<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/NCT04420273</url>
  </required_header>
  <id_info>
    <org_study_id>STU00212165</org_study_id>
    <nct_id>NCT04420273</nct_id>
  </id_info>
  <brief_title>Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access</brief_title>
  <acronym>TMD</acronym>
  <official_title>Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</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>
      The purpose of this study is to reduce melanoma mortality by improving early detection of&#xD;
      melanoma with skin self-examination (SSE) among people who self-identify as being at risk and&#xD;
      seek care for a concerning mole. Because women are more likely than men to perform SSE, women&#xD;
      who are engaged in health promotion by having a recent screening mammogram are the focus of&#xD;
      this research. Self-management of melanoma detection with SSE depends on ready access to&#xD;
      dermatologists when a concerning mole is detected. In March 2020, the Illinois stay at home&#xD;
      order (COVID-19) prohibited non-essential health care, including screening mammography and&#xD;
      dermatology office-based care, and both are expected to remain limited until fall 2020. This&#xD;
      submission explores a) the effectiveness of targeted melanoma detection (TMD) among women,&#xD;
      who identify their risk of having a melanoma, learn to perform SSE, and perform SSE, and b)&#xD;
      the effectiveness of adhesive patch-based home sample collection for genomic analysis to rule&#xD;
      out melanoma in moles identified by women (who received the intervention) as concerning will&#xD;
      be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed work will assess the effectiveness of targeted melanoma detection (TMD) with SSE&#xD;
      education delivered remotely to women who had a screening mammogram. The effect of TMD with&#xD;
      SSE education will be assessed with a randomized control trial among women served by&#xD;
      Northwestern Medicine in rural, suburban and metropolitan communities. Women who identify&#xD;
      concerning moles will choose among three options: a) watch the mole to see if the border,&#xD;
      color or diameter of the mole changes b) send a picture of the mole to the PI for&#xD;
      consideration of mole self-sampling, or c) make an appointment with my healthcare provider to&#xD;
      check the mole. As required a physician will supervise women, who will perform non-invasive&#xD;
      mole self-sampling with non-invasive adhesive patches for genomic analysis of the concerning&#xD;
      pigmented lesion (mole). If the genomic analysis suggests that the concerning mole may be a&#xD;
      melanoma, then the recommendation will be to have the mole biopsied.The effectiveness of&#xD;
      acquired samples suggestive of melanoma will be examined by the obtaining the pathology&#xD;
      reports of biopsied moles. Health care providers' (HCPs) clinical/pathologic assessment of&#xD;
      concerning moles will be identified in the Northwestern Medicine electronic health record&#xD;
      (EHR) system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</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>
    <intervention_model_description>Randomized Control Clinical Trial Arm 1: SSE educational intervention with optional physician supervised non-invasive adhesive patch-based home sample collection of a concerning mole for genomic analysis Arm 2: Active control</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Completed SSE at Specified Time Points</measure>
    <time_frame>90 days</time_frame>
    <description>Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Identified Concerning Moles at Specified Time Points</measure>
    <time_frame>90 days</time_frame>
    <description>Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants' Reported Skin Self-examination Anxiety</measure>
    <time_frame>90 days</time_frame>
    <description>Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' Confidence Performing Mole Checks</measure>
    <time_frame>90 days</time_frame>
    <description>Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles</measure>
    <time_frame>5 months</time_frame>
    <description>Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathologic Diagnosis of Concerning Moles</measure>
    <time_frame>5 months</time_frame>
    <description>Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biopsy Performed</measure>
    <time_frame>5 months</time_frame>
    <description>EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>SSE educational intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active control: Healthy Living</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SSE educational intervention</intervention_name>
    <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
    <arm_group_label>SSE educational intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active control:Healthy Living</intervention_name>
    <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
    <arm_group_label>Active control: Healthy Living</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult women (aged 18 and older) with no upper age limit, who had a screening mammogram&#xD;
             from January 1, 2019 to February 28, 2020.&#xD;
&#xD;
          -  Able to read English&#xD;
&#xD;
          -  Vision enough to read a newspaper&#xD;
&#xD;
          -  Self-perception of their potential melanoma risk&#xD;
&#xD;
          -  Willing to perform SSE either alone or with a skin check partner&#xD;
&#xD;
          -  Willing to complete monthly surveys for 3 months and receive monthly text messages to&#xD;
             personal mobile phone&#xD;
&#xD;
          -  Have home Internet access and phone with ability to take a picture of a mole&#xD;
&#xD;
          -  Have access to Federal Express or US Postal Service Express Mail to send mole&#xD;
             self-sampling kits&#xD;
&#xD;
          -  Willing to allow the research team access to their electronic health record to&#xD;
             abstract physician assessment of concerning moles, biopsy results and treatment&#xD;
&#xD;
          -  Willing to provide up-to-date email address, mailing address and telephone number&#xD;
&#xD;
        Inclusion criteria of skin check partner, who may be a man or a woman, to have mole&#xD;
        self-sampled&#xD;
&#xD;
          -  Male or female over the age of 18 years&#xD;
&#xD;
          -  Able to read English&#xD;
&#xD;
          -  Vision enough to read a newspaper&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Female under the age of 18&#xD;
&#xD;
          -  Unable to read English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-representation as a woman</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>June K Robinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University Feinberg School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Robinson JK, Reavy R, Mallett KA, Turrisi R. Remote partner assisted skin self-examination skills training of melanoma survivors and their partners. Australas J Dermatol. 2019 Feb;60(1):e80-e82. doi: 10.1111/ajd.12877. Epub 2018 Jul 10. No abstract available.</citation>
    <PMID>30773613</PMID>
  </reference>
  <reference>
    <citation>Robinson JK, Wayne JD, Martini MC, Hultgren BA, Mallett KA, Turrisi R. Early Detection of New Melanomas by Patients With Melanoma and Their Partners Using a Structured Skin Self-examination Skills Training Intervention: A Randomized Clinical Trial. JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985.</citation>
