<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/NCT03028948</url>
  </required_header>
  <id_info>
    <org_study_id>131403</org_study_id>
    <secondary_id>NCI-2017-00084</secondary_id>
    <secondary_id>Pro2014000095</secondary_id>
    <secondary_id>Pro2014000095</secondary_id>
    <secondary_id>R01CA171666</secondary_id>
    <nct_id>NCT03028948</nct_id>
  </id_info>
  <brief_title>Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma</brief_title>
  <official_title>Internet Intervention for Sun Protection and Skin Self-check Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies how well an interactive tailored website works in promoting sun&#xD;
      protection and skin self-check behaviors in patients with stage 0-III melanoma. An&#xD;
      internet-based program may help individuals to perform skin self-checks and engage in sun&#xD;
      protection behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the impact of the interactive tailored website (ITW) versus usual care on skin&#xD;
      self-examination (SSE) and sun protection behaviors among individuals diagnosed with&#xD;
      melanoma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To examine mediators of the impact of the intervention. The effects of the intervention on&#xD;
      SSE and sun protection behaviors will be mediated by melanoma knowledge, self-efficacy for&#xD;
      SSE and sun protection behaviors, perceived benefits of SSE and sun protection behaviors,&#xD;
      perceived barriers to SSE and sun protection behaviors, and perceived controllability of&#xD;
      melanoma.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To examine moderators of the impact of the intervention. To evaluate whether ITW effects&#xD;
      are moderated by the following factors: time since diagnosis, disease stage, age, sex,&#xD;
      income, education, Internet experience, distress about melanoma, worry about recurrence, and&#xD;
      evaluation and usage of the ITW.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Phase I: Patients review draft website content materials in a semi-structured format and&#xD;
      provide feedback via open- and closed-ended questions for the development, testing, and&#xD;
      finalization of ITW.&#xD;
&#xD;
      Phase II: Patients are randomized into 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients access ITW and complete each module over 30-40 minutes.&#xD;
&#xD;
      ARM II: Patients receive usual care and are then offered ITW.&#xD;
&#xD;
      All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Actual">July 12, 2019</completion_date>
  <primary_completion_date type="Actual">July 12, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sun Protection Behavior Index</measure>
    <time_frame>At 24 weeks</time_frame>
    <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months</measure>
    <time_frame>8 weeks</time_frame>
    <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months</measure>
    <time_frame>At 24 weeks</time_frame>
    <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months</measure>
    <time_frame>48 weeks</time_frame>
    <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of SSEs Performed</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Total number of SSEs performed (regardless of their thoroughness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Body Areas Examined</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Total number of body areas examined during the most recent SSE in the last 2 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Tools to Facilitate SSE</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Use of a mirror, having someone else help, or using a body mole map during the most recent SSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Frequency (from 1 = never to 5 = always) of wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sunburns</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Total number of sunburns received</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wearing Long Pants</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Frequency (from 1 = never to 5 = always) of wearing long pants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wearing Sunglasses</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Frequency (from 1 = never to 5 = always) of wearing sunglasses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sunbathing</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sun Protection Behavior Index</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sun Protection Behavior Index</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sun Protection Behavior Index</measure>
    <time_frame>At 48 weeks</time_frame>
    <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Distress About Melanoma</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Level of distress (from 1 = not at all distressed to 10 = extremely distressed)</description>
  </other_outcome>
  <other_outcome>
    <measure>Worry About Melanoma Recurrence</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Mean rating of four questions regarding worry about melanoma recurrence</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Risk of Melanoma Recurrence</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Mean rating of four questions regarding perceived risk of melanoma recurrence</description>
  </other_outcome>
  <other_outcome>
    <measure>Biopsies Conducted</measure>
    <time_frame>At 48 weeks</time_frame>
    <description>Number of biopsies conducted</description>
  </other_outcome>
  <other_outcome>
    <measure>Indoor Tanning</measure>
    <time_frame>At 48 weeks</time_frame>
    <description>Number of times indoor tanned in the past year</description>
  </other_outcome>
  <other_outcome>
    <measure>Diagnosis of New or Recurrent Skin Cancers</measure>
    <time_frame>At 48 weeks</time_frame>
    <description>Whether a new or recurrent skin cancer was diagnosed</description>
  </other_outcome>
  <other_outcome>
    <measure>Indicators of Study Feasibility</measure>
    <time_frame>At 48 weeks</time_frame>
    <description>Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.</description>
  </other_outcome>
  <other_outcome>
    <measure>Visits to Healthcare Provider Related to Skin Surveillance</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Receipt of a physician skin examination and the reason for the visit</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact and Effectiveness of the Interactive Tailored Website</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.</description>
  </other_outcome>
  <other_outcome>
