Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling
研究概览
简要总结
This study assesses breast cancer screening adherence for women at moderately increased risk for developing breast cancer based on gene mutation status or empiric risk model estimates. It also seeks to determine facilitators and barriers to screening.
详细描述
PRIMARY OBJECTIVE:
I. Among women without a history of breast cancer: to compare women with moderate risk breast cancer gene mutations (Mutation Carrier Group) to women with a 20-40% empiric lifetime risk of breast cancer (Empiric Risk Group) in terms of how likely they are to undergo recommended breast MRI screening.
OUTLINE: This is an observational study.
Patients complete a questionnaire and have their medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •* >= 30 years
- •=< 75 years
- •Women with either:
- •Genetic test results showing moderately increased breast cancer risk due to a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, or RAD51D (Mutation carrier group) OR
- •Calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model (Empiric risk group)
- •Patients provided breast cancer risk assessments by genetic counselors at USC Norris or LA General Hospital beginning in 2021 and at least 12 months ago
- •Women recommended to undergo annual breast MRI and/or annual mammogram beginning at the time of their genetic counseling risk assessment
- •English or Spanish speaking patients
排除标准
- •* History of breast cancer before genetic counseling at University of Southern California (USC)
- •Any metastatic cancer diagnosis at time of genetic counseling risk assessment
- •Patient underwent a risk reducing mastectomy before their genetic counseling risk assessment
研究组 & 干预措施
Observational
Patients complete a questionnaire and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling
时间窗: Up to 2 years
Will be calculated for each of the 4 Hospital-by-Age subgroups for the 2 risk groups; then a one-sided, α=0.05 Mantel Haenszel test, stratifying by hospital and age, will be used to compare the Mutation Carrier Risk and the Empiric Risk groups in terms of adherence to screening MRI. Homogeneity of odds ratios will be tested to ensure that difference (odds ratio) between the two risk groups is fairly consistent across the 4 strata.
次要结局
未报告次要终点