    <PMID>27367303</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <results_first_submitted>October 25, 2021</results_first_submitted>
  <results_first_submitted_qc>November 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 23, 2021</results_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>June Robinson</investigator_full_name>
    <investigator_title>Research Professor of Dermatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>April 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT04420273/Prot_SAP_000.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>May 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT04420273/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SSE Educational Intervention</title>
          <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
        </group>
        <group group_id="P2">
          <title>Active Control: Healthy Living</title>
          <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="501"/>
                <participants group_id="P2" count="499"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="390"/>
                <participants group_id="P2" count="414"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SSE Educational Intervention</title>
          <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
        </group>
        <group group_id="B2">
          <title>Active Control: Healthy Living</title>
          <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</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="494"/>
            <count group_id="B2" value="495"/>
            <count group_id="B3" value="989"/>
          </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="494"/>
                    <measurement group_id="B2" value="495"/>
                    <measurement group_id="B3" value="989"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.0" lower_limit="41.2" upper_limit="54.0"/>
                    <measurement group_id="B2" value="47.0" lower_limit="41.0" upper_limit="53.3"/>
                    <measurement group_id="B3" value="47.0" lower_limit="41.1" upper_limit="53.7"/>
                  </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="494"/>
                    <measurement group_id="B2" value="495"/>
                    <measurement group_id="B3" value="989"/>
                  </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="37"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="457"/>
                    <measurement group_id="B2" value="459"/>
                    <measurement group_id="B3" value="916"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="485"/>
                    <measurement group_id="B2" value="480"/>
                    <measurement group_id="B3" value="965"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>skin type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>I (always sunburn, never tan)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II (usually sunburn, tan minimally)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="230"/>
                    <measurement group_id="B3" value="443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III (sometimes sunburn, tan moderately)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV(rarely sunburn, tan deeply)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed SSE at Specified Time Points</title>
        <description>Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey</description>
        <time_frame>90 days</time_frame>
        <population>Home sample collection arm participants were randomized into arm 1 at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>SSE Educational Intervention</title>
            <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
          </group>
          <group group_id="O2">
            <title>Active Control: Healthy Living</title>
            <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed SSE at Specified Time Points</title>
          <description>Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey</description>
          <population>Home sample collection arm participants were randomized into arm 1 at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="494"/>
                <count group_id="O2" value="495"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline ever perform SSE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217"/>
                    <measurement group_id="O2" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-mo perform SSE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="475"/>
                    <measurement group_id="O2" value="238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-mo perform SSE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="355"/>
                    <measurement group_id="O2" value="228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-mo perform SSE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="348"/>
                    <measurement group_id="O2" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>1-month survey</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>McNemar</method>
            <method_desc>McNemar's chi-square with continuity correction</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>2- months</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>McNemar</method>
            <method_desc>McNemar's chi-square with continuity correction</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>3-months</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>McNemar</method>
            <method_desc>McNemar's chi-square with continuity correction</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Identified Concerning Moles at Specified Time Points</title>
        <description>Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.</description>
        <time_frame>90 days</time_frame>
        <population>While 494 participants were randomized to receive the intervention, only 278 participants found a concerning mole. Similarly 495 participants were randomized to the active control arm, but only 144 identified a concerning mole. Thus the number analyzed in each arm is limited to the number of participants identifying a concerning mole.</population>
        <group_list>
          <group group_id="O1">
            <title>SSE Educational Intervention</title>
            <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
          </group>
          <group group_id="O2">
            <title>Active Control: Healthy Living</title>
            <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Identified Concerning Moles at Specified Time Points</title>
          <description>Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.</description>
          <population>While 494 participants were randomized to receive the intervention, only 278 participants found a concerning mole. Similarly 495 participants were randomized to the active control arm, but only 144 identified a concerning mole. Thus the number analyzed in each arm is limited to the number of participants identifying a concerning mole.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Made physician appointment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Followed mole for change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>stopped SSE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants' Reported Skin Self-examination Anxiety</title>