    <measure>Usage of the Interactive Tailored Website</measure>
    <time_frame>At 8, 24 and 48 weeks</time_frame>
    <description>Number of visits to the website, the number of monthly skin self-checks completed, the number of updates to the sun-safe action plan, and starting/completing the remaining sections of the website (Introduction; Getting Ready to Do a Skin Self-Check; Practice Sun-Safe Behaviors).</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation and Utility of the Interactive Tailored Website</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">485</enrollment>
  <condition>Stage 0 Skin Melanoma</condition>
  <condition>Stage I Skin Melanoma</condition>
  <condition>Stage IA Skin Melanoma</condition>
  <condition>Stage IB Skin Melanoma</condition>
  <condition>Stage II Skin Melanoma</condition>
  <condition>Stage IIA Skin Melanoma</condition>
  <condition>Stage IIB Skin Melanoma</condition>
  <condition>Stage IIC Skin Melanoma</condition>
  <condition>Stage III Skin Melanoma</condition>
  <condition>Stage IIIA Skin Melanoma</condition>
  <condition>Stage IIIB Skin Melanoma</condition>
  <condition>Stage IIIC Skin Melanoma</condition>
  <arm_group>
    <arm_group_label>Arm I (ITW)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients access ITW and complete each module over 30-40 minutes. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (usual care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive usual care and are then offered ITW. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Access ITW</description>
    <arm_group_label>Arm I (ITW)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (ITW)</arm_group_label>
    <arm_group_label>Arm II (usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (ITW)</arm_group_label>
    <arm_group_label>Arm II (usual care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase I: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma&#xD;
&#xD;
          -  Phase I: From 3-36 months post-surgical treatment&#xD;
&#xD;
          -  Phase I: Access to the internet&#xD;
&#xD;
          -  Phase I: Able to speak and read English&#xD;
&#xD;
          -  Phase I: Able to provide informed consent&#xD;
&#xD;
          -  Phase II: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma&#xD;
&#xD;
          -  Phase II: From 3-24 months post-surgical treatment&#xD;
&#xD;
          -  Phase II: Not adherent to thorough SSE (i.e., did not check every area of the body at&#xD;
             least once during the past 2 months)&#xD;
&#xD;
          -  Phase II: Not adherent to sun protection recommendations (i.e., mean score &lt; 4 [which&#xD;
             corresponds to &quot;often&quot;] on a 5-point scale [from 1 = &quot;never&quot; to 5 = &quot;always&quot;] that&#xD;
             assesses the frequency of engaging in four sun protection behaviors)&#xD;
&#xD;
          -  Phase II: Access to a computer connected to the internet&#xD;
&#xD;
          -  Phase II: Able to speak and read English&#xD;
&#xD;
          -  Phase II: Able to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elliot Coups</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>July 27, 2022</results_first_submitted>
  <results_first_submitted_qc>February 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2023</results_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Sharon Manne, PhD</investigator_full_name>
    <investigator_title>Professor and Associate Director of Population Science</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Skin 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>April 5, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03028948/Prot_SAP_001.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>April 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03028948/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 485 consented participants, 441 completed baseline survey and were randomized to treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>mySmartSkin</title>
          <description>Of 485 enrolled individuals, 224 were randomized to MSS.&#xD;
These individuals access MSS content and complete the three educational Cores. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Of the 485 enrolled individuals, 217 were randomized to the UC condition.&#xD;
These participants received the usual clinical follow-up care. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>8 Week Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="224"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="215"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>24 Week Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="224"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="189"/>
                <participants group_id="P2" count="207"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>48 Week Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="224"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="202"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>mySmartSkin</title>
          <description>Of 485 enrolled individuals, 224 were randomized to MSS.&#xD;
These individuals access MSS content and complete the three educational Cores. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Of the 485 enrolled individuals, 217 were randomized to the UC condition.&#xD;
These participants received the usual clinical follow-up care. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.</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="224"/>
            <count group_id="B2" value="217"/>
            <count group_id="B3" value="441"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="62.0" spread="12.9"/>
                    <measurement group_id="B2" value="60.8" spread="13.7"/>
                    <measurement group_id="B3" value="61.4" spread="13.3"/>
                  </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="103"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Non-Hispanic White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="218"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hispanic Black</title>
              <category_list>
                <category>
                  <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>
              <title>Non-Hispanic Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>≤ High school graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Annual Household Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>≤ $59,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$60,000 to $99,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$100,000 to $149,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ $150,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Married/partnered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                    <measurement group_id="B2" value="172"/>
