Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland

Study Overview
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Brief Summary
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The PICCOLINO is a randomized health services study performed within the framework of the Polish Colonoscopy Screening Program (PCSP) in Poland. 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.

Official Title
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Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Offering a choice for colorectal cancer screening
* Other: Offering an alternative colorectal cancer screening method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program . Exclusion Criteria: information of a selected subject death informed by family, neighbors or post office that has not been included in the Personal Identity Number (PESEL) system. 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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Current screening practice.<br>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. | |
| Experimental: Sequential screening strategy.<br>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. | Other: Offering an alternative colorectal cancer screening method<br>* 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.<br>|
| Experimental: Multiple options screening strategy.<br>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. | Other: Offering a choice for colorectal cancer screening<br>* Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of the assigned screening strategy within 18 weeks of enrollment | Completion of the assigned screening strategy within 18 weeks of enrollment defined as: current screening strategy: documented screening colonoscopy, sequential and multiple options strategies: documented colonoscopy, or receipt of FIT containing stool specimen. A positive FIT result requires subsequent documented colonoscopy to qualify as completed. | Within 18 weeks of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield for CRC and advanced adenomas | Advanced adenoma defined as adenoma >1 cm in size, or with high-grade dysplasia, or with villous component (>25%). | Within 18 weeks of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer Screening