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

N/ACompletedNCT04201223

University of Utah752 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Conditions

Melanoma Child

Interventions

FLARE InterventionBEHAVIORAL

\[See arm/group descriptions\]

Eligibility

Sex: ALLMin age: 8 YearsMax age: 110 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

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

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

Data from ClinicalTrials.gov

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