Colorectal Cancer
Conditions
Keywords
colorectal cancer, screening program, pilot project, randomised control trial, France
Brief summary
This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).
Detailed description
The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up. Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.
Interventions
OTHERDispatch of the screening test along the invitation letter to the national colorectal cancer screening program
The individuals eligible for the colorectal cancer screening program will receive at home an invitation letter to participate to the program along with a FIT test. The follow-up will be similar to the standard of care, i.e. reminder letters at 5 and 10 months if there is no participation, and reminders if no coloscopy after a positive FIT test
OTHERSending of a prior notification to the new entrants of the national program
Dispatch of a notification, one month prior the dispatch of the screening test along the invitation letter. This intervention is among the new entrants to the national program
Sponsors
International Agency for Research on Cancer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a three-arm study with a parallel study design
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* Women and men aged 50 to 74 years old * Living in the study area (Departments of Ardennes, Meurthe-et-Moselle, and Moselle, France) * At moderate risk of colorectal cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)
Exclusion criteria
* Outside the target age (less than 50 years old, or 75 years and more) * Receiving the reminder letter * At high or very high risk of colorectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation rates to the screening program | 2 years | Comparison of the participation rate to the screening program between the intervention and the control arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participation rates to the screening program | 2 years | Comparison of the participation rates to the screening program between the individuals aged 50-52 of the Intervention1 and the Intervention sub-study arms |
| Referral rates to coloscopy among those FIT positive | 2 years | Comparison of the referral rates to coloscopy between the intervention and the control arms |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMaurice TANGUY, MD
Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle site, Nancy, France
PRINCIPAL_INVESTIGATORMyriam GUERBAZ SOMMI, MD
Regional Cancer Screening Coordinating Centre, Moselle site, Metz, France
PRINCIPAL_INVESTIGATORJean BOTO KEKY, MD
Regional Cancer Screening Coordinating Centre, Ardennes site, Charleville-Mézières, France
Outcome results
None listed