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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

762 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-07

Study Completion Date

2025-01-31

Brief Summary

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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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Detailed Description

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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

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Melanoma Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FLARE Intervention

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.

Group Type EXPERIMENTAL

FLARE Intervention

Intervention Type BEHAVIORAL

\[See arm/group descriptions\]

Standard Education

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FLARE Intervention

\[See arm/group descriptions\]

Intervention Type BEHAVIORAL

Eligibility Criteria

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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:

* 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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes