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UV Dosimetry Feedback in NMSC Patients

Primary Purpose

Non-Melanoma Skin Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UV Counseling
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Melanoma Skin Cancer focused on measuring UV Dosimetry, UV Exposure, Behavioral, Social Cognitive Theory, Self-Regulation, Self-Efficacy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UV Dosimeter

Arm Description

UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.

Outcomes

Primary Outcome Measures

Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure
Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is
Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure
Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it

Secondary Outcome Measures

Behavioral Intervention and immediate follow-up
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.
Long Term Follow Up - longitudinal change in sun exposure based on dosimetry
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.

Full Information

First Posted
November 26, 2018
Last Updated
September 4, 2019
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03757663
Brief Title
UV Dosimetry Feedback in NMSC Patients
Official Title
UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study closed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Melanoma Skin Cancer
Keywords
UV Dosimetry, UV Exposure, Behavioral, Social Cognitive Theory, Self-Regulation, Self-Efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UV Dosimeter
Arm Type
Experimental
Arm Description
UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.
Intervention Type
Behavioral
Intervention Name(s)
UV Counseling
Intervention 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.
Primary Outcome Measure Information:
Title
Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure
Description
Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is
Time Frame
Start of study to end of study, up to 3 months
Title
Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure
Description
Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it
Time Frame
Start of study to end of study, up to 3 months
Secondary Outcome Measure Information:
Title
Behavioral Intervention and immediate follow-up
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.
Time Frame
Start of study to end of study, up to 3 months
Title
Long Term Follow Up - longitudinal change in sun exposure based on dosimetry
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.
Time Frame
Start of study to end of study, up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myles Cockburn, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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UV Dosimetry Feedback in NMSC Patients

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