4R (Right Information and Right Care to the Right Patient at the Right Time) for Guideline Indicated BRCA Genetic Assessment of Breast Center Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The timing of genetic testing in regards to what kind of surgery was performed
研究概览
简要总结
Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery or at a time point that does not allow them to use testing results in making their surgical decision. Diagnostics, decisions and interventions are often out of sequence, resulting in test information not available in time for decisions. Tests are often repeated. Decisions and interventions are delayed, are not understood by breast cancer patients or proceed without the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005, Katz SJ 2007, IOM 2001).
In this study, BRCA testing information will be delivered to patients at the point of breast imaging. For patients that are diagnosed with breast cancer, this provides ample time to use the test results in making their surgical decision, if they elect to be tested. The investigators will work with health care providers to insure family history data are collected at the breast imaging visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population, and coordinate scheduling with genetic counseling services to insure patients are promptly seen.
The investigators hypothesis is that an intervention of providing patients indicated for genetic/familial risk with timely information and opportunity to access genetic counseling during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for patients with a breast cancer diagnosis, and could impact surgical decisions. The investigators will identify barriers to this intervention from the perspective of patients, physicians, nurses, and genetic counselors. The investigators will then adjust the intervention to overcome the barriers and will test the intervention at the point where genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at breast imaging. If indicated, patients will be provided information and will be referred to genetic counseling to consider BRCA tests.
详细描述
This study is expected to involve a total of 2,101 individuals: 89 (83 for testing the intervention and 6 who participated in interviews like Northwestern staff participants) breast cancer patients, 12 Northwestern staff,and 2,000 women who consented and participated in the genetics assessment screening survey using the tool, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.
All subjects will be assigned a unique study number to minimize the risk of a breach of confidentiality. This is the only anticipated risk to subjects participating in this study utilizing retrospective and prospective chart reviews and interviews.
TESTING THE INTERVENTION
Investigators will collect retrospective data for 83 breast cancer patients diagnosed who underwent BRCA testing and definitive breast cancer surgery at Northwestern between 07/01/2008 to 06/30/2010. This baseline information detailed on the Data Collection Form will be collected using EDW and NMFF and NMH medical record systems.
The intervention involves radiologists who convey pathology results to patients with suspected breast cancers. At the time the patient with a familial/ genetic risk is informed of a positive test result for breast cancer, the radiologist will provide information about genetic counseling and offer to send an educational handout via e-mail or regular mail. This intervention will be conducted with newly diagnosed breast cancer patients between 03/01/2011and 05/31/2012.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Retrospective chart review of 83 breast cancer patients:
- •Age 18 and older
- •Diagnosed with invasive breast cancer at Northwestern between 07/01/2008 and 06/30/2010
- •Prospective chart review of 83 patients:
- •Age 18 and older
- •Diagnosed with invasive breast cancer at Northwestern between 03/01/2011 and 05/31/2012
- •For patient interviews:
- •Age 18 and older
- •Are not inpatients
- •Patients seen at the Lynn Sage Comprehensive Breast Center
- •For staff interviews:
- •Members of the Northwestern staff to include but not limited the Lynn Sage Comprehensive Breast Cancer Center and/or Breast Cancer Genetics Program provider staff (including physicians, nurses, schedulers, physician assistants and/or genetic counselors)
排除标准
- •Under 18 years of age
- •To test the intervention, patients seen at the breast center:
- •Are female
- •Are age 18 and older
- •Are not institutionalized
- •Are being seen at the Lynn Sage Comprehensive Breast Center
- •Have a positive family history per NCCN guidelines on genetic/familial high risk assessment for breast and ovarian cancer
- •Exclusion Criteria:
- •Under 18 years of age
结局指标
主要结局
The timing of genetic testing in regards to what kind of surgery was performed
时间窗: 12 months
To test an intervention for breast center patients with familial/genetic risk by obtaining data on 2,000 women who consented and participated in the genetics assessment screening survey, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.
次要结局
- Impact of the intervention(36 months)
研究者
Melissa Simon
Associate Professor
Northwestern University