Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering (EXPEDIT)
EXPérimentation d'Envoi Postal DIrect à Domicile du kiT de dépistage du Cancer Colorectal Sans Commande préalable [Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering]
The effect of mailing FIT with the invitation on participation and colonoscopy rates will be evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region, involving 64,000 people from the population eligible for colorectal cancer population-based organised screening program (CRC-PBOSP).
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tours, France, 37000
- Crcdc-Cvl
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 50 to 74 years old
- 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:
- CRC screening exclusion criteria notified to CRCDC-CVL in a previous screening round (family or personal history of CRC/adenoma, inflammatory bowel disease)
- Colonoscopy in the previous 5 years)
Subjects refusing data transmission to research team will be excluded from statistical analyses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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. |
The invitation to CRC-PBOSP will only contain informations on how to get the screening test.
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Experimental: 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. |
The invitation to CRC-PBOSP will contain the CRC screening test.
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|
Experimental: 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. |
The invitation to CRC-PBOSP will contain the CRC screening test.
An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation to CRC screening program
Time Frame: 16 months after the invitation
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Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.
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16 months after the invitation
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Performance of colonoscopy in FIT positive patients
Time Frame: 6 months after the positive FIT
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Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT
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6 months after the positive FIT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation to CRC screening program at 24 months
Time Frame: 24 months after invitation
|
Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.
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24 months after invitation
|
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Time to screening participation
Time Frame: 24 months after invitation
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Time to screening participation within 24 months of invitation among invitees
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24 months after invitation
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Colonoscopy in FIT positive patients, 12 months after the positive test
Time Frame: 12 months after the positive test
|
Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT
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12 months after the positive test
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Time to colonoscopy (in FIT positive patients)
Time Frame: 12 months after the positive test
|
Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT
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12 months after the positive test
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Colonoscopy findings
Time Frame: 12 months after the positive test
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Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT
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12 months after the positive test
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Participation to CRC screening program in first invitees (50-51 yrs-old)
Time Frame: 16 months after invitation
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Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)
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16 months after invitation
|
|
Cost-effectiveness analysis
Time Frame: 24 months
|
Costs of CSC-PBOSP from invitation to colonoscopy when necessary
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A01914-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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