<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/NCT04471194</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00015480</org_study_id>
    <secondary_id>K22CA225705-01A1</secondary_id>
    <nct_id>NCT04471194</nct_id>
  </id_info>
  <brief_title>Multilevel Intervention Based on Colorectal Cancer (CRC) and Cervical Cancer Self-screening in Rural, Segregated Areas</brief_title>
  <official_title>Multilevel Intervention Based on CRC and Cervical Cancer Self-screening in Rural, Segregated Areas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests&#xD;
      and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational&#xD;
      materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer&#xD;
      screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated&#xD;
      counties of Pennsylvania.&#xD;
&#xD;
      The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted&#xD;
      educational materials, to women in rural, segregated areas could help increase cancer&#xD;
      screening, reduce geographic cancer disparities, and improve public health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests&#xD;
      and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational&#xD;
      materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer&#xD;
      screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated&#xD;
      counties of Pennsylvania. A control group of 110 women, also recruited through FQHCs in&#xD;
      rural, segregated counties of Pennsylvania, will be used for comparison; these women will&#xD;
      receive standard-of-care reminders for cancer screening and complete the baseline and&#xD;
      follow-up surveys.&#xD;
&#xD;
      The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted&#xD;
      educational materials, to women in rural, segregated areas could help increase cancer&#xD;
      screening, reduce geographic cancer disparities, and improve public health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2021</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests</measure>
    <time_frame>10 weeks</time_frame>
    <description>Difference in percentage of participants who self-report having had cervical cancer screening PLUS having had colorectal cancer screening (all modalities) by the end of the study period between the two arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests</measure>
    <time_frame>10 weeks</time_frame>
    <description>Difference in percentage of participants who completed at-home cervical cancer screening test PLUS completed at-home colorectal cancer screening test by the end of the study period between the two arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Colorectal Cancer Screening</condition>
  <condition>Cervical Cancer Screening</condition>
  <arm_group>
    <arm_group_label>Self-Sampling Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Self-sampling HPV test</intervention_name>
    <description>Tests for human papillomavirus from cervical cell sample</description>
    <arm_group_label>Self-Sampling Intervention</arm_group_label>
    <other_name>Evalyn® Brush</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fecal occult blood test</intervention_name>
    <description>Tests for human hemoglobin from blood in fecal samples</description>
    <arm_group_label>Self-Sampling Intervention</arm_group_label>
    <other_name>InSure® test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lives in rural, segregated county of Pennsylvania&#xD;
&#xD;
          -  able to speak, read, and communicate well in English&#xD;
&#xD;
          -  out of date for both cervical and colorectal cancer screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has had a partial or complete hysterectomy&#xD;
&#xD;
          -  has a family history of colorectal cancer&#xD;
&#xD;
          -  has a personal history of cervical or colorectal cancer&#xD;
&#xD;
          -  persons who are cognitively impaired&#xD;
&#xD;
          -  persons who are incarcerated&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Moss, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State College of Medicine</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <results_first_submitted>September 20, 2022</results_first_submitted>
  <results_first_submitted_qc>September 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2022</results_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Jennifer L. Moss, PhD</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Family and Community Medicine / Department of Public Health Sciences</investigator_title>
  </responsible_party>
  <keyword>Environmental barriers to cancer screening</keyword>
  <keyword>Person-level barriers to cancer screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <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>March 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04471194/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 13, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04471194/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The research team sent 3436 patients invitations to participate in the study. 200 patients responded. Of the 200 respondents that were contacted for follow-up: 62 were unreachable, 90 were ineligible to participate due to having a hysterectomy, and 48 were enrolled.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Self-Sampling Intervention</title>
          <description>Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.&#xD;
Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample&#xD;
Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Self-Sampling Intervention</title>
          <description>Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.&#xD;
Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample&#xD;
Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" spread="4.4"/>
                    <measurement group_id="B2" value="56" spread="4.3"/>
                    <measurement group_id="B3" value="56" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>household income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; $50,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$50,000+</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests</title>
