Clinical trial NCT02846714: Family Lifestyle Actions and Risk Education Study
Official title: FLARE: Family Lifestyle Actions and Risk Education Study for Children With a Familial Risk for Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Child
Keywords: Education
Prevention and Control
Behavioral Research
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-27
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist
timeFrame: Week 9 (post-intervention)
Secondary outcomes:
measure: Photoprotective Behaviors Assessed With the Sun Habits Survey
timeFrame: Weeks 1 (baseline), 3,5,7,9,13
measure: Photoprotective Behaviors Assessed With the PALE Questionnaire
timeFrame: Weeks 1 (baseline), 3,5,7,9,13
measure: Skin Self-exam Occurrence Assessed Via Questionnaire
timeFrame: Weeks 1 (baseline), 3,5,7,9,13
measure: Skin Self-exam Occurrence Assessed Via Diary
timeFrame: Weeks 1 (baseline), 3,5,7,9,13
measure: Sunburn Occurrence Assessed Via Diary
timeFrame: Weeks 1 (baseline), 3,5,7,9,13
measure: Sunburn Occurrence Assessed Via Questionnaire
timeFrame: Weeks 1 (baseline), 3,5,7,9,13
measure: Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device
timeFrame: Weeks 1 (baseline),9,13
measure: Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire
timeFrame: Weeks 1 (baseline), 3,5,7,9,13
measure: Degree of Tan on Skin Assessed Via Reflectance Spectroscopy
timeFrame: Weeks 1 (baseline),9,13
measure: Photoprotection Behavior Changes Assessed Via Questionnaire
timeFrame: Weeks 1,9,13
measure: Skin Self-exam Behavior Changes
timeFrame: Weeks 1,9,13
measure: Acceptability of Intervention Assessed Via Questionnaire
timeFrame: Week 9
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:
citation: Glanz K, Yaroch AL, Dancel M, Saraiya M, Crane LA, Buller DB, Manne S, O'Riordan DL, Heckman CJ, Hay J, Robinson JK. Measures of sun exposure and sun protection practices for behavioral and epidemiologic research. Arch Dermatol. 2008 Feb;144(2):217-22. doi: 10.1001/archdermatol.2007.46.
citation: Weinstock MA, Risica PM, Martin RA, Rakowski W, Smith KJ, Berwick M, Goldstein MG, Upegui D, Lasater T. Reliability of assessment and circumstances of performance of thorough skin self-examination for the early detection of melanoma in the Check-It-Out Project. Prev Med. 2004 Jun;38(6):761-5. doi: 10.1016/j.ypmed.2004.01.020.
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citation: Gage H, Grainger L, Ting S, Williams P, Chorley C, Carey G, Borg N, Bryan K, Castleton B, Trend P, Kaye J, Jordan J, Wade D. Specialist rehabilitation for people with Parkinson's disease in the community: a randomised controlled trial. Southampton (UK): NIHR Journals Library; 2014 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK263782/
citation: Stump, T. K., Aspinwall, L. G., Taber, J. M., Edwards, R., & Leachman, S. A. Validation of the Protection-Adjusted Length of Exposure (PALE) Index - A New Self-Report Measure of UVR Exposure (2014, April). Paper presented at the annual meeting of the Society of Behavioral Medicine, Philadelphia, PA.
citation: Wu YP, Boucher K, Hu N, Hay J, Kohlmann W, Aspinwall LG, Bowen DJ, Parsons BG, Nagelhout ES, Grossman D, Mooney K, Leachman SA, Tercyak KP. A pilot study of a telehealth family-focused melanoma preventive intervention for children with a family history of melanoma. Psychooncology. 2020 Jan;29(1):148-155. doi: 10.1002/pon.5232. Epub 2019 Nov 10.