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FIT for purpose: personalised surveillance colonoscopy for people at increased risk of colorectal cancer.

Not Applicable
Recruiting
Conditions
Bowel cancer surveillance
Colorectal Cancer
Cancer - Bowel - Back passage (rectum) or large bowel (colon)
Public Health - Health service research
Registration Number
ACTRN12619001743156
Lead Sponsor
Flinders University of South Australia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
4500
Inclusion Criteria

Inclusion Groups 1 & 2:
•Males and females enrolled in the SCOOP clinical CRC surveillance program.
•Aged older than 18 years.
•Individuals who have either had a previous colonoscopy finding of adenoma or those with a significant family history of colorectal cancer (CRC).
•Individuals with a colonoscopy surveillance interval of at least three years.

Further inclusion for Group 1 only: (to be randomised into control or intervention arms)
•Those due for surveillance colonoscopy 2019 to 2023.
•Individuals with a zero FIT result within the last 3 years.

Further inclusion for Group 2 only: (for a single survey)
•Individuals not scheduled for a surveillance colonoscopy during the study period.

Exclusion Criteria

Exclusion:
•Individuals under 18 years of age.
•Individuals with a familial syndrome or inflammatory bowel disease (IBD).
•Individuals who have had bowel cancer surgery with resection.
•Individuals with the indication for colonoscopy being a positive interval FIT.
•Individuals with a colonoscopy surveillance interval less than three years.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Burden of having a colonoscopy as assessed by study-specific colonoscopy costing survey.<br><br>[ All participants in Group 1 only: Assessed 6 months post colonoscopy.];To determine the safety of extending colonoscopy schedules by one-third, in intervention arm, by including interval Faecal Immunochemical Test (FIT) as evidenced by the decreased presence of advanced neoplasia as assessed by colonoscopy.[ Group 1: Intervention arm - Assessed 6 months post colonoscopy.]
Secondary Outcome Measures
NameTimeMethod
Participant acceptance of extending colonoscopy surveillance intervals as assessed from the Discrete Choice Experiment Surveys before and after colonoscopy.[ All participants in Group 1 only: Assessed 6 months post colonoscopy.]
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