<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/NCT03757663</url>
  </required_header>
  <id_info>
    <org_study_id>17-2134.cc</org_study_id>
    <nct_id>NCT03757663</nct_id>
  </id_info>
  <brief_title>UV Dosimetry Feedback in NMSC Patients</brief_title>
  <official_title>UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to characterize UV exposures among NMSC patients (those with a history of&#xD;
      skin cancer) and to pilot an innovative behavioral intervention to decrease modifiable UV&#xD;
      exposures. It will use UV dosimeters to objectively measure UV exposure and provide time and&#xD;
      activity specific UV data on an individual level. These data will be used to develop a&#xD;
      targeted and personalized behavioral feedback plan with counseling aimed at effective sun&#xD;
      exposure behavior change&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will focus on helping to prevent NMSC and its associated morbidity through learning&#xD;
      when patients are unintentionally exposed to extreme UV radiation. It will then help to&#xD;
      create manageable and realistic behavioral interventions to reduce exposure, while also&#xD;
      educating patients of the dangers of abundant sun exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study closed&#xD;
  </why_stopped>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Each participant will self-report skin protective behaviors and attitudes before wearing a UV dosimeter for 3 weeks. After the wear period, the study team provides feedback based on UV exposure. The participant will then wear the device again for 3 weeks.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure</measure>
    <time_frame>Start of study to end of study, up to 3 months</time_frame>
    <description>Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure</measure>
    <time_frame>Start of study to end of study, up to 3 months</time_frame>
    <description>Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral Intervention and immediate follow-up</measure>
    <time_frame>Start of study to end of study, up to 3 months</time_frame>
    <description>Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long Term Follow Up - longitudinal change in sun exposure based on dosimetry</measure>
    <time_frame>Start of study to end of study, up to 3 months</time_frame>
    <description>Track the longitudinal change in sun exposure comparing baseline UV dosimetry measurements to 3 month follow up dosimetry measurements to determine if the changes observed in outcome 3 are maintained.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-Melanoma Skin Cancer</condition>
  <arm_group>
    <arm_group_label>UV Dosimeter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>UV Counseling</intervention_name>
    <description>Participants will self-report their knowledge and attitudes related to UV exposure. They will then wear a dosimeter for 3 weeks. After, the study team will counsel the participants on their UV levels and exposure, creating a personal plan and advice for avoiding sun exposure before letting the participants wear the dosimeter for an additional 3 weeks.</description>
    <arm_group_label>UV Dosimeter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between ages 18 and 50.&#xD;
&#xD;
          -  Must be diagnosed with non-melanoma skin cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients, who at the discretion of the clinician, are too ill or sick.&#xD;
&#xD;
          -  Non-English speaking patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myles Cockburn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>UV Dosimetry</keyword>
  <keyword>UV Exposure</keyword>
  <keyword>Behavioral</keyword>
  <keyword>Social Cognitive Theory</keyword>
  <keyword>Self-Regulation</keyword>
  <keyword>Self-Efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03757663
org study id: 17-2134.cc
nct id: NCT03757663
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to characterize UV exposures among NMSC patients (those with a history of
      skin cancer) and to pilot an innovative behavioral intervention to decrease modifiable UV
      exposures. It will use UV dosimeters to objectively measure UV exposure and provide time and
      activity specific UV data on an individual level. These data will be used to develop a
      targeted and personalized behavioral feedback plan with counseling aimed at effective sun
      exposure behavior change
The study will focus on helping to prevent NMSC and its associated morbidity through learning
      when patients are unintentionally exposed to extreme UV radiation. It will then help to
      create manageable and realistic behavioral interventions to reduce exposure, while also
      educating patients of the dangers of abundant sun exposure.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Each participant will self-report skin protective behaviors and attitudes before wearing a UV dosimeter for 3 weeks. After the wear period, the study team provides feedback based on UV exposure. The participant will then wear the device again for 3 weeks.
primary purpose: Prevention
masking: None (Open Label)
measure: Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure
time frame: Start of study to end of study, up to 3 months
description: Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is
measure: Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure
time frame: Start of study to end of study, up to 3 months
description: Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it
measure: Behavioral Intervention and immediate follow-up
time frame: Start of study to end of study, up to 3 months
description: Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.
measure: Long Term Follow Up - longitudinal change in sun exposure based on dosimetry
time frame: Start of study to end of study, up to 3 months
description: Track the longitudinal change in sun exposure comparing baseline UV dosimetry measurements to 3 month follow up dosimetry measurements to determine if the changes observed in outcome 3 are maintained.
arm group label: UV Dosimeter
arm group type: Experimental
description: UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.
intervention type: Behavioral
intervention name: UV Counseling
description: Participants will self-report their knowledge and attitudes related to UV exposure. They will then wear a dosimeter for 3 weeks. After, the study team will counsel the participants on their UV levels and exposure, creating a personal plan and advice for avoiding sun exposure before letting the participants wear the dosimeter for an additional 3 weeks.
arm group label: UV Dosimeter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Myles Cockburn, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Skin Neoplasms