Latinas LEarning About Density (LLEAD Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,386
- 试验地点
- 3
- 主要终点
- Knowledge of Breast Density as a Masking Factor at First Follow-up
研究概览
简要总结
This study will examine behavioral and psychological outcomes of breast density notification using a 3-group randomized design comparing usual written notification to two educationally enhanced approaches.
详细描述
This is a 3-group randomized clinical trial to compare usual care to two educationally enhanced approaches to breast density notification. Usual care involves sending written notification along with the mammogram report; all women will receive usual care. In addition, some women will receive written educational materials about breast density, with or without interaction with a promotora (culturally congruent health educator). Study outcomes include short and long term assessments of psychological (anxiety, knowledge) and behavioral (continued mammography screening, discussion with primary care provider) outcomes. The study also includes qualitative inquiry and a cost analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Attending screening mammography at Mountain Park Health Center
- •Speak English or Spanish
排除标准
- •Current diagnosis of breast cancer
研究组 & 干预措施
Usual Care
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
Enhanced
Usual Care plus a written educational brochure
干预措施: Written educational brochure (Behavioral)
Interpersonal
Usual Care plus Enhanced plus interaction with a promotora (lay health educator)
干预措施: Written educational brochure (Behavioral)
Interpersonal
Usual Care plus Enhanced plus interaction with a promotora (lay health educator)
干预措施: Promotora interaction (Behavioral)
结局指标
主要结局
Knowledge of Breast Density as a Masking Factor at First Follow-up
时间窗: Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)
Percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response at T1 Comparisons of the difference between the intervention groups in percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response to the question at T1
Anxiety Short Term (Baseline T0 to First Follow-up T1)
时间窗: Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end
The State-Trait Anxiety Inventory-State (STAI-S) s a 20-item self-report assessment. Items are answered on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so), with the total score ranging from 20 to 80, with higher scores indicating higher levels of anxiety symptoms. Anxiety was dichotomized as: normal (STAI score \< 30) or moderate to severe (STAI score ≥ 30). The primary outcome was the percentage of participants who maintained or decreased to 'normal' anxiety levels at T1 from T0.
BC Risk Assessment - Survey
时间窗: T0 (baseline) to T1 (14 to 180 days after completion of education)
Percentage of women who provided incorrect response at baseline (T0) but a correct response at 14 to 180 days after completion of education to the question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know). Comparisons of the difference in percentage of women who provided correct response to the single question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know) between intervention groups.
次要结局
未报告次要终点