Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland
NCT ID: NCT03790475
Last Updated: 2018-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12298 participants
INTERVENTIONAL
2018-08-25
2019-12-31
Brief Summary
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Within the study 12,298 eligible persons between 55 and 64 years of age will be drawn from the Population Registry and randomly assigned in a 1:1:1 ratio to receive an invitation to participate in one of the three screening strategies: (I) postal invitation to colonoscopy and a re-invitation to colonoscopy for initial non-responders, (II) postal invitation for screening using fecal immunochemical test (FIT) for non-responders and subjects refusing a colonoscopy, or (III) postal invitation offering a choice between FIT and colonoscopy.
Colonoscopies will be performed in seven local centers participating in the study. FITs will be analyzed in the central laboratory. Subjects with positive FIT result will be recommended to undergo colonoscopy.
The primary outcome is participation with CRC screening within 18 weeks after enrollment, defined as completion of colonoscopy, or completion of FIT along with colonoscopy for positive FIT result. Secondary outcome will be diagnostic yield for advanced neoplasia (CRC or advanced adenoma). The study has been approved by a local bioethics committee.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Current screening practice.
Subjects randomized into this group will receive named invitations for colonoscopy with pre-specified date, contact details of dedicated screening center. Invitations will be sent 6 weeks prior to suggested date of screening test. All subjects not responding to the invitation will receive a reminder letter 3 weeks prior to proposed appointment date. Additionally, a re-invitation for colonoscopy (screening test in 6 weeks) will be sent to participants not responding to the first invitation and the reminding letter.
No interventions assigned to this group
Sequential screening strategy.
Subjects randomized into this group will be initially invited to participate in a screening colonoscopy as per group 1. All subjects who will refuse colonoscopy or do not respond to invitation within 6 weeks since the first letter, will receive another invitation letter with FIT test enclosed.
The screening office will contact persons with a positive test result in order to determine the date of the colonoscopy appointment.
A negative test result will be sent together with a recommendation to have another screening test performed 2 years later and information about the possible delivery of the test in two years.
Offering an alternative colorectal cancer screening method
Persons randomized to the sequential screening strategy group will receive a postal invitation to the colonoscopy followed by a postal invitation for screening using FIT for non-responders and subjects refusing colonoscopy.
Multiple options screening strategy.
Subjects in this group will receive a letter with an offer to choose between colonoscopy or FIT screening.
The first letter will include an invitation with a scheduled date of colonoscopy (in 6 weeks) and a FIT kit.
Three weeks before a scheduled date of colonoscopy subjects randomized into this group will receive a reminder letter with an information about proposed screening methods. After the scheduled date of the colonoscopy examination, subjects who will not respond to the invitation for colonoscopy and will not send the FIT test back to the laboratory will receive another invitation for colonoscopy (in 6 weeks) and a FIT kit.
Offering a choice for colorectal cancer screening
Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.
Interventions
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Offering a choice for colorectal cancer screening
Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.
Offering an alternative colorectal cancer screening method
Persons randomized to the sequential screening strategy group will receive a postal invitation to the colonoscopy followed by a postal invitation for screening using FIT for non-responders and subjects refusing colonoscopy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* addressees of letters that have been returned by the post office.
* subjects requiring long-term care due to somatic, psychosocial reasons or with mental disability.
* history of colorectal resection.
55 Years
64 Years
ALL
No
Sponsors
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Ministry of Health, Poland
OTHER_GOV
Centre of Postgraduate Medical Education
OTHER
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Michal F. Kaminski, MD, PhD
MD, PhD
Locations
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Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Michal Filip Kaminski, MD, PhD
Role: primary
Nastazja Dagny Pilonis, MD
Role: backup
References
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Pilonis ND, Bugajski M, Wieszczy P, Rupinski M, Pisera M, Pawlak E, Regula J, Kaminski MF. Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study). Gastroenterology. 2021 Mar;160(4):1097-1105. doi: 10.1053/j.gastro.2020.11.049. Epub 2020 Dec 9.
Other Identifiers
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43/PB/2018
Identifier Type: -
Identifier Source: org_study_id