hour and 15 minute sessions on consecutive Monday nights. A free meal will be provided at both educational session. Childcare will be provided for community sessions. Once the final educational session is completed, all participants will be given survey 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACEC CC&amp;S Group</arm_group_label>
    <description>Once participants are randomized, they will be given survey 1. The intervention group at ACEC (Adams-Columbia Electric Company) will be exposed to the modified CC&amp;S educational sessions in a series of 6 thirty minute sessions before the work day begins over the course of several weeks. The researchers anticipate that two sessions will occur per week and therefore the delivery of the whole intervention will take 3 weeks. A free meal will be provided at all 6 educational sessions. Once the final educational session is completed, all participants will be given survey 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACEC Control Group</arm_group_label>
    <description>Once participants are randomized, they will be given survey 1. The control group at ACEC will be exposed to a nutrition education program in a series of 6 thirty minute sessions before the work day begins over the course of several weeks. We anticipate that two sessions will occur per week and therefore the delivery of the whole intervention will take 3 weeks. A free meal will be provided at all 6 educational sessions. Once the final educational session is completed, all participants will be given survey 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CC&amp;S</intervention_name>
    <description>Three educational modules -- Cancer Basics, Cancer Prevention, and Cancer Screening -- intended to increase cancer awareness. The full CC&amp;S curriculum is currently available at http://chdi.wisc.edu/cancer-clear-simple-curriculum-rural-adaptation.</description>
    <arm_group_label>ACEC CC&amp;S Group</arm_group_label>
    <arm_group_label>Community CC&amp;S Group</arm_group_label>
    <other_name>Cancer Clear &amp; Simple</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Thirty ACEC employees and 30 residents of a rural Wisconsin county. The researchers will&#xD;
        work to make sure the sample is representative of the community in regards to age, gender,&#xD;
        and employments status.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Wisconsin resident&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Jacobs</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.uwhealth.org/uw-carbone-cancer-center/cancer/10252</url>
    <description>UW Carbone Cancer Center Home Page</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02973022
org study id: UW16048
secondary id: 2016-0941
secondary id: A534253
secondary id: SMPH\MEDICINE\GEN INT MD
secondary id: NCI-2019-06442
nct id: NCT02973022
nct alias: NCT02886325
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The aim of this study is to evaluate the impact of participation in Cancer Clear and Simple
      (CC&S) educational sessions on cancer prevention and screening. The researchers will recruit
      60 community members: 30 will receive CC&S training (intervention group) and 30 will not
      (control group). All 60 will be surveyed about their intent to change their behavior at the
      beginning of the study and their actual behavior changes and their screening behavior 6
      months after enrollment in the study.
observational model: Case-Control
time perspective: Prospective
measure: Change in behavioral intent
time frame: Up to 3 weeks
description: All 60 participants (30 intervention, 30 control group) will be surveyed about their intent to change their behavior at the beginning of the study and their actual behavior changes and their cancer screening behavior 6 months after enrollment in the study.
measure: Change in cancer knowledge
time frame: Up to 6 months
description: Change in cancer knowledge measured before the educational session to after the session and duration of that knowledge as measured from right after the session to six months later.
arm group label: Community CC&S Group
description: Once participants are randomized, they will be given survey 1. The intervention group in the community will be exposed to the modified CC&S educational sessions in a series of 2 one hour and 15 minute sessions on consecutive Monday nights. A free meal will be provided at both educational sessions. Childcare will be provided for community sessions. Once the final educational session is completed, all participants will be given survey 2.
arm group label: Community Control Group
description: Once participants are randomized, they will be given survey 1. The control group in the community will be exposed to a nutrition education program in a series of 2 one hour and 15 minute sessions on consecutive Monday nights. A free meal will be provided at both educational session. Childcare will be provided for community sessions. Once the final educational session is completed, all participants will be given survey 2.
arm group label: ACEC CC&S Group
description: Once participants are randomized, they will be given survey 1. The intervention group at ACEC (Adams-Columbia Electric Company) will be exposed to the modified CC&S educational sessions in a series of 6 thirty minute sessions before the work day begins over the course of several weeks. The researchers anticipate that two sessions will occur per week and therefore the delivery of the whole intervention will take 3 weeks. A free meal will be provided at all 6 educational sessions. Once the final educational session is completed, all participants will be given survey 2.
arm group label: ACEC Control Group
description: Once participants are randomized, they will be given survey 1. The control group at ACEC will be exposed to a nutrition education program in a series of 6 thirty minute sessions before the work day begins over the course of several weeks. We anticipate that two sessions will occur per week and therefore the delivery of the whole intervention will take 3 weeks. A free meal will be provided at all 6 educational sessions. Once the final educational session is completed, all participants will be given survey 2.
intervention type: Other
intervention name: CC&S
description: Three educational modules -- Cancer Basics, Cancer Prevention, and Cancer Screening -- intended to increase cancer awareness. The full CC&S curriculum is currently available at http://chdi.wisc.edu/cancer-clear-simple-curriculum-rural-adaptation.
arm group label: ACEC CC&S Group
arm group label: Community CC&S Group
other name: Cancer Clear & Simple
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth Jacobs
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: http://www.uwhealth.org/uw-carbone-cancer-center/cancer/10252
description: UW Carbone Cancer Center Home Page
responsible party type: Sponsor