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FLARE Intervention for Melanoma Prevention (FLARE Trial)

N/A

Waitlist Available

Led By Yelena Wu, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults are eligible for this trial if they are at least 18 years old and have been diagnosed with melanoma at any time in their life and have at least one biological child between the ages of 8-17 years who is able to participate in the trial with them.

Must not have

Adults and children will be excluded from participation if they received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p16.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline assessment (wk 0), session 3 (wk 5-6), post-assessment 1 (wk 8-11), post-assessment 2 (wk 12-15), 1-year follow-up (wk 52)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the Family Lifestyles, Actions, and Risk Education (FLARE) intervention can help improve melanoma preventive behaviors in parent-child dyads (consisting of survivors of melanoma and their children). If you enroll, you and your child will participate for just over 1 year, attending three live intervention sessions and receiving quarterly boosters via text or email.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on educational interventions rather than medical treatments, there are no direct side effects from drugs or procedures. However, participants may experience stress or anxiety related to discussions about health risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline assessment (wk 0), session 3 (wk 5-6), post-assessment 1 (wk 8-11), post-assessment 2 (wk 12-15), 1-year follow-up (wk 52)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline assessment (wk 0), session 3 (wk 5-6), post-assessment 1 (wk 8-11), post-assessment 2 (wk 12-15), 1-year follow-up (wk 52)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline assessment (wk 0), session 3 (wk 5-6), post-assessment 1 (wk 8-11), post-assessment 2 (wk 12-15), 1-year follow-up (wk 52) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Child Sunburn Occurrence Assessed Via Sun Habits Survey

Secondary study objectives

Long Pants/Skirt Behavior Changes Assessed Via Sun Habits Survey

Long Sleeved Shirt Behavior Changes Assessed Via Sun Habits Survey

Peak Hours Behavior Changes Assessed Via Sun Habits Survey

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FLARE InterventionExperimental Treatment1 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 EducationActive Control1 Intervention

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

0 / 2Eligibility criteria met