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

Melanoma Clinical Trial

— FLARE  

Official title:

The FLARE Skin Cancer Prevention Intervention for Children of Melanoma Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04201223
• Other study ID #: IRB_00114901
• Secondary ID: 133811-RSG-19-12
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 7, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 762
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Melanoma

Intervention

Behavioral:
• FLARE Intervention
[See arm/group descriptions]

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Child Sunburn Occurrence Assessed Via Sun Habits Survey	We will examine whether sunburn occurrence decreased over time from pre- to post-intervention (Baseline through Post-Assessment 2), specifically whether the odds of sunburn occurrence are lower for FLARE compared to standard education. Additional analyses will compare sunburn occurrence between groups immediately post-intervention at Post-Assessment 1, and over the course of one year post-baseline. In all analyses, we will control for differences in sun exposure over time.; "In the past (time period), how many times did you have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.	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	Skin Tone Assessed Via 11-Point Skin Color Palette	Mean/Standard deviation of the difference in skin tone between timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone.	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)
Secondary	Sunscreen Application Behavior Changes Assessed Via Sun Habits Survey	Mean/standard deviation of the difference in sunscreen application occurrence between timepoints.; "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you use a screen with an SPF of 30+?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	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)
Secondary	Sunscreen Re-Application Behavior Changes Assessed Via Sun Habits Survey	Mean/standard deviation of the difference in sunscreen re-application occurrence between timepoints.; "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	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)
Secondary	Long Sleeved Shirt Behavior Changes Assessed Via Sun Habits Survey	Mean/standard deviation of the difference in long sleeved shirt occurrence between timepoints.; "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	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)
Secondary	Long Pants/Skirt Behavior Changes Assessed Via Sun Habits Survey	Mean/standard deviation of the difference in long pants/skirt occurrence between timepoints.; "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	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)
Secondary	Shade Behavior Changes Assessed Via Sun Habits Survey	Mean/standard deviation of the difference in shade occurrence between timepoints.; "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	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)
Secondary	Peak Hours Behavior Changes Assessed Via Sun Habits Survey	Mean/standard deviation of the difference in avoidance of peak hours between timepoints.; "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	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)
Secondary	Time Spent in the Sun to get Tan Behavior Changes Assessed Via Sun Habits Survey	Mean/standard deviation of the difference in time spent in the sun to get tan between timepoints.; "These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you spend time in the sun in order to get a tan?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	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)