Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,101
- 试验地点
- 2
- 主要终点
- Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms
研究概览
简要总结
Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.
The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer
The project will be divided into 2 phases:
Objectives of the first phase:
- Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
- Fill in as completely as possible their colonoscopic history in the past 5 years,
- Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).
Objective of the second phase:
Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.
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
- 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
- 否
入选标准
- •residing in Indre et Loire (France)
- •with increased risk for colorectal cancer
- •who did not perform a colonoscopy in the past 58 months
排除标准
- 未提供
研究组 & 干预措施
Reminder letter
A letter is sent for remind the importance of compliance with colonoscopy AND to encourage people to to consult their general practitioner or gastroenterologist (if they haven't done their follow-up in time).
干预措施: Reminder letter (Behavioral)
Control
No intervention (what is done currently)
结局指标
主要结局
Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms
时间窗: 12 months after sending the letter (/randomization)
Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years)
时间窗: one year
次要结局
未报告次要终点