Family Lifestyles, Actions, and Risk Education Intervention: Version 2 (NCT04201223) | Clinical Trial Compass
CompletedNot Applicable
Family Lifestyles, Actions, and Risk Education Intervention: Version 2
United States752 participantsStarted 2020-04-07
Plain-language 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.
Who can participate
Age range
8 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
Timeframe: 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