NCT02177006

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

June 24, 2014

Last Update Submit

February 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of completed caregiver self-reported surveys

    Baseline

Secondary Outcomes (1)

  • Percentage of online redemption of swim shirt vouchers in comparison with the caregiver self-reported surveys

    Baseline, up to 13 weeks

Study Arms (2)

Caregivers

Caregivers of children 2-6 years of age

Behavioral: Sun Protection Program

Pediatric clinicians

Pediatricians and nurse practitioners at Lake Forest Pediatric Associates

Interventions

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

Caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lake Forest Pediatric Associates clinics in Lake Bluff, IL, Lindenhurst, IL and Vernon Hills, IL

You may qualify if:

  • Practice as a pediatrician, nurse practitioner, and/or nurse at an identified study site

You may not qualify if:

  • Not fluent in English
  • 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
  • Not fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Photosensitivity DisordersSkin Neoplasms

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesNeoplasms by SiteNeoplasms

Study Officials

  • June K Robinson, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
  • Dennis P West, PhD

    Northwestern University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Dermatology

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 27, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations