Time Schedules for Sending Invitations to Colonoscopy Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Participation rate
研究概览
简要总结
The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy.
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
- 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
- 否
入选标准
- •Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.
排除标准
- •Resident abroad
- •Return of unopened letter of invitation and/or reminder (address unknown)
- •Message from neighbour/family/post office on death of screenee (not updated in Population Registry).
- •Exclusion criteria for colonoscopy:
- •Individuals with previous colorectal surgery (resections, enterostomies)
- •Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
- •On-going cytotoxic treatment or radiotherapy for malignant disease
- •Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
- •Lifelong anticoagulant therapy with Warfarin
- •A coronary event requiring hospitalization during the last 3 months
- •A cerebrovascular event during the last 3 months
研究组 & 干预措施
Six and three time schedule
干预措施: Six and three time schedule (Other)
Four and two time schedule
干预措施: Four and two time schedule (Other)
结局指标
主要结局
Participation rate
时间窗: 6 months from the date of sending invitation letter
Percentage of attenders to screening colonoscopy.
次要结局
- Acceptance rate in SIX &THREE group(3 weeks from the date of sending invitation letter)
- Acceptance rate in FOUR&TWO group(2 weeks from the date of sending invitation letter, respectively)
- Response rate in SIX&THREE group(3 weeks from the date of sending invitation letter)
- Response rate in FOUR&TWO group(2 weeks from the date of sending invitation letter)