Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02177006 |
| Other study ID # |
STU00094207 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2014 |
| Est. completion date |
September 2014 |
Study information
| Verified date |
February 2024 |
| Source |
Northwestern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
