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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05609396
• Other study ID #: BSA_012
• Status: Completed
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: October 24, 2022

Study information

• Verified date: November 2022
• Source: Dublin City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8734
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Behaviorally enhanced reminder letter
Behavioral interventions to increase FIT-based colorectal cancer screening uptake

Locations

Country	Name	City	State
Ireland	National Screening Service	Dublin

Sponsors (5)

Lead Sponsor	Collaborator
Dublin City University	Newcastle University, The National Screening Service, University College, London, University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

References & Publications (24)

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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. — View Citation

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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

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Hirst Y, Stoffel S, Baio G, McGregor L, von Wagner C. Uptake of the English Bowel (Colorectal) Cancer Screening Programme: an update 5 years after the full roll-out. Eur J Cancer. 2018 Nov;103:267-273. doi: 10.1016/j.ejca.2018.07.135. Epub 2018 Sep 7. — View Citation

Issaka RB, Avila P, Whitaker E, Bent S, Somsouk M. Population health interventions to improve colorectal cancer screening by fecal immunochemical tests: A systematic review. Prev Med. 2019 Jan;118:113-121. doi: 10.1016/j.ypmed.2018.10.021. Epub 2018 Oct 24. — View Citation

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. — View Citation

McNamara D, Leen R, Seng-Lee C, Shearer N, Crotty P, Neary P, Walsh P, Boran G, O'Morain C. Sustained participation, colonoscopy uptake and adenoma detection rates over two rounds of the Tallaght-Trinity College colorectal cancer screening programme with the faecal immunological test. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1415-21. doi: 10.1097/MEG.0000000000000207. — View Citation

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Rat C, Latour C, Rousseau R, Gaultier A, Pogu C, Edwards A, Nguyen JM. Interventions to increase uptake of faecal tests for colorectal cancer screening: a systematic review. Eur J Cancer Prev. 2018 May;27(3):227-236. doi: 10.1097/CEJ.0000000000000344. — View Citation

Sabatino SA, Lawrence B, Elder R, Mercer SL, Wilson KM, DeVinney B, Melillo S, Carvalho M, Taplin S, Bastani R, Rimer BK, Vernon SW, Melvin CL, Taylor V, Fernandez M, Glanz K; Community Preventive Services Task Force. Effectiveness of interventions to increase screening for breast, cervical, and colorectal cancers: nine updated systematic reviews for the guide to community preventive services. Am J Prev Med. 2012 Jul;43(1):97-118. doi: 10.1016/j.amepre.2012.04.009. Review. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake	Participation rate in each arm	3 months from intervention delivery
Secondary	Uptake by deprivation, sex and age	Participation rate in each arm by deprivation, sex and age	3 months from intervention delivery