FLARE: Family Lifestyle Actions and Risk Education Study for Children With a Familial Risk for Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 110 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
FLARE intervention
All FLARE participants enrolled will receive the intervention
干预措施: FLARE (Behavioral)
结局指标
主要结局
Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist
时间窗: Week 9 (post-intervention)
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.
次要结局
- Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device(Weeks 1 (baseline),9,13)
- Photoprotective Behaviors Assessed With the Sun Habits Survey(Weeks 1 (baseline), 3,5,7,9,13)
- Photoprotective Behaviors Assessed With the PALE Questionnaire(Weeks 1 (baseline), 3,5,7,9,13)
- Skin Self-exam Occurrence Assessed Via Questionnaire(Weeks 1 (baseline), 3,5,7,9,13)
- Sunburn Occurrence Assessed Via Diary(Weeks 1 (baseline), 3,5,7,9,13)
- Sunburn Occurrence Assessed Via Questionnaire(Weeks 1 (baseline), 3,5,7,9,13)
- Acceptability of Intervention Assessed Via Questionnaire(Week 9)
- Skin Self-exam Occurrence Assessed Via Diary(Weeks 1 (baseline), 3,5,7,9,13)
- Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire(Weeks 1 (baseline), 3,5,7,9,13)
- Degree of Tan on Skin Assessed Via Reflectance Spectroscopy(Weeks 1 (baseline),9,13)
- Photoprotection Behavior Changes Assessed Via Questionnaire(Weeks 1,9,13)
- Skin Self-exam Behavior Changes(Weeks 1,9,13)
研究者
Yelena Wu
Assistant Professor, Investigator
University of Utah