Evaluation of the Home Delivery of the Screening Kit, and Impact of a Prior Notification Among New Participants to the National Organized Colorectal Cancer Screening Program (Among New Participants Only)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71,117
- 试验地点
- 6
- 主要终点
- Participation rates to the screening program
研究概览
简要总结
This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).
详细描述
The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up.
Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men aged 50 to 74 years old
- •Living in the study area (Departments of Ardennes, Meurthe-et-Moselle, and Moselle, France)
- •At moderate risk of colorectal cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)
排除标准
- •Outside the target age (less than 50 years old, or 75 years and more)
- •Receiving the reminder letter
- •At high or very high risk of colorectal cancer
结局指标
主要结局
Participation rates to the screening program
时间窗: 2 years
Comparison of the participation rate to the screening program between the intervention and the control arms
次要结局
- Referral rates to coloscopy among those FIT positive(2 years)
- Participation rates to the screening program(2 years)
研究者
Catherine Sauvaget
Dr
International Agency for Research on Cancer