Genetic Testing for All Breast Cancer Patients (GET FACTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
研究概览
简要总结
This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer
This research study involves an expedited and surgery-specific form of genetic counseling.
The names of the study methods involved in this trial are/is:
- Quantitative genetic counseling (discussion is guided by tables and graphs)
- Standard genetic counseling
详细描述
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The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits
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After receiving genetic testing, participants will be placed into one of two counseling methodology groups:
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Standard genetic counseling: Standard of care discussion
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Quantitative genetic counseling: Discussion is guided by tables and graphs.
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Participants will be on the research study for up to six months, with an optional extension to two years.
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It is expected that about 450 people will participate.
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This research study is a Feasibility Study, which is the first-time investigators are examining this form of genetic counseling.
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This is a randomized study. Randomization means being put into a group by chance. It is like flipping a coin. Neither the participant nor the Investigator will choose the group the participant is assigned to.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a new breast cancer diagnosis (invasive or in-situ) considering genetic testing
- •Patients with good understanding of written and spoken English
- •Patients with apparent cognitive capacity to make surgical decisions for themselves
- •Patients who are medically cleared for surgery
- •Patients must be at least age 18 but under 79
排除标准
- •Previous breast cancer diagnosis (invasive or DCIS)
- •Metastatic breast cancer
- •Patients who have received prior broad-based panel testing (prior BRCA1/2 testing with negative results allowed)
- •Bilateral breast cancer
- •Known medical or surgical contraindication to contralateral mastectomy
- •Hematologic malignancy necessitating skin biopsy/fibroblast culture for germline genetic testing malignancy other than cervical cis or basal or squamous cell skin cancers.
研究组 & 干预措施
Quantitative Genetic Counseling
The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups:
-- Quantitative genetic counseling: Discussion is guided by tables and graphs.
干预措施: Quantitative Genetic Counseling (Behavioral)
STANDARD GENETIC COUNSELING
The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups:
-- Standard genetic counseling: Standard of care discussion
干预措施: Standard Genetic Counseling (Behavioral)
结局指标
主要结局
Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
时间窗: 1 month
Patient's will be surveyed about their personal propensity to choose a bilateral mastectomy as the surgical treatment of a unilateral cancer before and after quantitative vs. standard counseling. This survey question was self-developed in conjunction with the Dana Farber Cancer Institute professional survey core. The question reads: "How likely or unlikely are you to choose surgery to remove both breasts (bilateral mastectomy) for your cancer in one breast (unilateral or one-sided breast cancer)?"s answer options include the following: "Very unlikely, Somewhat unlikely, Unsure (neither likely nor unlikely), Somewhat likely, Very likely).
Change in patient's assessment of their personal contralateral breast cancer risk
时间窗: 1 month
A short survey, self-developed in conjunction with the Dana Farber Cancer Institute professional survey core, will be used to compare changes in patients' personal contralateral breast cancer (CBC) risk assessment after quantitative versus standard genetic counseling. The question reads: "By the time you turn 80 years old, what do you believe is the chance you will develop cancer in the other (unaffected) breast?" and answer options are in 10% increments (ie. 0-10%, 11-20%, 21-30%). Their individual assessment of their risk will be collected before and after genetic counseling and will be compared to CBCRisk (for those without gene mutations) or ASK2ME (for those with gene mutations).
次要结局
- Contralateral Prophylactic Mastectomy (CPM) Rate(6 Months)
- Genetic Testing Satisfaction(6 Months)
- Level of anxiety among participants, as measured by the PROMIS anxiety scale(6 months)
- Number of participants with decisional regret (testing and surgery choices)(6 months)
研究者
Laura S. Dominici, MD
Principal Investigator
Brigham and Women's Hospital