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

NCT04201223 | Completed Results DMC

• 2 other identifiers: IRB_00114901133811-RSG-19-121-01-CPPB
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma; Child

Keywords

Education; Prevention and Control; Behavioral Research

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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

Study Arms (2)

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.

Behavioral: FLARE Intervention

Standard Education

NO INTERVENTION

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

Interventions

FLARE Intervention BEHAVIORAL

\[See arm/group descriptions\]

FLARE Intervention

Eligibility Criteria

• Age: 8 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 41067748 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Yelena Wu
• Organization: Huntsman Cancer Institute at University of Utah

Yelena.Wu@hci.utah.edu

801-213-5653

Study Officials

• Yelena Wu, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Investigator

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 17, 2019
• Study Start: April 7, 2020
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: July 10, 2026
• Results First Posted: June 18, 2026

Record last verified: 2026-06

Locations

US (1)