        <description>Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SSE Educational Intervention</title>
            <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
          </group>
          <group group_id="O2">
            <title>Active Control: Healthy Living</title>
            <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Reported Skin Self-examination Anxiety</title>
          <description>Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="390"/>
                <count group_id="O2" value="414"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="0.05"/>
                    <measurement group_id="O2" value="6.4" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="0.05"/>
                    <measurement group_id="O2" value="6.6" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.1</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants' Confidence Performing Mole Checks</title>
        <description>Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SSE Educational Intervention</title>
            <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
          </group>
          <group group_id="O2">
            <title>Active Control: Healthy Living</title>
            <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Confidence Performing Mole Checks</title>
          <description>Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="390"/>
                <count group_id="O2" value="414"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="0.05"/>
                    <measurement group_id="O2" value="9.3" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up-3 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="0.05"/>
                    <measurement group_id="O2" value="10.0" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles</title>
        <description>Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months</description>
        <time_frame>5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SSE Educational Intervention</title>
            <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
          </group>
          <group group_id="O2">
            <title>Active Control: Healthy Living</title>
            <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles</title>
          <description>Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical diagnosis benign</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical diagnosis atypical nevus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical diagnosis melanoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pathologic Diagnosis of Concerning Moles</title>
        <description>Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning</description>
        <time_frame>5 months</time_frame>
        <population>all participants in arm 3 had benign moles on the home sample collected</population>
        <group_list>
          <group group_id="O1">
            <title>SSE Educational Intervention</title>
            <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
          </group>
          <group group_id="O2">
            <title>Active Control: Healthy Living</title>
            <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
          </group>
        </group_list>
        <measure>
          <title>Pathologic Diagnosis of Concerning Moles</title>
          <description>Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning</description>
          <population>all participants in arm 3 had benign moles on the home sample collected</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>benign nevus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>atypical nevus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>melanoma stage 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>melanoma stage 1A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>melanoma stage 1B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.459</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biopsy Performed</title>
        <description>EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed</description>
        <time_frame>5 months</time_frame>
        <population>percentage of participants having a biopsy of a concerning mole</population>
        <group_list>
          <group group_id="O1">
            <title>SSE Educational Intervention</title>
            <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
          </group>
          <group group_id="O2">
            <title>Active Control: Healthy Living</title>
            <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</description>
          </group>
        </group_list>
        <measure>
          <title>Biopsy Performed</title>
          <description>EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed</description>
          <population>percentage of participants having a biopsy of a concerning mole</population>
          <units>percentage of participants having a biop</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.4"/>
                    <measurement group_id="O2" value="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>two months after completing final 3-month survey of study</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SSE Educational Intervention</title>
          <description>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.&#xD;
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.</description>
        </group>
        <group group_id="E2">
          <title>Active Control: Healthy Living</title>
          <description>Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.&#xD;
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.</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="494"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="495"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="495"/>
              </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="494"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="495"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. June Robinson</name_or_title>
      <organization>Northwestern University Feinberg School of Medicine</organization>
      <phone>3129433703</phone>
      <email>june-robinson@northwestern.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/NCT04420273
org study id: STU00212165
nct id: NCT04420273
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to reduce melanoma mortality by improving early detection of
      melanoma with skin self-examination (SSE) among people who self-identify as being at risk and
      seek care for a concerning mole. Because women are more likely than men to perform SSE, women
      who are engaged in health promotion by having a recent screening mammogram are the focus of
      this research. Self-management of melanoma detection with SSE depends on ready access to
      dermatologists when a concerning mole is detected. In March 2020, the Illinois stay at home
      order (COVID-19) prohibited non-essential health care, including screening mammography and
      dermatology office-based care, and both are expected to remain limited until fall 2020. This
      submission explores a) the effectiveness of targeted melanoma detection (TMD) among women,
      who identify their risk of having a melanoma, learn to perform SSE, and perform SSE, and b)
      the effectiveness of adhesive patch-based home sample collection for genomic analysis to rule
      out melanoma in moles identified by women (who received the intervention) as concerning will
      be explored.
