跳至主要内容
临床试验/NCT02188927
NCT02188927Unknown不适用

Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial

Maria Sklodowska-Curie National Research Institute of Oncology1 个研究点 分布在 1 个国家目标入组 6,800 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
6,800
试验地点
1
主要终点
Participation rate

研究概览

简要总结

Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. It is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program.

We hypothesize that an Advance Notification Letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program.

This randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone.

Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.

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
55 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • all individuals aged 55-64 years living in the counties covered with the organized CRC screening program and assigned to invitation to screening colonoscopy in the year 2014 are eligible for the study.

排除标准

  • message from neighbor/family/post office on death of screenee (not updated in Population Registry)
  • resident abroad (not updated in Population Registry)
  • return of unopened letter of invitation and/or reminder (address unknown)
  • diagnosis of CRC before the date of draw (not updated in the National Cancer Registry)

结局指标

主要结局

Participation rate

时间窗: three months after receiving invitation

A percentage of invitees who undergo the screening colonoscopy. The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.

次要结局

  • Response rate(three months after receiving invitation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验