Interventions to Improve Bowel Cancer Screening Uptake in Ireland: a 2x2 Factorial Trial
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Detailed 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).
    

Intervention name(s): Behaviorally enhanced reminder letter
Intervention type(s): Behavioral
Intervention description(s): Behavioral interventions to increase FIT-based colorectal cancer screening uptake
Other intervention name(s): Direct mailing of FIT test kit; Behaviorally enhanced reminder letter and direct mailing of FIT kit
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Intervention model description: 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:
Usual care - Standard reminder and no test kit
Standard reminder plus test kit
Theoretically informed behavioural intervention (modified reminder letter) at reminder and no test kit
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.
Masking: Single (Participant)
Primary purpose: Screening
Keywords: colorectal cancer; Fecal Immunochemical test; cancer screening; Uptake; Participation