Exploring the utility and acceptability of Faecal immunochemical testing (FIT) as a novel intervention for the improvement of colorectal Cancer (CRC) surveillance in individuals with lynch syndrome (FIT for lynch study): a single-arm, prospective, multi-centre, non-randomised study

Table 1 Study schedule of events (baseline & years 1-3)

Study Participants (SP)	Active Recruitment (initial 12 months post study start)	Screening (7-30 days prior to colonoscopy)	Baseline (7-30 days prior to colonoscopy)	1-year post-baseline	2-years post-baseline	3-years post-baseline
Eligibility assessment		x
^α Patient Inquiry Letter and reply slip	x
FIT Kit, FIT instruction sheet, patient letter, patient information sheet (mailed)			x	x	x	x
Study invitation letter, consent form, baseline questionnaire, patient information sheet			x
Post-baseline letter				x	x	x
^‡Follow-up Questionnaire						x
SOC colonoscopy			+		+
**Colonoscopy referred via 2WW				**+		**+

x Research related procedure.
+ SOC procedure (as per recommended guidelines)
α Optional mailing for study sites who may not have access to requisite colonoscopy appointment data (direct mailing between said study sites and LS patients).
^‡ A follow-up questionnaire to assess evolving perceptions and attitudes towards FIT is presently under development as of the time of this writing and will be forthcoming for inclusion within the study design ahead of its planned distribution to study participants at Year 3
** Enrolled patients shall be referred for a colonoscopy (by their consultant) via the two-week wait (2WW) pathway performed at intervening years between SOC biennial colonoscopy (Years 1 &3) only in the event their FIT result ≥6 μg/g f-Hb

ISSN: 1471-2407