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临床试验/NCT05609396
NCT05609396已完成不适用

Interventions to Improve Bowel Cancer Screening Uptake in Ireland: a 2x2 Factorial Trial

Dublin City University1 个研究点 分布在 1 个国家目标入组 8,734 人开始时间: 2022年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8,734
试验地点
1
主要终点
Uptake

研究概览

简要总结

High uptake is vital to population-based screening. BowelScreen (Irelands national organised population-based colorectal cancer screening programme) has not achieved recommended screening uptake targets. In Ireland sending the test kit in the screening invitation reminder may be an important strategy in targeting non-responders and would address a key difference between Ireland and other international screening programmes with higher uptake. In addition, few studies have focused on behavioural barriers to screening participation. Founded upon the MRC Guidelines for the Development of Complex Interventions, our systematic, theoretically-informed investigation of FIT screening participation has begun to identify behavioural antecedents to screening participation in Ireland. This study will implement a multilevel evidence-based, theoretically-informed intervention which includes the automatic inclusion of the test kit in the screening reminder, alone and in combination with an intervention to influence individuals' screening participation. This multilevel intervention will provide recommendations for the screening invitation delivery, potentially bringing the programme closer to recommended uptake targets (50%) and in the long-term influence reductions in bowel cancer incidence and mortality in Ireland.

详细描述

To achieve population-level health gains, colorectal cancer screening programmes require high uptake. Guidelines recommend uptake of 65%-75%. In Ireland, faecal immunochemical test (FIT)-based screening uptake is considerably lower than this (around 40%), despite FIT being recommended as the screening test of choice given its potential to deliver higher uptake than other tests. As well as being suboptimal overall, uptake in Ireland is significantly lower among males and lower socioeconomic groups the very groups at higher underlying risk of colorectal cancer. While improving overall uptake is important, focus is also needed on reducing differentials in uptake; left unchecked these may lead to further disparities in health outcomes among those most at risk.

The main difference between Ireland's screening programme and programmes with higher uptake is that BowelScreen does not send the test kit with the screening invitation: invitees are required to contact a call-centre, consent to participate and request the kit. Uptake in Ireland is 10-30% lower than Scotland, the Netherlands and England and, indeed, in a pilot screening programme in Dublin that also sent the test automatically.

Internationally, various strategies to improve uptake have been tested. Some studies report increases using advance notification letters, postal mailing of home-based testing kits, and telephone contacts but many studies have been negative. Recent UK research points to potential in intervening among non-responders to the initial screening invitation, but few intervention studies have focussed on non-responders. An important limitation of existing studies is that most investigators failed to base their interventions on an understanding of what influences individuals' decisions about screening participation/non-participation.

A range of barriers to uptake have been identified and include fatalism, poor knowledge, being poorly informed about cancer and screening and holding negative attitudes, beliefs and emotions towards FIT screening. Following the MRC Framework for the Development of Complex Interventions and being theoretically informed, this work has the explicit intention of informing future interventions.

This proposal seeks to test efficacy in increasing uptake of two interventions among non responders: 1) including a test kit with the current reminder, and 2) an evidence-based and theoretically informed behavioural intervention (e.g. modified reminder letter, modified accompanying leaflet).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All new invitees of Irelands National BowelScreen Programme Individuals aged 60-64

排除标准

  • •All individuals who are within the screening age range of Irelands national bowel screening programme are eligible to be included.

研究组 & 干预措施

Usual care

No Intervention

Standard reminder letter only

Enhanced reminder letter only

Experimental

Behaviorally enhanced reminder letter

干预措施: Behaviorally enhanced reminder letter (Behavioral)

Usual care plus test kit

Experimental

Standard reminder letter plus test kit

干预措施: Behaviorally enhanced reminder letter (Behavioral)

Enhanced reminder plus test kit

Experimental

Behaviorally enhanced reminder letter plus test kit

干预措施: Behaviorally enhanced reminder letter (Behavioral)

结局指标

主要结局

Uptake

时间窗: 3 months from intervention delivery

Participation rate in each arm

次要结局

  • Uptake by deprivation, sex and age(3 months from intervention delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Clarke

Principal Investigator

Dublin City University

研究点 (1)

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