家庭生活方式、行为和风险教育干预：第 2 版 (FLARE)
针对黑色素瘤幸存者儿童的 FLARE 皮肤癌预防干预
研究概览
详细说明
注册
在亲子二人完成筛选和知情同意/同意程序后，将邀请参与者完成在线基线评估。 在基线评估之后，将随机分配 dyads 接受 FLARE 干预或标准教育。 随机化后，每个二人组都会收到一个安全研究网站的唯一登录信息，该网站将用于在每次干预会议之前审查教学材料。
干预会议
Dyads 将在他们的三个干预会议中通过远程直播会议与干预人员会面。 干预会议将每两周安排一次。 在最后一次远程授课结束后，所有家长都将通过短信或电子邮件收到季度强化信息。
学习评估
Dyads 将被要求在同意后（基线）和第 3 节之前的 4 天内完成在线评估。第一次干预后评估将在最后一次干预会议举行后 4 周进行。 第二次干预后评估将在 4 周后进行。 长期后续评估将在基线后 1 年进行。 每次评估预计需要 15-30 分钟。 在第二次后评估和 1 年基线后评估之间的每月间隔，以及在 1 年后基线评估之后的夏季，家长还将通过短信或电子邮件（取决于家长的偏好）收到简短的评估评估。 所有评估都将以电子方式完成。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Utah
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
如果成年人符合以下条件，则他们有资格参加此试验：
- 至少 18 岁并且
- 在他们生命中的任何时候被诊断出患有黑色素瘤并且
- 至少有一名 8-17 岁的亲生子女能够与他们一起参加试验。
符合以下条件的儿童有资格与父母一起参加：
- 年龄在 8-17 岁之间并且
- 在过去 12 个月内至少有 1 次晒伤并且
- 至少有一位亲生父母有黑色素瘤病史，可以和他们一起参加试验。
排除标准：
如果有以下情况，成人和儿童将被排除在参与之外：
- 不会说英语或
- 由于发育迟缓而无法参加或
- 接受了 CDKN2A/p16 突变检测，包括那些参与先前研究的人，他们收到了有关 CDKN2A/p16 的信息。
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：耀斑干预
参与者将被随机接受一项干预措施，该干预措施与黑色素瘤幸存者及其子女作为一个家庭单位一起工作，以改善黑色素瘤的预防行为。
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[见手臂/组描述]
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无干预：标准教育
参与者将被随机接收公开的儿童防晒信息。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
大体时间：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
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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. |
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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
大体时间：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
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Mean/Standard deviation of skin tone at all timepoints.
Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone.
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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
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Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
大体时间：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
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Mean/standard deviation of sunscreen application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you use sunscreen with an SPF of 30+?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
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
|
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Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
大体时间：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
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Mean/standard deviation of sunscreen re-application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
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
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Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
大体时间：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
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Mean/standard deviation of long sleeved shirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
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
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Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
大体时间：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
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Mean/standard deviation of long pants/skirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
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
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Parent Report on Child Shade Use Assessed Via Sun Habits Survey
大体时间：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
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Mean/standard deviation of shade occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
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
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Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
大体时间：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
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Mean/standard deviation of avoidance of peak hours at all timepoints. "These next questions ask about what you have done in the past (time frame) if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome |
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
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合作者和调查者
调查人员
- 首席研究员：Yelena Wu, PhD、University of Utah
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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