Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
2022年10月12日 更新者：Georgetown University
Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations.
The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care.
The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results.
Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention.
Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
369
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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District of Columbia
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Washington、District of Columbia、美国、20007
- Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
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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
21年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Undergo BRCA1/2 genetic counseling and testing at one of four study sites
- Receive positive or uninformative test results
- English speaking
Exclusion Criteria:
- Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
- Previous bilateral mastectomy
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：阶乘赋值
- 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：Mutation Carrier: Enhanced Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
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BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
This intervention is designed to provide education and decision support regarding the available risk management options.
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实验性的：Mutation Carrier: Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
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BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support.
This intervention is designed to provide education regarding the available risk management options.
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有源比较器：Mutation Carrier: Enhanced Print DA
BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.
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BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool.
This intervention is designed to provide education and decision support regarding the available risk management options.
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有源比较器：Mutation Carrier: Print DA
BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
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BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
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实验性的：Inconclusive Results: DA
Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making
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Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
This intervention is designed to provide education and decision support regarding the available risk management options.
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无干预：Inconclusive Results: Usual care
Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention
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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 |
|---|---|---|
|
Knowledge
大体时间：1-month post randomization
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Knowledge of risk management options.
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1-month post randomization
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Decision Conflict
大体时间：1-month post-randomization
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Decisional Conflict Scale
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1-month post-randomization
|
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Decision Satisfaction
大体时间：12-months post-randomization
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Satisfaction with Decision Scale
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12-months post-randomization
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Psychological Distress
大体时间：1-month post randomization
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1-month post randomization
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Health Related Quality of Life
大体时间：12-months post randomization
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SF-12
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12-months post randomization
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Utilization of breast and ovarian cancer risk management options
大体时间：12-months post-randomization
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We will assess uptake of the following risk management strategies:
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12-months post-randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Knowledge
大体时间：3-months post randomization
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Knowledge of risk management options
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3-months post randomization
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Psychological Distress
大体时间：3-months post-randomization
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3-months post-randomization
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Decisional Conflict
大体时间：3-months post-randomization
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Decisional Conflict Scale
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3-months post-randomization
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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：Marc D Schwartz, PhD、Georgetown University
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
2015年10月1日
初级完成 (实际的)
2022年7月1日
研究完成 (实际的)
2022年7月1日
研究注册日期
首次提交
2014年4月9日
首先提交符合 QC 标准的
2014年5月6日
首次发布 (估计)
2014年5月8日
研究记录更新
最后更新发布 (实际的)
2022年10月14日
上次提交的符合 QC 标准的更新
2022年10月12日
最后验证
2022年9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.