Pilot Study for Implementing Breast Cancer Early Detection Programs in Colombia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,855
- 试验地点
- 2
- 主要终点
- Breast cancer Incidence
研究概览
简要总结
A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to evaluate the effects of an opportunistic (hospital-based) screening program (intervention) vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or control arm (N=13). At intervention clinics general practitioners were instructed to perform clinical breast examination (CBE) on all women aged 50-69 years attending clinics for non-breast health related issues, and to refer them for mammographic screening. Physicians from control clinics were not specifically instructed to perform breast-screening or refer women for mammography, but could do so if they thought it appropriate ('usual care'). Women were followed for 2 years post-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Aged 50-69 Resident in Bogotá, Colombia or surrounding cities; Had not had a mammogram in the previous two years; No history of breast cancer Attending health-centers for reasons unrelated to breast health
排除标准
- •see above
结局指标
主要结局
Breast cancer Incidence
时间窗: Two years
Comparing incidence of breast cancer in women randomized to the opportunistic breast screening arm, compared to women in the control arm.
次要结局
未报告次要终点