Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
2012年8月7日 更新者：Judy E. Garber, MD、Dana-Farber Cancer Institute
A Randomized Study of Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations.
The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.
研究概览
详细说明
- Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
- Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
- Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
- Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
- In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.
研究类型
介入性
注册 (实际的)
150
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
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
-
-
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 及以上 (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:
- 18 years of age or older
- Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
- Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
- Documentation of key family member cancer diagnoses is required
Exclusion Criteria:
- Males, will be offered BRCA 1/2 testing through other protocols
- Individuals unable to speak or write English
- Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
- Life expectancy of less than 12 months.
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
- 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 |
|---|---|
|
有源比较器：Genetic Counseling
|
Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent.
These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
|
|
有源比较器：Informed Consent Counseling
|
Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent.
These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing.
大体时间：5 years
|
5 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To compare the financial costs incurred in the implementation of the two models and examine the utilization of medical and mental health services by participants in each condition during the follow-up period.
大体时间：5 years
|
5 years
|
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。
合作者
调查人员
- 首席研究员：Judy Garber, MD、Dana-Farber Cancer Institute
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
1998年7月1日
初级完成 (实际的)
2001年9月1日
研究完成 (实际的)
2005年6月1日
研究注册日期
首次提交
2005年9月9日
首先提交符合 QC 标准的
2005年9月9日
首次发布 (估计)
2005年9月14日
研究记录更新
最后更新发布 (估计)
2012年8月9日
上次提交的符合 QC 标准的更新
2012年8月7日
最后验证
2012年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 98-120
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.