                    <measurement group_id="B3" value="351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not married/partnered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Frequency of using the Internet</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>2 or fewer days/week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 to 5 days/week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once a day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 to 3 times/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 or more times/day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of comfort using the Internet</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Very uncomfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat uncomfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither comfortable nor uncomfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat comfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very comfortable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of melanoma risk factors (range 0-8)</title>
          <units>risk factors</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.3" spread="1.7"/>
                    <measurement group_id="B2" value="4.4" spread="1.6"/>
                    <measurement group_id="B3" value="4.4" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since melanoma surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>3 to &lt; 14 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14 to 24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease stage</title>
          <description>Disease stage refers to primary pathologic stage of cutaneous malignant melanoma that the participant was diagnosed with. In this study, stage 0 and I are considered early stage melanoma. Earlier stages are associated with better outcomes and less serious disease.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sun Protection Behavior Index</title>
        <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
        <time_frame>At 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
        </group_list>
        <measure>
          <title>Sun Protection Behavior Index</title>
          <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
          <units>scores 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="189"/>
                <count group_id="O2" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.54" spread="0.74"/>
                    <measurement group_id="O2" value="3.37" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months</title>
        <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 2 months and 6 months.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 2 months and 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months</title>
          <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.</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="198"/>
                <count group_id="O2" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                    <measurement group_id="O2" value="199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months</title>
        <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months</description>
        <time_frame>At 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 4 months.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 4 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months</title>
          <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months</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="189"/>
                <count group_id="O2" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="182"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months</title>
        <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months</description>
        <time_frame>48 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 6 months.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months</title>
          <description>Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months</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="180"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="169"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of SSEs Performed</title>
        <description>Total number of SSEs performed (regardless of their thoroughness)</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Body Areas Examined</title>
        <description>Total number of body areas examined during the most recent SSE in the last 2 months</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Tools to Facilitate SSE</title>
        <description>Use of a mirror, having someone else help, or using a body mole map during the most recent SSE</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index</title>
        <description>Frequency (from 1 = never to 5 = always) of wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Sunburns</title>
        <description>Total number of sunburns received</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wearing Long Pants</title>
        <description>Frequency (from 1 = never to 5 = always) of wearing long pants</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wearing Sunglasses</title>
        <description>Frequency (from 1 = never to 5 = always) of wearing sunglasses</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sunbathing</title>
        <description>Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Distress About Melanoma</title>
        <description>Level of distress (from 1 = not at all distressed to 10 = extremely distressed)</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Worry About Melanoma Recurrence</title>
        <description>Mean rating of four questions regarding worry about melanoma recurrence</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Perceived Risk of Melanoma Recurrence</title>
        <description>Mean rating of four questions regarding perceived risk of melanoma recurrence</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Biopsies Conducted</title>
        <description>Number of biopsies conducted</description>
        <time_frame>At 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Indoor Tanning</title>
        <description>Number of times indoor tanned in the past year</description>
        <time_frame>At 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Diagnosis of New or Recurrent Skin Cancers</title>
        <description>Whether a new or recurrent skin cancer was diagnosed</description>
