Sun SensitivityNCT02177006
Helping Children be Safe Outdoors With Sun Protection
An observational study of Sun Sensitivity and Sun Protection, run by Northwestern University at 1 site in United States.
Trial summary
Childhood exposure to high levels of sunlight is a strong determinant of melanoma risk. Pediatric clinicians can provide important sun protection counseling. In 2003, the United States Preventive Services Task Force determined that clinician counseling has an effect on use of sunscreen for children but not for other… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sun Sensitivity, Sun Protection, Skin Cancer
- What is being tested?
- Sun Protection Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2014
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lake Forest Pediatric Associates clinics in Lake Bluff, IL, Lindenhurst, IL and Vernon Hills, IL
Who may be able to join
- Practice as a pediatrician, nurse practitioner, and/or nurse at an identified study site
- Are at least 18 years old
- Are able to complete the study procedures including answering questionnaires
- Are the parent of a 2-6 year old child
Who cannot join
- Not fluent in English
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611
About this study
Childhood exposure to high levels of sunlight is a strong determinant of melanoma risk. Pediatric clinicians can provide important sun protection counseling. In 2003, the United States Preventive Services Task Force determined that clinician counseling has an effect on use of sunscreen for children but not for other sun protection measures such as protective clothing, or reducing sun exposure. Regular sunscreen use prevents melanoma development in adults as well as nevi in children, but reliance on sunscreen as the only form of sun protection is problematic.
This novel research seeks to develop a sun protection program that is feasible for pediatric clinicians to deliver with patient-centered messages and systems to support program implementation in the clinical offices. The sun protection messages will enable behavioral change by the stakeholders (caregivers and children) that will reduce painful sunburns in the children and eventually reduce the incidence of melanoma. Testing the feasibility of delivering the intervention in a pediatric practice will enhance the sustainability of the intervention, and lead the way to dissemination of good practice.
Read more
This proposal seeks to develop and test an intervention that seeks to improve sun protection of young children. The intervention includes two phases:
Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory guidance sheet provided by the practice to caregivers of children 2-6 years of age.
Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported surveys
We hypothesize that redemption of the vouchers will be associated with the perception of the child having sun sensitive skin.
Read the detailed description
Phase 1:
The Lake Forest Pediatric Associates with pediatricians and nurse practitioners in Lake Bluff, IL, Lindenhurst, IL and Vernon Hills, IL have agreed to participate in the research. All members of this practice have appointments in the Department of Pediatrics at Northwestern Lake Forest Hospital.
We seek to test the feasibility of delivering the sun protection message by affixing vouchers to redeem a swim shirt to the sun protection tip sheet that will be delivered to the caregiver by the practitioners.
As part of the well child visit performed by the pediatric clinicians from Lake Forest Pediatric Associates, caregivers of children from 2-6 years old will receive a tip sheet with a voucher during the 13 weeks from June 1, 2014 until August 31, 2014. The research manager will be present at the clinic on pre-designated dates and times, during which she will be responsible for replenishing the research packet consisting of vouchers, tip sheet and survey, recording the numbers of the packets distributed in the prior week, and collecting the completed surveys.
Phase 2:
The survey will be labeled with a subject number identical to the serial number appearing on the swim shirt voucher. This system will allow us to determine the proportion of caregivers who receive a voucher, report intending to redeem it, and later redeem it. The survey will assess parental demographic information , history of sun sensitivity of the skin skin cancers, in addition to the caregivers' perception of their risk of developing skin cancer and confidence in knowing which sunscreen to use, the caregiver reports the children's demographic information and sun sensitivity of their skin, and the caregiver's intention to redeem the voucher. The voucher states that the swim shirt, which is received free of charge, typically retails for $15. Shipping will cost about $3. The swim shirts will be provided by the Pediatric Sun Protection Foundation.
The voucher will be redeemed online at www.SUNHERO.ORG. When the caregiver registers online, the first screen will ask the caregiver to provide the coupon code found on the voucher. This information will be entered into a database consisting solely of the subject number and the date the voucher is redeemed. The deidentified data from the first screen is transmitted to the research team at Northwestern. Then on the next screen, the caregiver is asked to provide the size of the swim shirt for the child, the preferred mailing address, and payment for mailing the swim shirt to the caregiver. The information on the second screen is not provided to the Northwestern research team.
- Conditions
- Sun Sensitivity, Sun Protection, Skin Cancer
- Being tested
- Sun Protection Program
- Medical subject headings
- Photosensitivity Disorders, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sun Protection ProgramBehavioural
The intervention includes two phases:
Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory guidance sheet provided by the practice to caregivers of children 2-6 years of age.
Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported surveys
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Caregivers of children 2-6 years of age Receives: Behavioral: Sun Protection Program | |
| Pediatric clinicians | Pediatricians and nurse practitioners at Lake Forest Pediatric Associates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed caregiver self-reported surveys
Measured: Baseline
Secondary outcomes (1)
Percentage of online redemption of swim shirt vouchers in comparison with the caregiver self-reported surveys
Measured: Baseline, up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
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 Sun SensitivityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June K Robinson, MD, Principal investigator, Northwestern UniversityDennis P West, PhD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177006
- Sponsor's protocol ID
- STU00094207
- Status last verified
- Feb 2024
- First submitted
- 24 Jun 2014
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhave N, Reidy K, Randall Kinsella T, Brodsky AL, Robinson JK (2014) Caregivers' Response to Pediatric Clinicians Sun Protection Anticipatory Guidance: Sun Protective Swim Shirts for 2-6 year old Children. J Community Med Health Educ 4: 316. doi:10.4172/2161-0711.1000316
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Children be Safe Outdoors With Sun Protection
- ClinicalTrials.gov ID
- NCT02177006
- Acronym / sponsor ID
- STU00094207
- Conditions
- Sun Sensitivity, Sun Protection, Skin Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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.
