The FLARE Skin Cancer Prevention Intervention for Children of Melanoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 752
- 试验地点
- 1
- 主要终点
- Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
研究概览
简要总结
The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.
详细描述
Enrollment
After parent-child dyads complete screening and informed consent/assent procedures, participants will be invited to complete an online baseline assessment. Following the baseline assessment, dyads will be randomized to receive either the FLARE intervention or standard education. After randomization, each dyad will receive a unique log-in to a secure study website that will be used to review didactic materials prior to each intervention session.
Intervention Sessions
Dyads will meet with an interventionist via remotely-delivered live session for their three intervention sessions. Intervention sessions will be scheduled every two weeks. After completion of the last remotely-delivered session, all parents will receive quarterly booster messages via text or email.
Study Assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Adults are eligible for this trial if they:
- •Are at least 18 years old AND
- •Have been diagnosed with melanoma at any time in their life AND
- •Have at least one biological child between the ages of 8-17 years who is able to participate in the trial with them.
- •Children are eligible to participate with their parent if they:
- •Are between the ages of 8-17 years AND
- •Had at least 1 sunburn in the last 12 months AND
- •Have at least one biological parent with a history of melanoma who can participate in the trial with them.
排除标准
- •Adults and children will be excluded from participation if they meet any of the following:
- •Do not speak English
- •Are unable to participate due to developmental delay
- •Received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p
- •Enrolled in a study led by an investigator at another institution, which also focuses on improving skin cancer prevention behaviors and utilizes the Utah Cancer Registry for study recruitment.
- •Have only a history of ocular melanoma
研究组 & 干预措施
FLARE Intervention
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
干预措施: FLARE Intervention (Behavioral)
Standard Education
Participants will be randomized to receive information on child sun protection that is publicly available.
结局指标
主要结局
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
时间窗: Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
We will measure the mean/standard deviation of child sunburn occurrence at all timepoints. "In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.
次要结局
- Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette(Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment)
- Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey(Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment)
- Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey(Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment)
- Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey(Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment)
- Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey(Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment)
- Parent Report on Child Shade Use Assessed Via Sun Habits Survey(Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment)
- Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey(Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment)
研究者
Yelena Wu
Assistant Professor, Investigator
University of Utah