        <description>Difference in percentage of participants who self-report having had cervical cancer screening PLUS having had colorectal cancer screening (all modalities) by the end of the study period between the two arms.</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Self-Sampling Intervention</title>
            <description>Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.&#xD;
Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample&#xD;
Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests</title>
          <description>Difference in percentage of participants who self-report having had cervical cancer screening PLUS having had colorectal cancer screening (all modalities) by the end of the study period between the two arms.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests</title>
        <description>Difference in percentage of participants who completed at-home cervical cancer screening test PLUS completed at-home colorectal cancer screening test by the end of the study period between the two arms.</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Self-Sampling Intervention</title>
            <description>Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.&#xD;
Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample&#xD;
Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests</title>
          <description>Difference in percentage of participants who completed at-home cervical cancer screening test PLUS completed at-home colorectal cancer screening test by the end of the study period between the two arms.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks (from the time of consent until the completion of the follow-up survey)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Self-Sampling Intervention</title>
          <description>Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.&#xD;
Self-sampling HPV test: Tests for human papillomavirus from cervical cell sample&#xD;
Fecal occult blood test: Tests for human hemoglobin from blood in fecal samples</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <limitations_and_caveats>Low recruitment of minorities; Lack of sufficient power in statistical analyses; Use of cervical cancer screening methods unapproved by the FDA, Use of self-report for primary outcome.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jennifer L. Moss, PhD</name_or_title>
      <organization>Pennsylvania State University College of Medicine</organization>
      <phone>717-531-0003 ext 323429</phone>
      <email>jmoss1@pennstatehealth.psu.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/NCT04471194
org study id: STUDY00015480
secondary id: K22CA225705-01A1
nct id: NCT04471194
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests
      and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational
      materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer
      screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated
      counties of Pennsylvania.

      The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted
      educational materials, to women in rural, segregated areas could help increase cancer
      screening, reduce geographic cancer disparities, and improve public health.
In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests
      and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational
      materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer
      screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated
      counties of Pennsylvania. A control group of 110 women, also recruited through FQHCs in
      rural, segregated counties of Pennsylvania, will be used for comparison; these women will
      receive standard-of-care reminders for cancer screening and complete the baseline and
      follow-up surveys.

      The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted
      educational materials, to women in rural, segregated areas could help increase cancer
      screening, reduce geographic cancer disparities, and improve public health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Investigator, Outcomes Assessor)
measure: Difference in Percentage of Participants Who Completed Any Cervical PLUS Colorectal Cancer Screening Tests
time frame: 10 weeks
description: Difference in percentage of participants who self-report having had cervical cancer screening PLUS having had colorectal cancer screening (all modalities) by the end of the study period between the two arms.
measure: Difference in Percentage of Participants Who Completed At-home Cervical PLUS Colorectal Cancer Screening Tests
time frame: 10 weeks
description: Difference in percentage of participants who completed at-home cervical cancer screening test PLUS completed at-home colorectal cancer screening test by the end of the study period between the two arms.
arm group label: Self-Sampling Intervention
arm group type: Experimental
description: Participants in this group will receive cervical and colorectal cancer self-sampling kits, instructions for completing the self-sampling kits, and educational materials about cervical and colorectal cancer.
arm group label: Control
arm group type: No Intervention
description: Participants in this group will receive a standardized letter informing them that they are out-of-date for both cervical and colorectal cancer screenings and should schedule an appointment with their provider to receive these screenings.
intervention type: Diagnostic Test
intervention name: Self-sampling HPV test
description: Tests for human papillomavirus from cervical cell sample
arm group label: Self-Sampling Intervention
other name: Evalyn® Brush
intervention type: Diagnostic Test
intervention name: Fecal occult blood test
description: Tests for human hemoglobin from blood in fecal samples
arm group label: Self-Sampling Intervention
other name: InSure® test
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Moss, PhD
role: Principal Investigator
affiliation: Penn State College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Jennifer L. Moss, PhD
investigator title: Assistant Professor, Department of Family and Community Medicine / Department of Public Health Sciences
mesh term: Colorectal Neoplasms
mesh term: Uterine Cervical Neoplasms
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Low recruitment of minorities; Lack of sufficient power in statistical analyses; Use of cervical cancer screening methods unapproved by the FDA, Use of self-report for primary outcome.
point of contact: 