Skin NeoplasmNCT04176237
School-based Randomized Trial of SunSmart Interventions
A study testing UV Dosimetry Laboratory in people with Skin Neoplasm, run by University of Southern California.
Trial summary
The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin Neoplasm
- What is being tested?
- UV Dosimetry Laboratory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,750 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Nov 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child in classrooms from selected schools in the Los Angeles metropolitan area.
Who cannot join
- All children will participate in the educational activities, unless they opt out of pre- and post-test questionnaires or are absent from school for any of the education sessions.
About this study
Official title: A Novel Intervention to Improve Sun Exposure Awareness and Behavior in Children
The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure.
Read the detailed description
Childhood sun exposure not only increases melanoma risk, but may establish lifetime patterns of exposure and protection. Individuals receive a substantial proportion of lifetime exposure to ultraviolet radiation (UVR) during childhood, and severe sunburns before age 20 may increase lifetime risk of developing melanoma. The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure. Building on the previously existing SunSmart program the investigators have been conducting in 20 local Los Angeles schools in partnership with USC's Joint Education Project (JEP), this study will implement a Randomized Controlled Trial among 5th-6th graders (aged 10-14), comparing this new education-feedback approach to the existing SunSmart education-only program, testing knowledge, attitudes and behavior before and after the intervention. In a subset of students, the investigators will collect real time UV exposure data using personal dosimetry as a Gold Standard measure of change in UV exposure behaviors. The study design randomizes at least 18 schools to 9 intervention or 9 non-intervention (control) schools, and students within each school all have pre- and post-tests. The investigators will also select classrooms from each school across conditions to have students wear dosimeters pre- and post- Intervention/Control. Using a hierarchical cluster analysis with the school unit taken as random and students as repeated measures within school, the investigators will test the primary hypothesis that improvements in sun exposure behaviors are significantly higher than baseline at post-test in the Intervention than Control group, and that this may even occur without significant differences in sun exposure knowledge and attitudes between the two groups. The investigators will additionally test the hypothesis that total UV exposures obtained from UV dosimetry are significantly lower than baseline in the Intervention than control group after Intervention.
- Conditions
- Skin Neoplasm
- Being tested
- UV Dosimetry Laboratory
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV Dosimetry LaboratoryOther
The UV Dosimetry Laboratory is a one hour lesson that incorporates science and health education - kids hypothesize what UV levels will be around the school yard, go and measure UV, review their results, and then come up with a SunSmart plan for playing in the school yard.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Schools receive 3 one hour lessons on sun safety, followed by a 1 hour UV dosimtery laboratory session. Receives: Other: UV Dosimetry Laboratory |
| Control | No intervention | Schools receive 3 one hour lessons on sun safety. |
| Observation | No intervention | Schools do not receive any lessons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sun exposure behavior
Self reported change in sun exposure behavior using 4 questions in a self-completed questionnaire
Measured: One week after completion of education activities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Jan 2014
- Primary completion10 Jan 2017
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin NeoplasmStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Schools are randomized to receive one of three conditions: (1) Intervention (the expanded SunSmart program); (2) Control (regular SunSmart program); (3) Observation only. Schools in groups (2) and (3) receive the expanded SunSmart program at the conclusion of their participation in data collection.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Myles Cockburn, University of Southern California
- Investigators
- Myles G Cockburn, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176237
- Sponsor's protocol ID
- HS-11-00677
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller KA, Huh J, Piombo SE, Richardson JL, Harris SC, Peng DH, Cockburn MG. Sun protection changes among diverse elementary schoolchildren participating in a sun safety intervention: A latent transition analysis of a randomized controlled trial. Prev Med. 2021 Aug;149:106601. doi: 10.1016/j.ypmed.2021.106601. Epub 2021 May 7.
PubMed 33971211
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Intervention to Improve Sun Exposure Awareness and Behavior in Children
- ClinicalTrials.gov ID
- NCT04176237
- Acronym / sponsor ID
- HS-11-00677
- Conditions
- Skin Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,750 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 25 Nov 2019 (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.
The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure.
Detailed description
Childhood sun exposure not only increases melanoma risk, but may establish lifetime patterns of exposure and protection. Individuals receive a substantial proportion of lifetime exposure to ultraviolet radiation (UVR) during childhood, and severe sunburns before age 20 may increase lifetime risk of developing melanoma. The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure. Building on the previously existing SunSmart program the investigators have been conducting in 20 local Los Angeles schools in partnership with USC's Joint Education Project (JEP), this study will implement a Randomized Controlled Trial among 5th-6th graders (aged 10-14), comparing this new education-feedback approach to the existing SunSmart education-only program, testing knowledge, attitudes and behavior before and after the intervention. In a subset of students, the investigators will collect real time UV exposure data using personal dosimetry as a Gold Standard measure of change in UV exposure behaviors. The study design randomizes at least 18 schools to 9 intervention or 9 non-intervention (control) schools, and students within each school all have pre- and post-tests. The investigators will also select classrooms from each school across conditions to have students wear dosimeters pre- and post- Intervention/Control. Using a hierarchical cluster analysis with the school unit taken as random and students as repeated measures within school, the investigators will test the primary hypothesis that improvements in sun exposure behaviors are significantly higher than baseline at post-test in the Intervention than Control group, and that this may even occur without significant differences in sun exposure knowledge and attitudes between the two groups. The investigators will additionally test the hypothesis that total UV exposures obtained from UV dosimetry are significantly lower than baseline in the Intervention than control group after Intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Schools are randomized to receive one of three conditions: (1) Intervention (the expanded SunSmart program); (2) Control (regular SunSmart program); (3) Observation only. Schools in groups (2) and (3) receive the expanded SunSmart program at the conclusion of their participation in data collection.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: UV Dosimetry LaboratorySchools receive 3 one hour lessons on sun safety, followed by a 1 hour UV dosimtery laboratory session. |
| Control | No intervention | –Schools receive 3 one hour lessons on sun safety. |
| Observation | No intervention | –Schools do not receive any lessons. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Child in classrooms from selected schools in the Los Angeles metropolitan area.
Key exclusion criteria (1 listed)
- All children will participate in the educational activities, unless they opt out of pre- and post-test questionnaires or are absent from school for any of the education sessions.
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 Dosimetry LaboratoryThe UV Dosimetry Laboratory is a one hour lesson that incorporates science and health education - kids hypothesize what UV levels will be around the school yard, go and measure UV, review their results, and then come up with a SunSmart plan for playing in the school yard. | Other | Intervention |
Primary outcome
Change in sun exposure behavior
Time frame: One week after completion of education activities
Self reported change in sun exposure behavior using 4 questions in a self-completed questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Derived from this study: PubMed 33971211Miller KA, Huh J, Piombo SE, Richardson JL, Harris SC, Peng DH, Cockburn MG. Sun protection changes among diverse elementary schoolchildren participating in a sun safety intervention: A latent transition analysis of a randomized controlled trial. Prev Med. 2021 Aug;149:106601. doi: 10.1016/j.ypmed.2021.106601. Epub 2021 May 7.
- Individual participant dataSharing planned: No
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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 G Cockburn, PhD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing UV Dosimetry Laboratory in people with Skin Neoplasm, run by University of Southern California.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in sun exposure behavior (time frame: One week after completion of education activities). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176237, which also lists 1 linked publication.
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 27 Nov 2019.