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UV Dosimetry Feedback in NMSC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757663
Recruitment Status : Withdrawn (Study closed)
First Posted : November 29, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-Melanoma Skin Cancer Behavioral: UV Counseling Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: UV Dosimeter
UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.
 Behavioral: UV Counseling
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.


Outcome Measures
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Primary Outcome Measures :
  1. Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure [ Time Frame: Start of study to end of study, up to 3 months ]
    Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is

  2. Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure [ Time Frame: Start of study to end of study, up to 3 months ]
    Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it


Secondary Outcome Measures :
  1. Behavioral Intervention and immediate follow-up [ Time Frame: Start of study to end of study, up to 3 months ]
    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.

  2. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between ages 18 and 50.
  • Must be diagnosed with non-melanoma skin cancer.

Exclusion Criteria:

  • Patients, who at the discretion of the clinician, are too ill or sick.
  • Non-English speaking patients.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757663


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Myles Cockburn, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03757663    
Other Study ID Numbers: 17-2134.cc
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
UV Dosimetry
UV Exposure
Behavioral
 Social Cognitive Theory
Self-Regulation
Self-Efficacy
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases