Family Lifestyles, Actions, and Risk Education Intervention: Version 2 (FLARE)
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Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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 design
Primary purpose
Allocation
Interventional model
Masking
762 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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