提高爱尔兰肠癌筛查率的干预措施:一项 2x2 析因试验
研究概览
详细说明
为了实现人口水平的健康收益,结直肠癌筛查计划需要高接受度。 指南建议摄入量为 65%-75%。 在爱尔兰,基于粪便免疫化学测试 (FIT) 的筛查吸收率远低于此(约 40%),尽管 FIT 被推荐为首选筛查测试,因为它有可能比其他测试提供更高的吸收率。 除了总体上不是最理想的情况外,爱尔兰的男性和社会经济地位较低的群体的摄入率明显较低,而这些群体正是结直肠癌潜在风险较高的群体。 虽然提高整体吸收率很重要,但还需要重点关注减少吸收率差异;如果任其发展,这些可能会导致风险最大人群的健康结果进一步差异。
爱尔兰筛查计划与采用率较高的计划之间的主要区别在于,BowelScreen 不会随筛查邀请发送测试套件:受邀者需要联系呼叫中心,同意参与并索取套件。 爱尔兰的接受率比苏格兰、荷兰和英格兰低 10-30%,事实上,在都柏林的试点筛选计划中也自动发送了测试。
在国际上,已经测试了各种提高吸收率的策略。 一些研究报告使用提前通知信、邮政邮寄家庭测试套件和电话联系增加了感染,但许多研究结果是否定的。 英国最近的研究指出了对初始筛查邀请的无反应者进行干预的潜力,但很少有干预研究关注无反应者。 现有研究的一个重要局限性是,大多数研究人员未能将他们的干预基于对影响个人关于筛查参与/不参与的决定的理解。
已经确定了一系列接受障碍,包括宿命论、知识匮乏、对癌症和筛查知之甚少以及对 FIT 筛查持消极态度、信念和情绪。 遵循复杂干预措施发展的 MRC 框架并在理论上知情,这项工作有明确的意图为未来的干预措施提供信息。
该提案旨在测试在无反应者中增加两种干预措施的有效性:1)包括带有当前提醒的测试套件,以及 2)基于证据和理论上知情的行为干预(例如 修改后的提醒信、修改后的随附传单)。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Dublin、爱尔兰
- National Screening Service
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
Irelands National BowelScreen Program 的所有新受邀者 60-64 岁的个人
排除标准:
所有在爱尔兰国家肠道筛查计划筛查年龄范围内的个人都有资格被纳入。
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:非随机化
- 介入模型:阶乘赋值
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:日常护理
仅标准提醒信
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实验性的:仅限增强型提醒信
行为增强提醒信
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增加基于 FIT 的结直肠癌筛查采用的行为干预
其他名称:
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实验性的:常规护理加测试套件
标准提醒函加试剂盒
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增加基于 FIT 的结直肠癌筛查采用的行为干预
其他名称:
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实验性的:增强提醒加测试套件
行为增强提醒信加测试套件
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增加基于 FIT 的结直肠癌筛查采用的行为干预
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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吸收
大体时间:干预实施后 3 个月
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每组参与率
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干预实施后 3 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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因剥夺、性别和年龄而吸收
大体时间:干预实施后 3 个月
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按剥夺、性别和年龄划分的每组参与率
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干预实施后 3 个月
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合作者和调查者
合作者
调查人员
- 首席研究员:Nicholas Clarke, PhD、DCU
出版物和有用的链接
一般刊物
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- Allison JE, Fraser CG, Halloran SP, Young GP. Population screening for colorectal cancer means getting FIT: the past, present, and future of colorectal cancer screening using the fecal immunochemical test for hemoglobin (FIT). Gut Liver. 2014 Mar;8(2):117-30. doi: 10.5009/gnl.2014.8.2.117. Epub 2014 Mar 11.
- Weller DP, Patnick J, McIntosh HM, Dietrich AJ. Uptake in cancer screening programmes. Lancet Oncol. 2009 Jul;10(7):693-9. doi: 10.1016/S1470-2045(09)70145-7.
- Essink-Bot ML, Dekker E. Equal access to colorectal cancer screening. Lancet. 2016 Feb 20;387(10020):724-6. doi: 10.1016/S0140-6736(15)01221-0. Epub 2015 Dec 9. No abstract available.
- BowelScreen. BowelScreen: Programme Statistical Bulletin 2016 - 2017 [Internet]. 2018 [cited 2019 Oct 29]. Available from: http://www.screeningservice.ie/publications/BowelScreen_statistical_bulletin_2016-2017_FINAL%203_7_19.pdf
- Digby J, McDonald PJ, Strachan JA, Libby G, Steele RJ, Fraser CG. Use of a faecal immunochemical test narrows current gaps in uptake for sex, age and deprivation in a bowel cancer screening programme. J Med Screen. 2013 Jun;20(2):80-5. doi: 10.1177/0969141313497197. Epub 2013 Jul 18.
- Vart G, Banzi R, Minozzi S. Comparing participation rates between immunochemical and guaiac faecal occult blood tests: a systematic review and meta-analysis. Prev Med. 2012 Aug;55(2):87-92. doi: 10.1016/j.ypmed.2012.05.006. Epub 2012 May 23.
- Clarke N, Sharp L, Osborne A, Kearney PM. Comparison of uptake of colorectal cancer screening based on fecal immunochemical testing (FIT) in males and females: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):39-47. doi: 10.1158/1055-9965.EPI-14-0774. Epub 2014 Nov 6.
- Clarke N, McNamara D, Kearney PM, O'Morain CA, Shearer N, Sharp L. The role of area-level deprivation and gender in participation in population-based faecal immunochemical test (FIT) colorectal cancer screening. Prev Med. 2016 Dec;93:198-203. doi: 10.1016/j.ypmed.2016.10.012. Epub 2016 Oct 18.
- Wardle J, Robb K, Vernon S, Waller J. Screening for prevention and early diagnosis of cancer. Am Psychol. 2015 Feb-Mar;70(2):119-33. doi: 10.1037/a0037357.
- Clarke N, Sharp L, O'Leary E, Richardson N. A report on the excess burden of cancer among men in the Republic of Ireland. 2013 [cited 2015 Aug 14]; Available from: https://www.lenus.ie/hse/handle/10147/316719
- NHS Highland. DPH Annual Report 2019 and appendices [Internet]. Scotland; 2019 [cited 2020 Jan 17]. Available from: https://www.nhshighland.scot.nhs.uk/Publications/Documents/DPH-Annual-Report-2019-and-appendices.pdf
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- Kerrison RS, McGregor LM, Marshall S, Isitt J, Counsell N, Wardle J, von Wagner C. Use of a 12 months' self-referral reminder to facilitate uptake of bowel scope (flexible sigmoidoscopy) screening in previous non-responders: a London-based feasibility study. Br J Cancer. 2016 Mar 29;114(7):751-8. doi: 10.1038/bjc.2016.43. Epub 2016 Mar 15.
- Clarke N, Gallagher P, Kearney PM, McNamara D, Sharp L. Impact of gender on decisions to participate in faecal immunochemical test-based colorectal cancer screening: a qualitative study. Psychooncology. 2016 Dec;25(12):1456-1462. doi: 10.1002/pon.4085. Epub 2016 Feb 11.
- Clarke N, Kearney PM, Gallagher P, McNamara D, O'Morain CA, Sharp L. Negative emotions and cancer fatalism are independently associated with uptake of Faecal Immunochemical Test-based colorectal cancer screening: Results from a population-based study. Prev Med. 2021 Apr;145:106430. doi: 10.1016/j.ypmed.2021.106430. Epub 2021 Jan 19.
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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