Clinical trial NCT04201223: Family Lifestyles, Actions, and Risk Education Intervention: Version 2
Official title: The FLARE Skin Cancer Prevention Intervention for Children of Melanoma Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Melanoma
Child
Keywords: Education
Prevention and Control
Behavioral Research
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2019-12-17
Enrollment: 762
Sex: ALL
Minimum age (years): 8
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in Child Sunburn Occurrence Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), Monthly Assessment (Wk 18-41), 1-Year Follow-Up (Wk 52), Follow-Up 2 (Wk 56), Follow-Up 3 (Wk 60), Follow-Up 4 (Wk 64)
Secondary outcomes:
measure: Skin Tone Assessed Via 11-Point Skin Color Palette
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
measure: Sunscreen Application Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
measure: Sunscreen Re-Application Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
measure: Long Sleeved Shirt Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
measure: Long Pants/Skirt Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
measure: Shade Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
measure: Peak Hours Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
measure: Time Spent in the Sun to get Tan Behavior Changes Assessed Via Sun Habits Survey
timeFrame: Baseline Assessment (Wk 0), Session 3 (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Yelena Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: