This trial studies the effect of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in decreasing reported child sunburn occurrence. The FLARE intervention provides educational information that may help children and families do things that could prevent melanoma, like getting fewer sunburns.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04201223.
PRIMARY OBJECTIVES:
I. Conduct a randomized controlled trial (RCT) with 375 parent-child dyads to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in decreasing reported child sunburn occurrence pre- to post-intervention and at one-year follow-up.
II. Identify child and parent moderators of intervention effects to understand for whom interventions provide the most benefit and to guide future tailoring of FLARE for different subgroups.
III. Examine how parent-child reciprocal influences in intervention mechanisms affect child sun protection.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive the FLARE intervention consisting of sun protection information, developmentally-appropriate information on the child’s elevated risk for melanoma, strategies to overcome common barriers to sun protection, and a structured problem-solving strategy for addressing their unique barriers to sun protection for 3 sessions over 30 minutes each every 2 weeks.
ARM II: Participants receive standard of care education consisting of information on child sun protection for 3 sessions over 30 minutes each every 2 weeks.
After completion of study, participants are followed up at 4 and 8 weeks, and at 1 year.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorYelena Ping Wu
