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

NCT04201223 | Unknown DMC

• 2 other identifiers: IRB_00114901133811-RSG-19-121-01-CPPB
• Study Type: interventional
• Target: 762
• 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)

• Change in Child Sunburn Occurrence Assessed Via Sun Habits Survey

  We will examine whether sunburn occurrence decreased over time from pre- to post-intervention (Baseline through Post-Assessment 2), specifically whether the odds of sunburn occurrence are lower for FLARE compared to standard education. Additional analyses will compare sunburn occurrence between groups immediately post-intervention at Post-Assessment 1, and over the course of one year post-baseline. In all analyses, we will control for differences in sun exposure over time. "In the past (time period), how many times did you 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), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), Monthly Assessment (Wk 18-41), 1-Year Follow-Up (Wk 52), Follow-Up 2 (Wk 56), Follow-Up 3 (Wk 60), Follow-Up 4 (Wk 64)

Secondary Outcomes (8)

• Skin Tone Assessed Via 11-Point Skin Color Palette

  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)

• Sunscreen Application Behavior Changes Assessed Via Sun Habits Survey

  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)

• Sunscreen Re-Application Behavior Changes Assessed Via Sun Habits Survey

  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)

• Long Sleeved Shirt Behavior Changes Assessed Via Sun Habits Survey

  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)

• Long Pants/Skirt Behavior Changes Assessed Via Sun Habits Survey

  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)

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:
• Do not speak English OR
• Are unable to participate due to developmental delay OR
• Received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p16.

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. 2025 Oct 9:13591053251378226. doi: 10.1177/13591053251378226. Online ahead of print.

  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

Study Officials

• Yelena Wu, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

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 31, 2025
• Study Completion: January 31, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)