Family Lifestyle Actions and Risk Education Study

Study Overview
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Brief Summary
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The overall purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a family-focused behavioral intervention (FLARE, which stands for Family Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive behaviors among children at elevated risk for the disease.

Detailed Description
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Test the feasibility and acceptability of FLARE, a family-focused behavioral intervention that is designed to improve and maintain adherence to photoprotection (e.g., use of sunscreen) and screening (e.g., implementation of self skin exams). We expect that the feasibility of the intervention will be supported by at least 75% of participants attending at least 3 intervention sessions. We also expect that the acceptability of the intervention (e.g., overall satisfaction, ease of participation, perceived utility of intervention) will be supported by mean ratings that indicate adequate levels of acceptability across participants (e.g., mean rating of satisfied or very satisfied for overall satisfaction). Pilot test the efficacy of the FLARE intervention with children at elevated risk for melanoma and their primary caregiver. We will also explore the potential impact of the FLARE intervention on melanoma preventive behaviors among siblings of the child who receives the intervention, as well as the child's other parent/caregiver (if another parent/caregiver is available).

Official Title
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FLARE: Family Lifestyle Actions and Risk Education Study for Children With a Familial Risk for Melanoma

Conditions
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Melanoma, Child

Intervention / Treatment
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* Behavioral: FLARE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children Are 8-17 years old AND Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma AND/OR Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing Adults Are at least 18 years old AND Are the primary caregiver for the child participating in the study (defined as the individual who is responsible for daily implementation of health-related tasks for the child) AND Have at least one child under age 18 who is living in the same household AND Have a personal history of melanoma and/or family history of melanoma) AND/OR Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing Exclusion Criteria: Individuals who do not speak, read/write English will be excluded because FLARE involves regular interaction between study staff and research participants in English and completion of study questionnaires and interviews in English

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLARE intervention<br>All FLARE participants enrolled will receive the intervention | Behavioral: FLARE<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist | Session attendance will be recorded by the interventionist at each scheduled session. The percent of participants who are retained throughout the 3 session intervention will be calculated. | Week 9 (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photoprotective Behaviors Assessed With the Sun Habits Survey | These next questions ask about what you have done in the past month if you were outdoors in the sun for 15 minutes or more. How often did you... Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome | Weeks 1 (baseline), 3,5,7,9,13 | 
| Photoprotective Behaviors Assessed With the PALE Questionnaire | Protection-Adjusted Length of Exposure Index (PALE) Assesses photoprotective behavior during reported activities to yield daily minutes of unprotected sun exposure during each time frame | Weeks 1 (baseline), 3,5,7,9,13 | 
| Skin Self-exam Occurrence Assessed Via Questionnaire | Number of participants who received a skin self-exam during each time frame | Weeks 1 (baseline), 3,5,7,9,13 | 
| Skin Self-exam Occurrence Assessed Via Diary | Number of participants who received a skin self-exam during each time frame interval | Weeks 1 (baseline), 3,5,7,9,13 | 
| Sunburn Occurrence Assessed Via Diary | Number of participants who got a sunburn during each time frame interval | Weeks 1 (baseline), 3,5,7,9,13 | 
| Sunburn Occurrence Assessed Via Questionnaire | Number of participants who received a sunburn during each time frame. | Weeks 1 (baseline), 3,5,7,9,13 | 
| Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device | Change of weekly average UV intake from Week 1 (baseline) to Week 9 (post-intervention) and from Week 9 to Week 13 (1-month follow up) | Weeks 1 (baseline),9,13 | 
| Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire | Protection-Adjusted Length of Exposure Index (PALE) Assesses UVR exposure during reported activities to yield daily minutes of unprotected sun exposure during each time frame | Weeks 1 (baseline), 3,5,7,9,13 | 
| Degree of Tan on Skin Assessed Via Reflectance Spectroscopy | Mean degree of tan on skin assessed via reflectance spectroscopy of 4 different body parts (exposed wrist, outer arm, chin, and face) at each time frame. Measurements were taken using a spectrophotometer to quantify skin color. Melanin index values were recorded, with a higher value representing more melanin in the skin (i.e., darker skin). | Weeks 1 (baseline),9,13 | 
| Photoprotection Behavior Changes Assessed Via Questionnaire | Mean difference for each photoprotection behavior from Week 1 (pre-intervention) to Week 9 (post-intervention) and from Week 9 to Week 13 (1 month follow-up). These next questions ask about what you have done in the past month if you were outdoors in the sun for 15 minutes or more. How often did you... Minimum value = 1; Maximum value = 5; A higher mean difference indicates a better outcome | Weeks 1,9,13 | 
| Skin Self-exam Behavior Changes | Mean difference for frequency of skin self-exam and thoroughness of skin self-exam (measured by number of body parts examined) from Week 1 (pre-intervention) to Week 9 (post-intervention) and from Week 9 to Week 13 (1 month follow-up). (SSE = skin self-exam) Change in frequency of SSE: In the past month, how often did you check your skin for any new or changed moles or growths? 1 = SSE less than once a month, 2 = SSE once a month, 3 = SSE more than once a month; higher mean difference indicates a better outcome. Change in thoroughness of SSE: In the past month, which of the body parts listed below were checked for any new or changed moles or growths Minimum value = 0 (checked 0 body parts during SSE); Maximum value = 15 (checked 15 body parts during SSE); higher mean difference indicates a better outcome | Weeks 1,9,13 | 
| Acceptability of Intervention Assessed Via Questionnaire | In these next 15 questions, we want to learn more about your thoughts about what you learned through the FLARE sessions you've had with us in-person and via WebEx or phone. Please indicate how much you agree with each statement. 15 total constructs summed, each was on the same 5 point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Minimum value = 1; Maximum Value = 75; higher score means a better outcome (better acceptability) | Week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Prevention and Control, Behavioral Research