EXPEDIT: Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering
Study Details
Study Description
Brief Summary
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:
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Method "B1": invitation with test sent to home without prior information letter
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Other: CRC screening invitation not including the screening test.
The invitation to CRC-PBOSP will only contain informations on how to get the screening test.
|
| 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. |
Other: Mailing of FIT with invitation
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. |
Other: Mailing of FIT with invitation
The invitation to CRC-PBOSP will contain the CRC screening test.
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Participation to CRC screening program [16 months after the invitation]
Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.
- Performance of colonoscopy in FIT positive patients [6 months after the positive FIT]
Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT
Secondary Outcome Measures
- Participation to CRC screening program at 24 months [24 months after invitation]
Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.
- Time to screening participation [24 months after invitation]
Time to screening participation within 24 months of invitation among invitees
- Colonoscopy in FIT positive patients, 12 months after the positive test [12 months after the positive test]
Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT
- Time to colonoscopy (in FIT positive patients) [12 months after the positive test]
Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT
- Colonoscopy findings [12 months after the positive test]
Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT
- Participation to CRC screening program in first invitees (50-51 yrs-old) [16 months after invitation]
Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)
- Cost-effectiveness analysis [24 months]
Costs of CSC-PBOSP from invitation to colonoscopy when necessary
Eligibility Criteria
Criteria
Inclusion Criteria:
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50 to 74 years old
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Resident of Centre Val de Loire French area
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Eligible for CRC screening invitation within the biennal CRC-PBOSP during the inclusion period
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Affiliated to the health insurance scheme
Exclusion Criteria:
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CRC screening exclusion criteria notified to CRCDC-CVL in a previous screening round (family or personal history of CRC/adenoma, inflammatory bowel disease)
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Colonoscopy in the previous 5 years)
Subjects refusing data transmission to research team will be excluded from statistical analyses.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Crcdc-Cvl | Tours | France | 37000 |
Sponsors and Collaborators
- University Hospital, Caen
- Institut National de la Santé Et de la Recherche Médicale, France
- Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-A01914-39