Childhood exposure to high levels of sunlight is a strong determinant of melanoma risk. Pediatric clinicians can provide important sun protection counseling. In 2003, the United States Preventive Services Task Force determined that clinician counseling has an effect on use of sunscreen for children but not for other sun protection measures such as protective clothing, or reducing sun exposure. Regular sunscreen use prevents melanoma development in adults as well as nevi in children, but reliance on sunscreen as the only form of sun protection is problematic.
This novel research seeks to develop a sun protection program that is feasible for pediatric clinicians to deliver with patient-centered messages and systems to support program implementation in the clinical offices. The sun protection messages will enable behavioral change by the stakeholders (caregivers and children) that will reduce painful sunburns in the children and eventually reduce the incidence of melanoma. Testing the feasibility of delivering the intervention in a pediatric practice will enhance the sustainability of the intervention, and lead the way to dissemination of good practice.
This proposal seeks to develop and test an intervention that seeks to improve sun protection of young children. The intervention includes two phases:
Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory guidance sheet provided by the practice to caregivers of children 2-6 years of age.
Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported surveys
We hypothesize that redemption of the vouchers will be associated with the perception of the child having sun sensitive skin.
Detailed description
Phase 1:
The Lake Forest Pediatric Associates with pediatricians and nurse practitioners in Lake Bluff, IL, Lindenhurst, IL and Vernon Hills, IL have agreed to participate in the research. All members of this practice have appointments in the Department of Pediatrics at Northwestern Lake Forest Hospital.
We seek to test the feasibility of delivering the sun protection message by affixing vouchers to redeem a swim shirt to the sun protection tip sheet that will be delivered to the caregiver by the practitioners.
As part of the well child visit performed by the pediatric clinicians from Lake Forest Pediatric Associates, caregivers of children from 2-6 years old will receive a tip sheet with a voucher during the 13 weeks from June 1, 2014 until August 31, 2014. The research manager will be present at the clinic on pre-designated dates and times, during which she will be responsible for replenishing the research packet consisting of vouchers, tip sheet and survey, recording the numbers of the packets distributed in the prior week, and collecting the completed surveys.
Phase 2:
The survey will be labeled with a subject number identical to the serial number appearing on the swim shirt voucher. This system will allow us to determine the proportion of caregivers who receive a voucher, report intending to redeem it, and later redeem it. The survey will assess parental demographic information , history of sun sensitivity of the skin skin cancers, in addition to the caregivers' perception of their risk of developing skin cancer and confidence in knowing which sunscreen to use, the caregiver reports the children's demographic information and sun sensitivity of their skin, and the caregiver's intention to redeem the voucher. The voucher states that the swim shirt, which is received free of charge, typically retails for $15. Shipping will cost about $3. The swim shirts will be provided by the Pediatric Sun Protection Foundation.
The voucher will be redeemed online at www.SUNHERO.ORG. When the caregiver registers online, the first screen will ask the caregiver to provide the coupon code found on the voucher. This information will be entered into a database consisting solely of the subject number and the date the voucher is redeemed. The deidentified data from the first screen is transmitted to the research team at Northwestern. Then on the next screen, the caregiver is asked to provide the size of the swim shirt for the child, the preferred mailing address, and payment for mailing the swim shirt to the caregiver. The information on the second screen is not provided to the Northwestern research team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Behavioral: Sun Protection ProgramCaregivers of children 2-6 years of age |
| Pediatric clinicians | – | –Pediatricians and nurse practitioners at Lake Forest Pediatric Associates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lake Forest Pediatric Associates clinics in Lake Bluff, IL, Lindenhurst, IL and Vernon Hills, IL
Key inclusion criteria (4 listed)
- Practice as a pediatrician, nurse practitioner, and/or nurse at an identified study site
- Are at least 18 years old
- Are able to complete the study procedures including answering questionnaires
- Are the parent of a 2-6 year old child
Key exclusion criteria (2 listed)
- Not fluent in English
- Not fluent in English
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 |
|---|---|---|
| Sun Protection ProgramThe intervention includes two phases: Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory guidance sheet provided by the practice to caregivers of children 2-6 years of age. Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported surveys | Behavioural | Caregivers |
Primary outcome
Number of completed caregiver self-reported surveys
Time frame: Baseline
1 secondary outcome
Percentage of online redemption of swim shirt vouchers in comparison with the caregiver self-reported surveys
Time frame: Baseline, up to 13 weeks
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 28 Feb 2024.
- Results publicationBhave N, Reidy K, Randall Kinsella T, Brodsky AL, Robinson JK (2014) Caregivers' Response to Pediatric Clinicians Sun Protection Anticipatory Guidance: Sun Protective Swim Shirts for 2-6 year old Children. J Community Med Health Educ 4: 316. doi:10.4172/2161-0711.1000316
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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.
June K Robinson, MD principal investigator
Northwestern University
Dennis P West, PhD study director
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sun Sensitivity and Sun Protection, run by Northwestern University 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 4 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
Number of completed caregiver self-reported surveys (time frame: Baseline). 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 NCT02177006, 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 28 Feb 2024.