MelanomaNCT03745872
SunSmart Intervention in Schools
A study testing Knowledge Assessment in people with Melanoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
A prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Knowledge Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 30 Aug 2021
- 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any children between grades 4 and 8 enrolled in one of the participating schools.
Who cannot join
- No exclusions, but children or their parents may opt out of participating.
Trial locations and contacts
1 site in 1 country.
About this study
A prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention.
Read the detailed description
This study aims to demonstrate that learning about sun exposure using a more classroom-based intervention will motivate classroom students to reduce exposure at a critical life period and will create lifetime learned sun exposure behaviors. Students' sun exposure behaviors will be assessed prior to the educational intervention. The educational intervention consists of three educational sessions and one lab lesson. At the conclusion of the intervention, students' sun exposure behaviors will be assessed again via a post-intervention questionnaire.
- Conditions
- Melanoma
- Being tested
- Knowledge Assessment
- Keywords
- Sunscreen, Sun Exposure, Behaviors, Baseline Assessments, Follow-up Assessments, Knowledge
- Medical subject headings
- Melanoma, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge AssessmentBehavioural
Students participating in this study will receive a pre test, instruction regarding sun safety, and a post test.
| Study group | Role | What they receive |
|---|---|---|
| Testing | Experimental | This is a preventative study model. All students who choose to participate will receive a pre and post test regarding their sun exposure behaviors and knowledge on sun exposure risk. Receives: Behavioral: Knowledge Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sun Exposure Knowledge
Determining children's knowledge of sun exposure risk through a self-completed questionnaire
Measured: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Sun Exposure Attitudes
Determining children's attitude toward sun exposure through a self-completed questionnaire
Measured: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Sun Exposure Behavior
Determining children's behavior toward sun exposure through a self-completed questionnaire
Measured: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Secondary outcomes (3)
Mediators of Program Effects: Attitudes
Assessing children's attitude toward sun exposure through a self-completed questionnaire
Measured: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Mediators of Program Effects: Norms
Determining children's understanding of social norms regarding tanning and sun protection through a self-completed questionnaire
Measured: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Mediators of Program Effects: Personal Agency
Determining children's understanding of behavioral control regarding sun protection through a self-completed questionnaire
Measured: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start26 Sep 2017
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- All students who participate in this study will be given a pre test, instruction regarding sun exposure and a post test to determine their sun exposure behaviors and knowledge of sun exposure risks.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelinn Borrayo, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745872
- Sponsor's protocol ID
- 17-0667.cc
- Status last verified
- Jan 2022
- First submitted
- 15 Nov 2018
- Last updated
- 4 Jan 2022
- 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 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SunSmart Intervention in Schools
- ClinicalTrials.gov ID
- NCT03745872
- Acronym / sponsor ID
- 17-0667.cc
- Conditions
- Melanoma
- Keywords
- Sunscreen, Sun Exposure, Behaviors, Baseline Assessments, Follow-up Assessments, Knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 19 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.
A prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention.
Detailed description
This study aims to demonstrate that learning about sun exposure using a more classroom-based intervention will motivate classroom students to reduce exposure at a critical life period and will create lifetime learned sun exposure behaviors. Students' sun exposure behaviors will be assessed prior to the educational intervention. The educational intervention consists of three educational sessions and one lab lesson. At the conclusion of the intervention, students' sun exposure behaviors will be assessed again via a post-intervention questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All students who participate in this study will be given a pre test, instruction regarding sun exposure and a post test to determine their sun exposure behaviors and knowledge of sun exposure risks.
| Arm | Type | Receives |
|---|---|---|
| Testing | Experimental | Behavioral: Knowledge AssessmentThis is a preventative study model. All students who choose to participate will receive a pre and post test regarding their sun exposure behaviors and knowledge on sun exposure risk. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any children between grades 4 and 8 enrolled in one of the participating schools.
Key exclusion criteria (1 listed)
- No exclusions, but children or their parents may opt out of participating.
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 |
|---|---|---|
| Knowledge AssessmentStudents participating in this study will receive a pre test, instruction regarding sun safety, and a post test. | Behavioural | Testing |
Primary outcome
Sun Exposure Knowledge
Time frame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Determining children's knowledge of sun exposure risk through a self-completed questionnaire
Sun Exposure Attitudes
Time frame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Determining children's attitude toward sun exposure through a self-completed questionnaire
Sun Exposure Behavior
Time frame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Determining children's behavior toward sun exposure through a self-completed questionnaire
3 secondary outcomes
Mediators of Program Effects: Attitudes
Time frame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Mediators of Program Effects: Norms
Time frame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Mediators of Program Effects: Personal Agency
Time frame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
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 4 Jan 2022.
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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.
Evelinn Borrayo, 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 Knowledge Assessment in people with Melanoma, 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 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 4 Jan 2022. 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 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?
Sun Exposure Knowledge (time frame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years). The study lists 3 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 4 Jan 2022.