Non-Melanoma Skin CancerNCT03757663
UV Dosimetry Feedback in NMSC Patients
A study testing UV Counseling in people with Non-Melanoma Skin Cancer, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Non-Melanoma Skin Cancer
- What is being tested?
- UV Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between ages 18 and 50.
- Must be diagnosed with non-melanoma skin cancer.
Who cannot join
- Patients, who at the discretion of the clinician, are too ill or sick.
- Non-English speaking patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients
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
Read the 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.
- Conditions
- Non-Melanoma Skin Cancer
- Being tested
- UV Counseling
- Keywords
- UV Dosimetry, UV Exposure, Behavioral, Social Cognitive Theory, Self-Regulation, Self-Efficacy
- Medical subject headings
- Behavior, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| UV Dosimeter | Experimental | UV Dosimeter will measure participants' UV exposure for two separate 3-week periods. Receives: Behavioral: UV Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Start of study to end of study, up to 3 months
Secondary outcomes (2)
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.
Measured: Start of study to end of study, up to 3 months
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.
Measured: Start of study to end of study, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start12 Mar 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Why it stopped: Study closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Melanoma Skin CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myles Cockburn, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757663
- Sponsor's protocol ID
- 17-2134.cc
- Status last verified
- Sep 2019
- First submitted
- 26 Nov 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients
- ClinicalTrials.gov ID
- NCT03757663
- Acronym / sponsor ID
- 17-2134.cc
- Conditions
- Non-Melanoma Skin Cancer
- Keywords
- UV Dosimetry, UV Exposure, Behavioral, Social Cognitive Theory, Self-Regulation, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| UV Dosimeter | Experimental | Behavioral: UV CounselingUV Dosimeter will measure participants' UV exposure for two separate 3-week periods. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients between ages 18 and 50.
- Must be diagnosed with non-melanoma skin cancer.
Key exclusion criteria (2 listed)
- Patients, who at the discretion of the clinician, are too ill or sick.
- Non-English speaking patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UV CounselingParticipants 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. | Behavioural | UV Dosimeter |
Primary outcome
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
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
2 secondary outcomes
Behavioral Intervention and immediate follow-up
Time frame: Start of study to end of study, up to 3 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myles Cockburn, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UV Counseling in people with Non-Melanoma Skin Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.