UV Dosimetry Feedback in NMSC Patients

NCT03757663 | Withdrawn DMC

• 1 other identifier: 17-2134.cc
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Melanoma Skin Cancer

Keywords

UV Dosimetry; UV Exposure; Behavioral; Social Cognitive Theory; Self-Regulation; Self-Efficacy

Outcome Measures

Primary Outcomes (2)

• 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

  Start of study to end of study, up to 3 months

• 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

  Start of study to end of study, up to 3 months

Secondary Outcomes (2)

• Behavioral Intervention and immediate follow-up

  Start of study to end of study, up to 3 months

• Long Term Follow Up - longitudinal change in sun exposure based on dosimetry

  Start of study to end of study, up to 3 months

Study Arms (1)

UV Dosimeter

EXPERIMENTAL

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

Behavioral: UV Counseling

Interventions

UV Counseling BEHAVIORAL

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.

UV Dosimeter

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients, who at the discretion of the clinician, are too ill or sick.
• Non-English speaking patients.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Behavior; Self-Control

Condition Hierarchy (Ancestors)

Social Behavior

Study Officials

• Myles Cockburn, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 29, 2018
• Study Start: March 12, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

US (1)