<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/NCT03287453</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-17069</org_study_id>
    <secondary_id>NCI-2017-01357</secondary_id>
    <secondary_id>OSU-17069</secondary_id>
    <secondary_id>P30CA016058</secondary_id>
    <nct_id>NCT03287453</nct_id>
  </id_info>
  <brief_title>Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer</brief_title>
  <official_title>Screen to Save Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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 clinical trial studies how well educational intervention works in improving knowledge&#xD;
      and screening rates of colorectal cancer. An educational intervention, such as viewing an&#xD;
      inflatable colon, PowerPoint presentation, or flip books/flipcharts, may help improve&#xD;
      knowledge about colorectal cancer and how often people get checked for colorectal cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To increase colorectal cancer (CRC) knowledge, attitudes, positive behavior change, intent&#xD;
      for screening, and screening among at-risk groups.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants attend educational sessions comprising of an inflatable colon interactive&#xD;
      exhibit that allows visitors to walk through a colon while seeing images, or a PowerPoint&#xD;
      presentation that contains messages that are tailored to meet the cultural and linguistic&#xD;
      needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and flip books/flip&#xD;
      charts. Participants also receive a copy of the study information sheet which contains the&#xD;
      basic elements of informed consent and a pre-education session knowledge survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 8, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge and degree to which reported intentions regarding colorectal cancer screening are related to the educational session</measure>
    <time_frame>Up to two years</time_frame>
    <description>Change in knowledge will be examined as a function of the important covariates: race/ethnicity, sex, age, education and primary language. A paired t-test or Wilcoxon signed-rank test will be used to determine whether there is a statistically significant difference in pre and post session scores. The paired t-test provides a hypothesis test to determine whether pre and post session assessment mean scores differ from each other in a significant way under the assumptions that the paired differences are independent and identically normally distributed. The test statistic is t with n-1 degrees of f</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knowledge and strength of intention to be screened</measure>
    <time_frame>Up to two years</time_frame>
    <description>Will be correlated with key outcomes, specifically actual screening and actions promoting colorectal cancer screening (e.g., encouraging colorectal screening with family/friends). Multivariable logistic regression analyses will be conducted to examine the impact of knowledge change and strength of intentions on these binary outcomes (screened/not screened and encouraged/did not encourage colorectal screening) controlling for important covariates such as sex, race/ethnicity, age, education and primary language. A paired t-test or Wilcoxon signed-rank test will be used to determine whether there</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of reported family history of colorectal cancer</measure>
    <time_frame>Up to two years</time_frame>
    <description>Will be described in total and as a function of specific racial/ethnic groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants' plans for future screening</measure>
    <time_frame>Up to two years</time_frame>
    <description>Will examine relationships between stated plans and key covariates.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons reported for not obtaining colorectal screening</measure>
    <time_frame>Up to two years</time_frame>
    <description>Response categories will be examined by key covariates.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported intentions to engage in behavior change to reduce risk of colorectal cancer</measure>
    <time_frame>Up to two years</time_frame>
    <description>Will be examined by race/ethnicity, sex, education, and health insurance/healthcare coverage.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Screening (educational intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants attend educational sessions comprising of an inflatable colon interactive exhibit that allows visitors to walk through a colon while seeing images, a PowerPoint presentation that contains messages that are tailored to meet the cultural and linguistic needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and or flip books/flip charts. Participants also receive a copy of the study information sheet which contains the basic elements of informed consent and a pre-education session knowledge survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>View an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts</description>
    <arm_group_label>Screening (educational intervention)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Screening (educational intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants from Franklin County or from Appalachia Ohio (depending on program&#xD;
             location)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Electra Paskett, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Electra Paskett</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03287453
org study id: OSU-17069
secondary id: NCI-2017-01357
secondary id: OSU-17069
secondary id: P30CA016058
nct id: NCT03287453
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical trial studies how well educational intervention works in improving knowledge
      and screening rates of colorectal cancer. An educational intervention, such as viewing an
      inflatable colon, PowerPoint presentation, or flip books/flipcharts, may help improve
      knowledge about colorectal cancer and how often people get checked for colorectal cancers.
PRIMARY OBJECTIVES:

      I. To increase colorectal cancer (CRC) knowledge, attitudes, positive behavior change, intent
      for screening, and screening among at-risk groups.

      OUTLINE:

      Participants attend educational sessions comprising of an inflatable colon interactive
      exhibit that allows visitors to walk through a colon while seeing images, or a PowerPoint
      presentation that contains messages that are tailored to meet the cultural and linguistic
      needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and flip books/flip
      charts. Participants also receive a copy of the study information sheet which contains the
      basic elements of informed consent and a pre-education session knowledge survey.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Change in knowledge and degree to which reported intentions regarding colorectal cancer screening are related to the educational session
time frame: Up to two years
description: Change in knowledge will be examined as a function of the important covariates: race/ethnicity, sex, age, education and primary language. A paired t-test or Wilcoxon signed-rank test will be used to determine whether there is a statistically significant difference in pre and post session scores. The paired t-test provides a hypothesis test to determine whether pre and post session assessment mean scores differ from each other in a significant way under the assumptions that the paired differences are independent and identically normally distributed. The test statistic is t with n-1 degrees of f
measure: Change in knowledge and strength of intention to be screened
time frame: Up to two years
description: Will be correlated with key outcomes, specifically actual screening and actions promoting colorectal cancer screening (e.g., encouraging colorectal screening with family/friends). Multivariable logistic regression analyses will be conducted to examine the impact of knowledge change and strength of intentions on these binary outcomes (screened/not screened and encouraged/did not encourage colorectal screening) controlling for important covariates such as sex, race/ethnicity, age, education and primary language. A paired t-test or Wilcoxon signed-rank test will be used to determine whether there
measure: Frequency of reported family history of colorectal cancer
time frame: Up to two years
description: Will be described in total and as a function of specific racial/ethnic groups.
measure: Participants' plans for future screening
time frame: Up to two years
description: Will examine relationships between stated plans and key covariates.
measure: Reasons reported for not obtaining colorectal screening
time frame: Up to two years
description: Response categories will be examined by key covariates.
measure: Self-reported intentions to engage in behavior change to reduce risk of colorectal cancer
time frame: Up to two years
description: Will be examined by race/ethnicity, sex, education, and health insurance/healthcare coverage.
arm group label: Screening (educational intervention)
arm group type: Experimental
description: Participants attend educational sessions comprising of an inflatable colon interactive exhibit that allows visitors to walk through a colon while seeing images, a PowerPoint presentation that contains messages that are tailored to meet the cultural and linguistic needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and or flip books/flip charts. Participants also receive a copy of the study information sheet which contains the basic elements of informed consent and a pre-education session knowledge survey.
intervention type: Other
intervention name: Educational Intervention
description: View an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts
arm group label: Screening (educational intervention)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Screening (educational intervention)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Electra Paskett, PhD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Electra Paskett
investigator title: Principal Investigator
mesh term: Colorectal Neoplasms