增加女性的结直肠癌和乳腺癌筛查 (COBRA)
2017年9月8日 更新者：Victoria L. Champion、Indiana University
本研究比较了四种干预措施在 50 至 75 岁女性中促进结直肠癌 (CRC) 和乳腺癌 (BC) 筛查的功效（依从性和分期）。 他们是：
- 日常护理；
- TIWeb（量身定制的干预网站）
- CSC（癌症筛查电话）和
- TIWeb + 一个 CSC。 这项研究还比较了 4 种干预措施的成本效益，以促进 50 至 75 岁女性的 CRC 和 BC 筛查。
研究概览
详细说明
本研究探讨了提高结直肠癌和乳腺癌筛查试验依从性的创新方法——这两种癌症对美国女性癌症死亡率影响最大。通过增加对结直肠癌推荐筛查的参与度，可以显着降低女性的癌症负担所有符合条件的女性的癌症 (CRC) 和乳腺癌 (BC)。
本研究测试了使用行为改变策略同时增加 CRC 和 BC 筛查的干预措施，并评估了干预措施的有效性和成本效益。
两组女性，A 组（遵守 BC 筛查指南，但不遵守 CRC 筛查指南）和 B 组（不遵守 BC 和 CRC 指南）被随机分配到 1. 常规护理，2. TIWeb，3. CSC 和4.TIWeb+CSC。
研究类型
介入性
注册 (实际的)
1196
阶段
- 不适用
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
50年 至 75年 (成人、OLDER_ADULT)
接受健康志愿者
是的
有资格学习的性别
女性
描述
纳入标准：
- 任何参与医生的患者
- 在过去 12 个月内没有进行过粪便潜血试验 (fobt)
- 在过去 15 个月内没有进行过粪便免疫化学测试（适合）
- 5 年多以前没有进行过乙状结肠镜检查
- 10 多年前没有做过结肠镜检查
- 有高速互联网接入
排除标准
- 结直肠癌的个人病史
- 个人乳腺癌史
- 结直肠息肉的个人史
- 炎症性肠病的个人病史
- 有任何会禁止乳房 X 光检查或 CRC 筛查的健康状况
- 已经进行过 CRC 筛查
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：预防
- 分配：随机化
- 介入模型：阶乘
- 屏蔽：没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
PLACEBO_COMPARATOR：常规护理 (UC)
常规护理组接受的常规护理因实践环境而异。
|
干预：常规护理组接受的常规护理因实践环境而异。
其他名称：
|
|
ACTIVE_COMPARATOR：TI网
TIWeb（量身定制的网络干预）计划是交互式的，并且根据参与者的个人信仰和人口统计数据量身定制。
收到 TIWeb 的个人将获得信息，使他们能够致电并通过邮件接收 FOBT 工具包或安排适当的 CRC 测试和/或乳房 X 光检查。
|
干预：TIWeb 程序是交互式的，并根据参与者的个人信仰和人口统计数据量身定制。
收到 TIWeb 的个人将获得信息，使他们能够致电并通过邮件接收 FOBT 工具包或安排适当的 CRC 测试和/或乳房 X 光检查。
其他名称：
|
|
ACTIVE_COMPARATOR：癌症筛查电话 (CSC)
CSC - 电话咨询电话，在此期间参与者有机会完成 CRC 筛查（FOBT 或结肠镜检查）和/或乳房 X 光检查筛查。CSC 包括量身定制的咨询以及安排 BC 和 CRC 筛查测试的能力。
|
干预：CSC - 电话咨询电话，在此期间参与者有机会完成 CRC 筛查（FOBT 或结肠镜检查）和/或乳房 X 光检查筛查。CSC 包括量身定制的咨询以及安排 BC 和 CRC 筛查测试的能力。
其他名称：
|
|
ACTIVE_COMPARATOR：TIWeb+CSC
TIWeb + CSC（（量身定制的网络干预+癌症筛查）小组会收到邮寄的 TIWeb，CSC 会在接下来的四个星期内收到 FOBT 套件或安排结肠镜检查和/或乳房 X 光检查。
护士顾问知道参与者是筛选测试的良好候选人，将接受培训以安排 CRC 或 BC 筛选约会或将 FOBT 工具包邮寄给干预组中的个人，即使他们最近没有进行过门诊就诊。
|
干预：TIWeb + CSC（（量身定制的网络干预+癌症筛查）小组收到邮寄的 TIWeb，随后 4 周内 CSC 有同样的机会接收 FOBT 套件或安排结肠镜检查和/或乳房 X 光检查。
护士顾问知道参与者是筛选测试的良好候选人，将接受培训以安排 CRC 或 BC 筛选约会或将 FOBT 工具包邮寄给干预组中的个人，即使他们最近没有进行过门诊就诊。
其他名称：
|
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 |
|---|---|---|
|
主要结果 - 在控制基线时对 BC 筛查的依从性时，CRC 筛查依从性的差异，在随机分配到 1）常规护理的女性中； 2) 一个 TI 网络； 3) 一个 CSC，以及 4) 一个 TIWeb 加上一个 CSC。
大体时间：从基线测量起 6 个月
|
任何 CRC 检测（粪便检测或结肠镜检查） 接受粪便检测或结肠镜检查
|
从基线测量起 6 个月
|
|
主要结果：在控制基线时对 BC 筛查的依从性时，采用阶段（预先考虑、考虑、行动）的差异，在随机分配到 1）常规护理的女性中； 2) 一个 TI 网络； 3) 一个 CSC，以及 4) 一个 TIWeb 加上一个 CSC。
大体时间：从基线测量起 6 个月
|
前进阶段运动是理想的结果——在考虑 CRC 筛选时确定任何前进阶段运动，无论是从预想到沉思还是从预想到行动
|
从基线测量起 6 个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
次要结果：干预成本
大体时间：从基线测量起 6 个月
|
比较四种促进 CRC 和 BC 筛查的条件的成本效益，在随机接受 1) 常规护理的女性中，CRC 和 BC 筛查的依从性和采用阶段存在差异； 2) 一个 TI 网络； 3) 一个 CSC，以及 4) 一个 TIWeb 加上一个 CSC。
|
从基线测量起 6 个月
|
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：Victoria Champion, PhD、Indiana University School of Medicine
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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)
2010年7月22日
初级完成 (实际的)
2015年9月15日
研究完成 (实际的)
2017年5月31日
研究注册日期
首次提交
2017年8月22日
首先提交符合 QC 标准的
2017年9月8日
首次发布 (实际的)
2017年9月12日
研究记录更新
最后更新发布 (实际的)
2017年9月12日
上次提交的符合 QC 标准的更新
2017年9月8日
最后验证
2017年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 1009001808
- 5R01CA136940-05 (NIH)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
去识别化的 IPD 将通过受密码保护的符合 HIPAA 标准的数据存储系统（Box Health）提供给其他研究人员。
IPD 共享时间框架
2017年1月1日-2020年3月31日。
IPD 共享访问标准
仅与研究和/或正在撰写相关手稿的研究生或博士后学生相关的研究人员已获得首席研究员 Victoria Champion 的许可，可以提交请求。
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
加州大学的临床试验
-
Think Now IncorporatedUniversity of California, Berkeley; University of California, Los Angeles完全的
-
Göteborg UniversityWallström och Sjöbloms stiftelse; Peter Erikssons minnesfond; Back to Life完全的
-
Renmin Hospital of Wuhan UniversityWuhan Hamilton Biotechnology Co., Ltd未知