Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To determine the relative proportions of women offered genetic testing after a breast cancer diagnosis who decide to have BRCA testing
研究概览
简要总结
Genes are the "blueprints" for our bodies. Some people are born with an abnormal copy ("mutation") of a gene. These people may have a higher chance of getting a disease. Different mutations in different genes cause different diseases. Some women get breast cancer because they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These women also have a higher chance of getting ovary cancer. Women with breast cancer and an abnormal copy of BRCA1 or BRCA2 also have a higher chance of getting a second breast cancer in their other breast. Because of this, women who might have a mutation may have genetic testing soon after their breast cancer diagnosis to learn about their risks of getting another cancer.
Genetic testing may be done right after a woman has been diagnosed with breast cancer. It may also be done later, after surgery is done to treat the cancer. The investigators do not know when it is best to do genetic testing. The investigators are doing this study to try to understand whether women prefer testing before or after surgery. The investigator also want to find out how they feel about their choice later on, when their diagnosis in more in their past.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of invasive breast cancer or DCIS
- •Appropriate for genetic testing, defined as if they meeting one or more of the following criteria (note that patients may be appropriate for genetic testing even if they do not meet these criteria, but NCCN and most payers recognize these groups as clearly appropriate for testing)
- •Must be a primary malignancy (not recurrence), but can be second diagnosis if is a contralateral cancer and the first cancer was not treated with mastectomy
- •Female age ≥18,
- •If Ashkenazi Jewish: Breast cancer diagnosis ≤
- •Subjects will be presumed to be of Ashkenazi ethnicity if Jewish religious preference is confirmed in subject and at least 1 parent, unless they explicitly endorse Sephardic, Iranian, Yemeni/Ethiopian, or Bukharan Jewish Decent, in which case non-Ashkenazi criteria will be applied.
- •If not Ashkenazi Jewish:
- •Breast cancer diagnosis ≤ 45 OR
- •Bilateral breast cancer, with first diagnosed ≤ 50 OR
- •Breast cancer diagnosed at any age with a male relative with breast cancer OR
- •Breast cancer diagnosis ≤ 50 with one or more of the following::
- •1 or more relative with breast cancer ≤ 50 or
- •1 or more relative with ovarian cancer
- •Have not completed definitive surgical treatment
- •For patients planning mastectomy for treatment, has not yet undergone mastectomy
- •For patients planning breast conservation for treatment, has not yet begun adjuvant radiation therapy
排除标准
- •LCIS without invasive cancer (IDC or ILC) and without DCIS
- •Previous breast cancer treated with mastectomy
- •Plan for neoadjuvant chemotherapy before surgery
- •Unable to complete English language questionnaires, as instruments have not been validated in non-English speaking populations
结局指标
主要结局
To determine the relative proportions of women offered genetic testing after a breast cancer diagnosis who decide to have BRCA testing
时间窗: 2 years
Either before completing definitive local surgical treatment (pre-surgical testing), after definitive surgical treatment (post-surgical) Women will be evaluated for their levels of general and cancer specific distress, coping style, and stage of decision-making with respect to PM (as this is the primary clinical reason for undergoing immediate testing).
次要结局
- To determine the relative proportions of women who decide to undergo prophylactic mastectomy (PM)(2 years)
- To assess the factors associated with the decision to choose pre- or post surgical testing.(2 years)