减少青少年和年轻成人肿瘤学中的情绪困扰、增强功能和改善网络参与 (REDEFINEAYAO)
2021年7月30日 更新者：David Victorson、Northwestern University
重新定义 AYAO：减少青少年和年轻成人肿瘤学中的情绪困扰、增强功能和改善网络参与
我们建议检查基于正念的压力减轻 (MBSR) 对健康相关生活质量、疾病症状和压力的生物相关性结果的影响，样本为年轻的癌症患者。
拟议的工作将作为针对这一传统上服务不足的人群启动临床减压研究计划的重要基础，并有可能导致发现特定的、可修改的社会心理、行为和生物学机制，从中解决压力问题与这个群体的健康差异。
研究概览
详细说明
主要目标检查 MBSR 与 YAC 的可行性和可接受性。 我们假设 MBSR 对该人群是可行和可接受的，这将通过检查反应率和研究损耗变量来评估。
次要目标
- 评估 MBSR 对 YAC 健康相关生活质量和疾病症状结果的影响。
- 探索 MBSR 干预后不同形式的 eHealth 维护支持的影响（教师提供、同伴提供、无消息），以帮助随着时间的推移维持干预效果。
- 比较干预组和对照组在 32 周内压力生物学指标（血压、脉搏、唾液皮质醇、CRP 和 IL-6 生物标志物）的变化。
研究类型
介入性
注册 (实际的)
151
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago、Illinois、美国、60611
- Northwestern University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 39年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 必须在 18-39 岁之间诊断出任何癌症
- 必须签署并注明日期的知情同意书，其中包括同意研究程序
- 目前必须在 18-39 岁之间
- 必须能够读、写、说和理解英语
- 必须能够进行日常生活的基本活动
- 必须在认知上完好无损并且没有严重的精神疾病
- 必须能够在平板设备上使用触摸屏键盘
- 必须愿意接受 MBSR 课程或候补名单控制条件
- 必须愿意承诺电子健康干预维护条件
- 必须愿意完成所有评估
排除标准：
- 卧床不起或身体虚弱以至于无法参与研究或会造成过度困难
- 由转诊医生确定的被诊断为严重精神疾病或因慢性精神病原因住院的病史
- 定期使用基于正念的减压或类似的身心疗法（例如瑜伽、冥想），定义为过去 2 周内每周 ≥ 3 次
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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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有源比较器：A组
A 组参加第一个可用的 MBSR 课程。
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MBSR 主要基于正念冥想和瑜伽的指导，是一项以团体为基础的为期 8 周的课程，在 Jon Kabat-Zinn 的指导下在马萨诸塞大学减压诊所开发。
MBSR 由一个结构化的、按发展顺序排列的课程组成，该课程使用小组形式以体验方式指导参与者练习正念冥想和正念哈达瑜伽。
每个课程都包括不同形式的冥想练习，例如培养对思想、感觉和身体感觉的认识，以及学习在压力大的情绪和/或身体生活情况下融入这种意识。
其他名称：
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有源比较器：B组
B 组在参加 MBSR 课程之前等待 16 周。
|
MBSR 主要基于正念冥想和瑜伽的指导，是一项以团体为基础的为期 8 周的课程，在 Jon Kabat-Zinn 的指导下在马萨诸塞大学减压诊所开发。
MBSR 由一个结构化的、按发展顺序排列的课程组成，该课程使用小组形式以体验方式指导参与者练习正念冥想和正念哈达瑜伽。
每个课程都包括不同形式的冥想练习，例如培养对思想、感觉和身体感觉的认识，以及学习在压力大的情绪和/或身体生活情况下融入这种意识。
其他名称：
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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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通过检查响应率和研究损耗变量评估可行性
大体时间：第 33 周
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通过检查响应率和研究损耗变量评估可行性
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第 33 周
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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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通过在线问卷调查对健康相关生活质量的影响
大体时间：基线和研究第 8、16、24 和 32 周
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通过在线问卷调查对健康相关生活质量的影响
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基线和研究第 8、16、24 和 32 周
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通过短信响应访问电子健康维护支持的影响
大体时间：每周一次，在 MBSR 课程后连续 8 周
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通过短信响应访问电子健康维护支持的影响
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每周一次，在 MBSR 课程后连续 8 周
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比较通过生物标志物获得的应激生物学测量的组间变化
大体时间：第 16 周和第 32 周的基线和研究
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比较通过获得的压力生物学测量的组间变化
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第 16 周和第 32 周的基线和研究
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：David E Victorson, PhD、Northwestern University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年6月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2015年7月9日
首先提交符合 QC 标准的
2015年7月9日
首次发布 (估计)
2015年7月13日
研究记录更新
最后更新发布 (实际的)
2021年8月5日
上次提交的符合 QC 标准的更新
2021年7月30日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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