Clinical trial NCT06032338: Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering
Official title: 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]
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Screening
Participation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire
First posted: 2023-09-13
Enrollment: 64000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The number of study arms will differ according to age-group:

* 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.
Primary purpose: SCREENING

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:

* 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Participation to CRC screening program
timeFrame: 16 months after the invitation
measure: Performance of colonoscopy in FIT positive patients
timeFrame: 6 months after the positive FIT
Secondary outcomes:
measure: Participation to CRC screening program at 24 months
timeFrame: 24 months after invitation
measure: Time to screening participation
timeFrame: 24 months after invitation
measure: Colonoscopy in FIT positive patients, 12 months after the positive test
timeFrame: 12 months after the positive test
measure: Time to colonoscopy (in FIT positive patients)
timeFrame: 12 months after the positive test
measure: Colonoscopy findings
timeFrame: 12 months after the positive test
measure: Participation to CRC screening program in first invitees (50-51 yrs-old)
timeFrame: 16 months after invitation
measure: Cost-effectiveness analysis
timeFrame: 24 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Crcdc-Cvl
Study officials:
References: