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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
42
Huntsman Cancer Institute
Salt Lake City, Utah, United States
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.
Time frame: Week 9 (post-intervention)
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
Time frame: 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
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
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
Time frame: 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
Time frame: Weeks 1 (baseline), 3,5,7,9,13
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Sunburn Occurrence Assessed Via Questionnaire
Number of participants who received a sunburn during each time frame.
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)
Time frame: 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
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).
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Week 9