Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering
NCT ID: NCT06032338
Last Updated: 2023-12-22
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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RECRUITING
NA
64000 participants
INTERVENTIONAL
2023-09-14
2026-11-14
Brief Summary
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In the "C" control group, invitations, test delivery and reminders will be carried out in accordance with the CRC-PBOSP rules at the time of the study.
Intervention group "B" will evaluate two experimental modes of invitation with direct home mailing of the test:
* Method "B1": invitation with test sent to home without prior information letter
* Method "B2": information letter followed by invitation with test sent home, designed to optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for the first time.
Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a few general practitioners, gastroenterologists and invitees), 2/ on social and geographical inequalities of participation on a subsample of individuals included in EXPEDIT study using ecological indices (EDI, SCALE).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* In 50 or 51 yrs age-group, individuals (n=5760 ) will be randomised in 3 groups: C, B1 and B2 (allocation ratio 2:1:1)
* In the age-group older than 51 yrs, individuals (n=58240) will be randomised in 2 groups: C, and B1 (allocation 1:1) In the main analysis including both age-groups, B1 and B2 arms would be pooled.
SCREENING
NONE
Study Groups
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Control "C"
Usual care : Screening test (Fecal immunochemical test - FIT) delivery and reminders will be carried out in accordance with the Colorectal cancer population-based organised screening program (CRC-PBOSP) specifications at the time of the study.
This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.
CRC screening invitation not including the screening test.
The invitation to CRC-PBOSP will only contain informations on how to get the screening test.
Intervention "B1"
FIT mailed at home within the CRC screening invitation without prior information letter.
This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.
Mailing of FIT with invitation
The invitation to CRC-PBOSP will contain the CRC screening test.
Intervention "B2"
FIT mailed at home within the CRC screening invitation with prior information letter.
This arm is suitable for the first screening round in 50-51 years old population only.
Mailing of FIT with invitation
The invitation to CRC-PBOSP will contain the CRC screening test.
Information letter before invitation
An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.
Interventions
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CRC screening invitation not including the screening test.
The invitation to CRC-PBOSP will only contain informations on how to get the screening test.
Mailing of FIT with invitation
The invitation to CRC-PBOSP will contain the CRC screening test.
Information letter before invitation
An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.
Eligibility Criteria
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Inclusion Criteria
* Resident of Centre Val de Loire French area
* Eligible for CRC screening invitation within the biennal CRC-PBOSP during the inclusion period
* Affiliated to the health insurance scheme
Exclusion Criteria
Subjects refusing data transmission to research team will be excluded from statistical analyses.
50 Years
74 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire
UNKNOWN
University Hospital, Caen
OTHER
Responsible Party
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Locations
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Crcdc-Cvl
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Julie BOYARD, ScD
Role: primary
Other Identifiers
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2022-A01914-39
Identifier Type: -
Identifier Source: org_study_id