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Completed

NCT Number: NCT04201223

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

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.

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Key information

Conditions

Melanoma Child Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

8 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

FLARE Intervention

Behavioral

[See arm/group descriptions]

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Mean/Standard deviation of skin tone at all timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone.

  2. 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

    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

  3. 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

    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

  4. 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

    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

  5. 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

    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

  6. 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

    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

  7. 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

    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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

The FLARE Skin Cancer Prevention Intervention for Children of Melanoma Survivors

Acronym: FLARE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2019
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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