Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering

NCT06032338 | Active Not Recruiting

• 1 other identifier: 2022-A01914-39
• Study Type: interventional
• Target: 64,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

Screening; Participation

Outcome Measures

Primary Outcomes (2)

• Participation to CRC screening program

  Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.

  16 months after the invitation

• Performance of colonoscopy in FIT positive patients

  Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT

  6 months after the positive FIT

Secondary Outcomes (7)

• Participation to CRC screening program at 24 months

  24 months after invitation

• Time to screening participation

  24 months after invitation

• Colonoscopy in FIT positive patients, 12 months after the positive test

  12 months after the positive test

• Time to colonoscopy (in FIT positive patients)

  12 months after the positive test

• Colonoscopy findings

  12 months after the positive test

Study Arms (3)

Control "C"

OTHER

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.

Intervention "B1"

EXPERIMENTAL

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

Intervention "B2"

EXPERIMENTAL

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; Other: Information letter before invitation

Interventions

CRC screening invitation not including the screening test. OTHER

The invitation to CRC-PBOSP will only contain informations on how to get the screening test.

Control "C"

Mailing of FIT with invitation OTHER

The invitation to CRC-PBOSP will contain the CRC screening test.

Intervention "B1"; Intervention "B2"

Information letter before invitation OTHER

An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.

Intervention "B2"

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 74 years old
• Resident of Centre Val de Loire French area
• Affiliated to the health insurance scheme

You may not qualify if:

• Colonoscopy in the previous 5 years)
• Subjects refusing data transmission to research team will be excluded from statistical analyses.

Sponsors & Collaborators

• University Hospital, Caen: lead
• Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Crcdc-Cvl

Tours, 37000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: September 13, 2023
• Study Start: September 14, 2023
• Primary Completion: April 14, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)