Colorectal Cancer
Conditions
Keywords
Screening, Participation
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).
Interventions
OTHERCRC screening invitation not including the screening test.
The invitation to CRC-PBOSP will only contain informations on how to get the screening test.
OTHERMailing of FIT with invitation
The invitation to CRC-PBOSP will contain the CRC screening test.
OTHERInformation 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.
Sponsors
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cost-effectiveness analysis | 24 months | Costs of CSC-PBOSP from invitation to colonoscopy when necessary |
| 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) |
Countries
France
Outcome results
None listed