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

NCT05609396 | Completed

• 1 other identifier: BSA_012
• Study Type: interventional
• Target: 8,734
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; Fecal Immunochemical test; cancer screening; Uptake; Participation

Outcome Measures

Primary Outcomes (1)

• Uptake

  Participation rate in each arm

  3 months from intervention delivery

Secondary Outcomes (1)

• Uptake by deprivation, sex and age

  3 months from intervention delivery

Study Arms (4)

Usual care

NO INTERVENTION

Standard reminder letter only

Enhanced reminder letter only

EXPERIMENTAL

Behaviorally enhanced reminder letter

Behavioral: Behaviorally enhanced reminder letter

Usual care plus test kit

EXPERIMENTAL

Standard reminder letter plus test kit

Behavioral: Behaviorally enhanced reminder letter

Enhanced reminder plus test kit

EXPERIMENTAL

Behaviorally enhanced reminder letter plus test kit

Behavioral: Behaviorally enhanced reminder letter

Interventions

Behaviorally enhanced reminder letter BEHAVIORAL

Behavioral interventions to increase FIT-based colorectal cancer screening uptake

Also known as: Direct mailing of FIT test kit, Behaviorally enhanced reminder letter and direct mailing of FIT kit

Enhanced reminder letter only; Enhanced reminder plus test kit; Usual care plus test kit

Eligibility Criteria

• Age: 60 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dublin City University: lead
• The National Screening Service: collaborator
• Newcastle University: collaborator
• University College, London: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

National Screening Service

Dublin, Ireland

Location

Related Publications (24)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nicholas Clarke, PhD

  DCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a 2x2 factorial design non-randomised control trial. This design will test main effects of each intervention and investigate whether the two interventions interact (25). Individuals between the ages of 60-62 (new invitees) will be sampled from invitees who do not respond to the initial screening invitation and allocated to one of four trial arms using batch randomisation. The four trial arms will be: 1. Usual care - Standard reminder and no test kit 2. Standard reminder plus test kit 3. Theoretically informed behavioural intervention (modified reminder letter) at reminder and no test kit 4. Theoretically informed behavioural intervention at reminder with test kit The main effect of the test kit is estimated by comparing 2+4 vs 1+3; main effect of behavioural intervention is estimated from 3+4 vs 1+2.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: May 3, 2022
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)