Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland
PICCOLINO
Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)
1 other identifier
interventional
12,298
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2018
CompletedFirst Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
December 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedDecember 31, 2018
December 1, 2018
1.4 years
December 21, 2018
December 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Diagnostic yield for CRC and advanced adenomas
Within 18 weeks of enrollment
Study Arms (3)
Current screening practice.
NO INTERVENTIONSubjects 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.
Sequential screening strategy.
EXPERIMENTALSubjects 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.
EXPERIMENTALSubjects 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.
Interventions
Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.
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
You may qualify if:
- Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Poland
Related Publications (1)
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.
PMID: 33307024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 21, 2018
First Posted
December 31, 2018
Study Start
August 25, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
December 31, 2018
Record last verified: 2018-12