ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 995
- 试验地点
- 2
- 主要终点
- Number of Participants Taking Chemoprevention at 12 Months
研究概览
简要总结
This trial will test a decision support web based intervention for women at increased risk for breast cancer due to breast density and other risk factors (age, race/ethnicity, family history of breast cancer, history of prior breast biopsies), and to consider MRI and/or chemoprevention to manage their breast cancer risk.
详细描述
Along with better-known risk factors such as family history having dense breasts is one of the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of women, with an additional third having heterogeneously dense breasts. Women in these categories have 3-6 times the risk of breast cancer as compared to women with least density. Although breast density is measured on routine screening mammograms, it is not typically communicated to patients. This is changing as a result of legal mandates and approaches need to be tested to effectively integrate this clinical information in care. Therefore,we have developed an intervention to support decision making about cancer risk management (MRI and chemoprevention) for women at clinically elevated risk using a web-based intervention that will evaluate the efficacy of a web based intervention with personalized risk information communication versus usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, aged 40-69
- •Enrolled at Group Health
- •Have had a negative mammogram as part of their routine care
- •Either (a) an intermediate 5-year risk (>1.67%-2.49%) and extremely dense breasts or (b) a high 5-year risk (≥2.50%) and either heterogeneously dense or extremely dense breasts utilizing the Breast Cancer Surveillance Consortium Risk Calculator (http://tools.bcsc-scc.org/BC5yearRisk/)
- •Women must also have a valid email address.
排除标准
- •Not able to speak and read English
- •History of LCIS
- •Prior cancer diagnosis (including DCIS)
- •Known BRCA1/2 family mutation, or previous receipt of cancer genetic counseling
- •Do not want to be contacted for research
- •Have previously participated in intervention development activities
- •Dis-enrolled from health plan between mammogram and start of recruitment.
结局指标
主要结局
Number of Participants Taking Chemoprevention at 12 Months
时间窗: 12 months
Number of Participants who initiated chemoprevention is measured as receipt of any prescription for tamoxifen or raloxifene, based on health plan pharmacy data at any time from consent through 12 months.
次要结局
- Distress Related to Cancer Risk(6 weeks and 12 months)
- Number of Participants Receiving Breast MRI(12 months)
研究者
Suzanne C. O'Neill
Associate Professor
Georgetown University