MelanomaFLARENCT04201223

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

A study testing FLARE Intervention in people with Melanoma and Child, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 8 to 110 yearsHealthy volunteers can take part
Conditions the study is for: Melanoma, Child
What is being tested?: FLARE Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 752 participants
Where: 1 siteUnited States
Study dates: 7 Apr 2020to 28 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 110 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.
Children are eligible to participate with their parent if they:
Are between the ages of 8-17 years AND
Had at least 1 sunburn in the last 12 months AND
Have at least one biological parent with a history of melanoma who can participate in the trial with them.

Who cannot join

Adults and children will be excluded from participation if they meet any of the following:
Do not speak English
Are unable to participate due to developmental delay
Received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p16.
Enrolled in a study led by an investigator at another institution, which also focuses on improving skin cancer prevention behaviors and utilizes the Utah Cancer Registry for study recruitment.
Have only a history of ocular melanoma

Trial locations and contacts

1 site in 1 country.

United States1 site

Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: The FLARE Skin Cancer Prevention Intervention for Children of Melanoma Survivors

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.

Read the detailed description

Enrollment

After parent-child dyads complete screening and informed consent/assent procedures, participants will be invited to complete an online baseline assessment. Following the baseline assessment, dyads will be randomized to receive either the FLARE intervention or standard education. After randomization, each dyad will receive a unique log-in to a secure study website that will be used to review didactic materials prior to each intervention session.

Intervention Sessions

Dyads will meet with an interventionist via remotely-delivered live session for their three intervention sessions. Intervention sessions will be scheduled every two weeks. After completion of the last remotely-delivered session, all parents will receive quarterly booster messages via text or email.

Study Assessments

Dyads will be asked to complete online assessments after consent is given (baseline) and within the 4 days prior to Session 3. A first post-intervention assessment will occur 4 weeks after the last intervention session is held. A second post-intervention assessment will occur 4 weeks later. The long-term follow-up assessment will take place 1-year post-baseline. Each assessment is expected to take 15-30 minutes. Parents will also receive a brief assessment via text or email (depending on parent preference) at monthly intervals between the second post-assessment and the 1-year post-baseline assessment, and in the summer months immediately following the 1-year post-baseline assessment. All assessments will be completed electronically.

Conditions: Melanoma, Child
Being tested: FLARE Intervention
Keywords: Education, Prevention and Control, Behavioral Research
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLARE InterventionBehavioural
[See arm/group descriptions]

Study groups in NCT04201223
Study group	Role	What they receive
FLARE Intervention	Experimental	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. Receives: Behavioral: FLARE Intervention
Standard Education	No intervention	Participants will be randomized to receive information on child sun protection that is publicly available.

What is being measured

The primary outcome is the main question the study is designed to answer.

Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
We will measure the mean/standard deviation of child sunburn occurrence at all timepoints.
"In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.
Measured: Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment

Secondary outcomes (7)

Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
Mean/Standard deviation of skin tone at all timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone.
Measured: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
Mean/standard deviation of sunscreen application occurrence at all timepoints.
"These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you use sunscreen with an SPF of 30+?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Measured: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
Mean/standard deviation of sunscreen re-application occurrence at all timepoints.
"These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Measured: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
Mean/standard deviation of long sleeved shirt occurrence at all timepoints.
"These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Measured: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
Mean/standard deviation of long pants/skirt occurrence at all timepoints.
"These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Measured: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
Mean/standard deviation of shade occurrence at all timepoints.
"These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Measured: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
Mean/standard deviation of avoidance of peak hours at all timepoints.
"These next questions ask about what you have done in the past (time frame) if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Measured: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 202028 Jan 2025

First posted17 Dec 2019
Study start7 Apr 2020
Primary completion28 Jan 2025
Study completion28 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 752 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04201223
Sponsor's protocol ID: IRB_00114901
Other IDs: 133811-RSG-19-121-01-CPPB
Acronym: FLARE
Status last verified: Jun 2026
First submitted: 26 Nov 2019
Last updated: 10 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wu YP, Stump TK, Deboeck PR, Woodside LA, Moyano J, Hay JL, Aspinwall LG, Boucher KM, Grossman D, Mooney K, Leachman SA, Smith KR, Hancock SE, Wankier AP, Tercyak KP. Melanoma Prevention Among Children of Melanoma Survivors: A Randomized Clinical Trial. JAMA Dermatol. 2026 Oct 7:10.1001/jamadermatol.2026.3877. doi: 10.1001/jamadermatol.2026.3877. Online ahead of print.
PubMed 42842243
Wu YP, Stump TK, Deboeck PR, Hay JL, Aspinwall LG, Boucher KM, Grossman D, Mooney K, Leachman SA, Smith KR, Brady HL, Hancock SE, Wankier AP, Tercyak KP. Sun protection, sunburn, tanning, and family factors among melanoma survivors and their minor children. J Health Psychol. 2026 May;31(6):2241-2256. doi: 10.1177/13591053251378226. Epub 2025 Oct 9.
PubMed 41067748

