Clinical trial · Interventional
Family Lifestyle Actions and Risk Education Study
FLARE: Family Lifestyle Actions and Risk Education Study for Children With a Familial Risk for Melanoma
NCT02846714CI-TRIAL-00038516FLAREcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Child | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLARE | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FLARE intervention
- description
- All FLARE participants enrolled will receive the intervention
- interventionNames
- Behavioral: FLARE
Primary outcomes (1)
- measure
- Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist
- timeFrame
- Week 9 (post-intervention)
- description
- 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.
Secondary outcomes (12)
- measure
- Photoprotective Behaviors Assessed With the Sun Habits Survey
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDGlanz 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. PMID 18283179
- BACKGROUNDWeinstock 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. PMID 15193896
- BACKGROUNDGwadry-Sridhar F, Guyatt GH, Arnold JM, Massel D, Brown J, Nadeau L, Lawrence S. Instruments to measure acceptability of information and acquisition of knowledge in patients with heart failure. Eur J Heart Fail. 2003 Dec;5(6):783-91. doi: 10.1016/s1388-9842(03)00158-2. PMID 14675857
- BACKGROUNDKothe EJ, Mullan BA. Acceptability of a theory of planned behaviour email-based nutrition intervention. Health Promot Int. 2014 Mar;29(1):81-90. doi: 10.1093/heapro/das043. Epub 2012 Aug 31. PMID 22942273
- BACKGROUNDGage 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/ PMID 25642574
- BACKGROUNDStump, 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.
- DERIVEDWu 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.