Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland
- Conditions
- Colorectal Cancer
- Interventions
- Other: Offering an alternative colorectal cancer screening methodOther: Offering a choice for colorectal cancer screening
- Registration Number
- NCT03790475
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12298
Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program .
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequential screening strategy. Offering an alternative colorectal cancer screening method 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. Multiple options screening strategy. Offering a choice for colorectal cancer screening 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.
- Primary Outcome Measures
Name Time Method Completion of the assigned screening strategy within 18 weeks of enrollment 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.
- Secondary Outcome Measures
Name Time Method Diagnostic yield for CRC and advanced adenomas Within 18 weeks of enrollment Advanced adenoma defined as adenoma \>1 cm in size, or with high-grade dysplasia, or with villous component (\>25%).
Trial Locations
- Locations (1)
Maria Sklodowska-Curie Institute - Oncology Center
🇵🇱Warsaw, Poland