FLARE Intervention for Melanoma Prevention

(FLARE Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Non-English speakers, Developmental delay, CDKN2A/p16 testing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

762 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.

Research Team

Yelena Wu, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for melanoma survivors aged 18+ and their children aged 8-17. Eligible adults must have a history of melanoma and at least one child who can join the study with them. Children qualify if they've had a sunburn in the past year. Families cannot join if they've been tested for CDKN2A/p16 mutations, don't speak English, or have developmental delays.

Inclusion Criteria

I am over 18, have had melanoma, and have a child aged 8-17 who can join the trial with me.

My child is 8-17, had a sunburn last year, and I have a history of melanoma.

Exclusion Criteria

I do not have a developmental delay that prevents participation.

I have not been tested for the CDKN2A/p16 mutation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parent-child dyads participate in three bi-weekly live intervention sessions with an interventionist

6 weeks

3 visits (virtual)

Post-Intervention Assessment

Participants complete post-intervention assessments to evaluate changes in sunburn occurrence and preventive behaviors

8 weeks

Follow-up

Participants are monitored for long-term changes in sunburn occurrence and preventive behaviors

1 year

Treatment Details

Interventions

• FLARE Intervention

Trial Overview The FLARE intervention aims to improve melanoma preventive behaviors among parent-child pairs where the parent is a melanoma survivor. Participants are randomly placed into two groups: one receives FLARE education while the other gets standard advice, followed by bi-weekly sessions and quarterly reminders over a year.

Participant Groups

Group I: FLARE Intervention Experimental Treatment 1 Intervention

Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.

Group II: Standard Education Active Control 1 Intervention

Participants will be randomized to receive information on child sun protection that is publicly available.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+