title: Comparison of mailed invitation strategies to improve fecal occult blood test participation in men: protocol for a randomized controlled trial.
abstract: BACKGROUND
  Men have a significantly increased risk of being diagnosed with, and dying from, colorectal cancer (CRC) than women. Men also participate in fecal occult blood test (FOBT) screening at a lower rate than women. This study will determine whether strategies that target men's attitudes toward screening, and matched to stage of readiness to screen, increase men's FOBT participation compared to a standard approach.
  
  
  METHODS
  Eligible trial participants will be a national sample of 9,200 men aged 50 to 74 years, living in urban Australia and randomly selected from the Australian electoral roll. Trial participants will be mailed an advance notification letter, followed 2 weeks later by an invitation letter and a free fecal immunochemical test (FIT) kit. The intervention is a factorial design, randomized controlled trial (RCT) with four trial arms, including a control. The content of the advance notification and invitation letters will differ by trial arm as follows: 1) standard advance notification and standard invitation (control arm); 2) targeted advance notification and standard invitation; 3) standard advance notification and targeted invitation; and 4) targeted advance notification and targeted invitation. The standard letters will replicate as closely as possible the letters included in the Australian National Bowel Cancer Screening Program (NBCSP). Modified advance notification and invitation letters will incorporate additional messages to target men in the precontemplation (advance notification) and contemplation stages (invitation). The primary outcome is return of the completed FIT within 12 weeks of invitation. Analysts will be blinded to trial assignment and participants will be blinded to the use of varying invitational materials. Subsamples from each trial arm will complete baseline and endpoint surveys to measure the psychological impact of the intervention, and qualitative interviews will be conducted to evaluate attitudes toward the intervention.
  
  
  CONCLUSIONS
  The outcomes of this study will have implications for the way FOBT screening is offered to men. Findings will help to identify how invitations for men to screen should be framed and delivered in order to maximize participation.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12612001122842.
authors.affiliation: School of Psychology, The University of Adelaide, Adelaide 5005, South Australia, Australia. amy.duncan@adelaide.edu.au
authors.forename: Amy
authors.initials: A
authors.lastname: Duncan
authors.forename: Ian
authors.initials: I
authors.lastname: Zajac
authors.forename: Ingrid
authors.initials: I
authors.lastname: Flight
authors.forename: Benjamin J R
authors.initials: BJ
authors.lastname: Stewart
authors.forename: Carlene
authors.initials: C
authors.lastname: Wilson
authors.forename: Deborah
authors.initials: D
authors.lastname: Turnbull
mesh_terms: D000368:Aged; D001315:Australia; D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D015709:Correspondence as Topic; D003695:Delivery of Health Care; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009780:Occult Blood; D010342:Patient Acceptance of Health Care; D011177:Postal Service; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012107:Research Design; D013997:Time Factors
chemical_list: D011933:Reagent Kits, Diagnostic
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