The proposed work will assess the effectiveness of targeted melanoma detection (TMD) with SSE
      education delivered remotely to women who had a screening mammogram. The effect of TMD with
      SSE education will be assessed with a randomized control trial among women served by
      Northwestern Medicine in rural, suburban and metropolitan communities. Women who identify
      concerning moles will choose among three options: a) watch the mole to see if the border,
      color or diameter of the mole changes b) send a picture of the mole to the PI for
      consideration of mole self-sampling, or c) make an appointment with my healthcare provider to
      check the mole. As required a physician will supervise women, who will perform non-invasive
      mole self-sampling with non-invasive adhesive patches for genomic analysis of the concerning
      pigmented lesion (mole). If the genomic analysis suggests that the concerning mole may be a
      melanoma, then the recommendation will be to have the mole biopsied.The effectiveness of
      acquired samples suggestive of melanoma will be examined by the obtaining the pathology
      reports of biopsied moles. Health care providers' (HCPs) clinical/pathologic assessment of
      concerning moles will be identified in the Northwestern Medicine electronic health record
      (EHR) system.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Control Clinical Trial Arm 1: SSE educational intervention with optional physician supervised non-invasive adhesive patch-based home sample collection of a concerning mole for genomic analysis Arm 2: Active control
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Who Completed SSE at Specified Time Points
time frame: 90 days
description: Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey
measure: Number of Participants Who Identified Concerning Moles at Specified Time Points
time frame: 90 days
description: Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.
measure: Participants' Reported Skin Self-examination Anxiety
time frame: 90 days
description: Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome
measure: Participants' Confidence Performing Mole Checks
time frame: 90 days
description: Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).
measure: Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles
time frame: 5 months
description: Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months
measure: Pathologic Diagnosis of Concerning Moles
time frame: 5 months
description: Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning
measure: Biopsy Performed
time frame: 5 months
description: EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed
arm group label: SSE educational intervention
arm group type: Experimental
description: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
arm group label: Active control: Healthy Living
arm group type: Active Comparator
description: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
intervention type: Behavioral
intervention name: SSE educational intervention
description: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
arm group label: SSE educational intervention
intervention type: Behavioral
intervention name: Active control:Healthy Living
description: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
arm group label: Active control: Healthy Living
criteria: 
gender: Female
gender based: Yes
gender description: Self-representation as a woman
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: June K Robinson, MD
role: Principal Investigator
affiliation: Northwestern University Feinberg School of Medicine
facility: 
country: United States
citation: Robinson JK, Reavy R, Mallett KA, Turrisi R. Remote partner assisted skin self-examination skills training of melanoma survivors and their partners. Australas J Dermatol. 2019 Feb;60(1):e80-e82. doi: 10.1111/ajd.12877. Epub 2018 Jul 10. No abstract available.
PMID: 30773613
citation: Robinson JK, Wayne JD, Martini MC, Hultgren BA, Mallett KA, Turrisi R. Early Detection of New Melanomas by Patients With Melanoma and Their Partners Using a Structured Skin Self-examination Skills Training Intervention: A Randomized Clinical Trial. JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985.
PMID: 27367303
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: June Robinson
investigator title: Research Professor of Dermatology
mesh term: Melanoma
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 