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The FLARE Skin Cancer Prevention Intervention for Children of Melanoma Survivors
ClinicalTrials.gov ID: NCT04201223
Acronym / sponsor ID: FLARE / IRB_00114901
Conditions: Melanoma, Child
Keywords: Education, Prevention and Control, Behavioral Research
Study type: Interventional
Recruitment status: Completed
Enrolment: 752 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: American Cancer Society, Inc.
Study start: 7 Apr 2020 (actual)
Primary completion: 28 Jan 2025 (actual)
Study completion: 28 Jan 2025 (actual)
First posted: 17 Dec 2019 (actual)
Results: Posted 18 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Enrollment

Intervention Sessions

Study Assessments

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FLARE Intervention	Experimental	Behavioral: FLARE InterventionParticipants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
Standard Education	No intervention	–Participants will be randomized to receive information on child sun protection that is publicly available.

Who may qualify

Ages: 8 to 110 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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.
Are between the ages of 8-17 years AND
Had at least 1 sunburn in the last 12 months AND

Key exclusion criteria (6 listed)

Adults and children will be excluded from participation if they meet any of the following:
Do not speak English
Are unable to participate due to developmental delay
Received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p16.
Enrolled in a study led by an investigator at another institution, which also focuses on improving skin cancer prevention behaviors and utilizes the Utah Cancer Registry for study recruitment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLARE Intervention[See arm/group descriptions]	Behavioural	FLARE Intervention

Primary outcome

Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
Time frame: Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
We will measure the mean/standard deviation of child sunburn occurrence at all timepoints. "In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.

7 secondary outcomes

Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
Time frame: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
Time frame: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
Time frame: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
Time frame: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
Time frame: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
Time frame: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
Time frame: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment

Results and safety

Results posted to the registry on 18 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLARE Intervention Parent	180	169
FLARE Intervention Child	180	169
Standard Education Parent	184	180
Standard Education Child	184	180

Primary outcome: Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey

Time frame: Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment. Mean (Standard Deviation). Unit: score on a scale

Measure	FLARE Intervention n = 180	Standard Education n = 184
Baseline (Wk 0)	0.59 (.851)	0.63 (0.932)
Mid-Intervention Assessment	0.42 (0.611)	0.56 (0.837)
Post-Assessment 1 (Wk 8-11)	0.29 (0.522)	0.51 (0.849)
Post-Assessment 2 (Wk 12-15)	0.26 (0.486)	0.51 (0.644)
1-Year Follow-Up (Wk 52)	0.27 (0.573)	0.53 (0.737)

Population analysed: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 2 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event and Serious Adverse Event data were not collected for this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLARE Intervention	0 of 0	0 of 0	0
Standard Education	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42842243Wu YP, Stump TK, Deboeck PR, Woodside LA, Moyano J, Hay JL, Aspinwall LG, Boucher KM, Grossman D, Mooney K, Leachman SA, Smith KR, Hancock SE, Wankier AP, Tercyak KP. Melanoma Prevention Among Children of Melanoma Survivors: A Randomized Clinical Trial. JAMA Dermatol. 2026 Oct 7:10.1001/jamadermatol.2026.3877. doi: 10.1001/jamadermatol.2026.3877. Online ahead of print.
Derived from this study: PubMed 41067748Wu YP, Stump TK, Deboeck PR, Hay JL, Aspinwall LG, Boucher KM, Grossman D, Mooney K, Leachman SA, Smith KR, Brady HL, Hancock SE, Wankier AP, Tercyak KP. Sun protection, sunburn, tanning, and family factors among melanoma survivors and their minor children. J Health Psychol. 2026 May;31(6):2241-2256. doi: 10.1177/13591053251378226. Epub 2025 Oct 9.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yelena Wu, PhD principal investigator

University of Utah

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FLARE Intervention in people with Melanoma and Child, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey (time frame: Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04201223, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.