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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	8 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04201223
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Utah
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yelena Wu, PhD
Principal Investigator Affiliation	University of Utah
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Child

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

No Intervention: Standard Education

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

Interventions

Behavioral: - FLARE Intervention

[See arm/group descriptions]

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

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