        <time_frame>At 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Indicators of Study Feasibility</title>
        <description>Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.</description>
        <time_frame>At 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Visits to Healthcare Provider Related to Skin Surveillance</title>
        <description>Receipt of a physician skin examination and the reason for the visit</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Impact and Effectiveness of the Interactive Tailored Website</title>
        <description>Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.</description>
        <time_frame>At 8 weeks</time_frame>
        <population>This survey was only conducted among those who were randomized to MSS</population>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Did not complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Impact and Effectiveness of the Interactive Tailored Website</title>
          <description>Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.</description>
          <population>This survey was only conducted among those who were randomized to MSS</population>
          <units>scores on 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="198"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Usage of the Interactive Tailored Website</title>
        <description>Number of visits to the website, the number of monthly skin self-checks completed, the number of updates to the sun-safe action plan, and starting/completing the remaining sections of the website (Introduction; Getting Ready to Do a Skin Self-Check; Practice Sun-Safe Behaviors).</description>
        <time_frame>At 8, 24 and 48 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation and Utility of the Interactive Tailored Website</title>
        <description>Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.</description>
        <time_frame>At 8 weeks</time_frame>
        <population>Only the participants randomized to the intervention arm completed this survey</population>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>At the 8 week follow-up, participants enrolled in the MSS intervention completed a 15-item Evaluation and Utility survey, which assessed program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program (1=not at all, 5=very).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Did not complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation and Utility of the Interactive Tailored Website</title>
          <description>Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.</description>
          <population>Only the participants randomized to the intervention arm completed this survey</population>
          <units>scores 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="198"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sun Protection Behavior Index</title>
        <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
        </group_list>
        <measure>
          <title>Sun Protection Behavior Index</title>
          <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
          <units>scores 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="224"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" spread=".75"/>
                    <measurement group_id="O2" value="3.29" spread=".76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sun Protection Behavior Index</title>
        <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
        <time_frame>At 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
        </group_list>
        <measure>
          <title>Sun Protection Behavior Index</title>
          <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
          <units>scores 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="198"/>
                <count group_id="O2" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread=".78"/>
                    <measurement group_id="O2" value="3.31" spread=".81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sun Protection Behavior Index</title>
        <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
        <time_frame>At 48 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mySmartSkin</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 5=always).</description>
          </group>
        </group_list>
        <measure>
          <title>Sun Protection Behavior Index</title>
          <description>Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.</description>
          <units>scores 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="179"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.65" spread=".72"/>
                    <measurement group_id="O2" value="3.52" spread=".79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were not monitored/assessed</time_frame>
      <desc>Adverse events were not monitored/assessed. There is no risk for participating in this study and, therefore, zero participants are at risk of facing an adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>mySmartSkin</title>
          <description>Of 485 enrolled individuals, 224 were randomized to MSS.&#xD;
These individuals access MSS content and complete the three educational Cores. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Of the 485 enrolled individuals, 217 were randomized to the UC condition.&#xD;
These participants received the usual clinical follow-up care. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Findings may be less generalizable to those with low sun protection behavior. We recruited from one state so participant pool may not represent the US population. SSE and sun protection were assessed using self-report. Sun content was in the last core and reviewed by fewer participants. Sample was primarily non-Hispanic white.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sharon Manne</name_or_title>
      <organization>Rutgers Cancer Institute of New Jersey</organization>
      <phone>7322356759</phone>
      <email>mannesl@cinj.rutgers.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/NCT03028948
org study id: 131403
secondary id: NCI-2017-00084
secondary id: Pro2014000095
secondary id: Pro2014000095
secondary id: R01CA171666
nct id: NCT03028948
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial studies how well an interactive tailored website works in promoting sun
      protection and skin self-check behaviors in patients with stage 0-III melanoma. An
      internet-based program may help individuals to perform skin self-checks and engage in sun
      protection behaviors.
PRIMARY OBJECTIVES:

      I. To evaluate the impact of the interactive tailored website (ITW) versus usual care on skin
      self-examination (SSE) and sun protection behaviors among individuals diagnosed with
      melanoma.

      SECONDARY OBJECTIVES:

      I. To examine mediators of the impact of the intervention. The effects of the intervention on
      SSE and sun protection behaviors will be mediated by melanoma knowledge, self-efficacy for
      SSE and sun protection behaviors, perceived benefits of SSE and sun protection behaviors,
      perceived barriers to SSE and sun protection behaviors, and perceived controllability of
      melanoma.

      TERTIARY OBJECTIVES:

      I. To examine moderators of the impact of the intervention. To evaluate whether ITW effects
      are moderated by the following factors: time since diagnosis, disease stage, age, sex,
      income, education, Internet experience, distress about melanoma, worry about recurrence, and
      evaluation and usage of the ITW.

      OUTLINE:

      Phase I: Patients review draft website content materials in a semi-structured format and
      provide feedback via open- and closed-ended questions for the development, testing, and
      finalization of ITW.

      Phase II: Patients are randomized into 1 of 2 arms.

      ARM I: Patients access ITW and complete each module over 30-40 minutes.

      ARM II: Patients receive usual care and are then offered ITW.

      All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Sun Protection Behavior Index
time frame: At 24 weeks
description: Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
measure: Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months
time frame: 8 weeks
description: Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.
measure: Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
time frame: At 24 weeks
description: Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months
measure: Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
time frame: 48 weeks
description: Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
measure: Number of SSEs Performed
time frame: At 8, 24 and 48 weeks
description: Total number of SSEs performed (regardless of their thoroughness)
measure: Number of Body Areas Examined
time frame: At 8, 24 and 48 weeks
description: Total number of body areas examined during the most recent SSE in the last 2 months
measure: Use of Tools to Facilitate SSE
time frame: At 8, 24 and 48 weeks
description: Use of a mirror, having someone else help, or using a body mole map during the most recent SSE
measure: Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index
time frame: At 8, 24 and 48 weeks
description: Frequency (from 1 = never to 5 = always) of wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade
measure: Number of Sunburns
time frame: At 8, 24 and 48 weeks
description: Total number of sunburns received
measure: Wearing Long Pants
time frame: At 8, 24 and 48 weeks
description: Frequency (from 1 = never to 5 = always) of wearing long pants
measure: Wearing Sunglasses
time frame: At 8, 24 and 48 weeks
description: Frequency (from 1 = never to 5 = always) of wearing sunglasses
measure: Sunbathing
time frame: At 8, 24 and 48 weeks
description: Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
measure: Sun Protection Behavior Index
time frame: Baseline
description: Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
measure: Sun Protection Behavior Index
time frame: At 8 weeks
description: Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
measure: Sun Protection Behavior Index
time frame: At 48 weeks
description: Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
measure: Distress About Melanoma
time frame: At 8, 24 and 48 weeks
description: Level of distress (from 1 = not at all distressed to 10 = extremely distressed)
measure: Worry About Melanoma Recurrence
time frame: At 8, 24 and 48 weeks
description: Mean rating of four questions regarding worry about melanoma recurrence
measure: Perceived Risk of Melanoma Recurrence
time frame: At 8, 24 and 48 weeks
description: Mean rating of four questions regarding perceived risk of melanoma recurrence
measure: Biopsies Conducted
time frame: At 48 weeks
description: Number of biopsies conducted
measure: Indoor Tanning
time frame: At 48 weeks
description: Number of times indoor tanned in the past year
measure: Diagnosis of New or Recurrent Skin Cancers
time frame: At 48 weeks
description: Whether a new or recurrent skin cancer was diagnosed
measure: Indicators of Study Feasibility
time frame: At 48 weeks
description: Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.
measure: Visits to Healthcare Provider Related to Skin Surveillance
time frame: At 8, 24 and 48 weeks
description: Receipt of a physician skin examination and the reason for the visit
measure: Impact and Effectiveness of the Interactive Tailored Website
time frame: At 8 weeks
description: Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.
measure: Usage of the Interactive Tailored Website
time frame: At 8, 24 and 48 weeks
description: Number of visits to the website, the number of monthly skin self-checks completed, the number of updates to the sun-safe action plan, and starting/completing the remaining sections of the website (Introduction; Getting Ready to Do a Skin Self-Check; Practice Sun-Safe Behaviors).
measure: Evaluation and Utility of the Interactive Tailored Website
time frame: At 8 weeks
description: Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.
arm group label: Arm I (ITW)
arm group type: Experimental
description: Patients access ITW and complete each module over 30-40 minutes. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
arm group label: Arm II (usual care)
arm group type: Active Comparator
description: Patients receive usual care and are then offered ITW. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
intervention type: Other
intervention name: Internet-Based Intervention
description: Access ITW
arm group label: Arm I (ITW)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (ITW)
arm group label: Arm II (usual care)
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Arm I (ITW)
arm group label: Arm II (usual care)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elliot Coups
role: Principal Investigator
affiliation: Rutgers Cancer Institute of New Jersey
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Sharon Manne, PhD
investigator title: Professor and Associate Director of Population Science
mesh term: Melanoma
mesh term: Skin Neoplasms
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Findings may be less generalizable to those with low sun protection behavior. We recruited from one state so participant pool may not represent the US population. SSE and sun protection were assessed using self-report. Sun content was in the last core and reviewed by fewer participants. Sample was primarily non-Hispanic white.
point of contact: 