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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.

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

FLARE Trial 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.Check my eligibility

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.See study design

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.

FLARE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

FLARE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Child Sunburn Occurrence Assessed Via Sun Habits Survey

Secondary outcome measures

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

FLARE 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,095 Previous Clinical Trials

1,774,823 Total Patients Enrolled

14 Trials studying Melanoma

564 Patients Enrolled for Melanoma

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

109,693 Total Patients Enrolled

3 Trials studying Melanoma

2,627 Patients Enrolled for Melanoma

Yelena Wu, PhDPrincipal InvestigatorUniversity of Utah

5 Previous Clinical Trials

30,852 Total Patients Enrolled

1 Trials studying Melanoma

42 Patients Enrolled for Melanoma

Media Library

FLARE Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04201223 — N/A

Melanoma Research Study Groups: FLARE Intervention, Standard Education

Melanoma Clinical Trial 2023: FLARE Intervention Highlights & Side Effects. Trial Name: NCT04201223 — N/A

FLARE Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04201223 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for participants in this medical trial?

"According to clinicaltrials.gov, this trial is no longer accepting participants as the initial post date was April 7th 2020 and it has not been updated since May 16th 2022. There are still 801 active trials looking for volunteers at present though."

Answered by AI

Does this investigation encompass participants aged eighty or above?

"Those that wish to participate in this research must be between 8 and 110 years of age. There are 97 trials for children, and 752 studies available for the elderly."

Answered by AI

Are there any restrictions on who is eligible to join this research study?

"The present research is seeking 750 enrollees aged 8-110 who have offspring. In addition to the aforementioned, prospective participants must fulfill the following conditions: possess a prior diagnosis of melanoma at any point during their life; sustain one or more sunburns in the past year; be over 18 years old and accompanied by an eligible child between 8-17 for parental studies; or conversely, themselves fall within that age range with a parent suffering from melanoma participating together with them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Family Lifestyles, Actions, and Risk Education Intervention: Version 2

Yelena Wu 2020. "Family Lifestyles, Actions, and Risk Education Intervention: Version 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04201223.

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