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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03757663
Other study ID # 17-2134.cc
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 12, 2018
Est. completion date August 30, 2019

Study information

Verified date September 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. Start of study to end of study, up to 3 months
Secondary 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. Start of study to end of study, up to 3 months
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