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Clinical Trials/NCT03383367
NCT03383367UnknownNot Applicable

Extending the Prerogatives of Colorectal Cancer Screening French Organizations to the Follow-up After Colonoscopy of Patients Aged 50 or More: Pilot Study in the Rhône Administrative Department

Association pour le Dépistage Organisé des Cancers dans le Rhône2 sites in 1 country33,000 target enrollmentStarted: August 24, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
33,000
Locations
2
Primary Endpoint
participation rate at future colonoscopy

Study Overview

Brief Summary

France is one of the European countries where the incidence of colorectal cancer is the highest among cancers for both sexes. Fecal occult blood screening has been implemented since 2008. However, this screening excludes high risk people who have a 10 to 30 % risk of developing a CRC during their lifetime. Colonoscopy follow up of these persons is not organized, and it is up to the attending physician to recall the date of the surveillance colonoscopy. This results in a poor compliance with the recommendations by these people. A postal reminder of the surveillance colonoscopies sent by The French screening organizations to the patients should increase adherence to follow-up recommendations. The colorectal cancer screening organizations will collects from the hepatogastroenterologists (HGE) informations on colonoscopies of people more than 50 years old who live in the Rhone. These informations will allow to send a reminder 3 months before the date recommended by the HGE. Participation rate and timeliness will be assessed, as well as the severity of the lesions found. A medico-economic analysis will also be carried out.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • people aged 50 years or more ;
  • at high risk of colorectal cancer ;
  • living in Rhône administrative departement or Metropolitan Lyon

Exclusion Criteria

  • person with chronic inflammatory bowel disease
  • colorectal cancer in diagnosis or treatment period

Arms & Interventions

Tempo Colo

Experimental

Intervention: Tempo Colo (Behavioral)

Outcomes

Primary Outcomes

participation rate at future colonoscopy

Time Frame: At time of evaluation we will check the colonoscopy realized at six months after sending the letter at the person

participation rate at future colonoscopy that is the number of patient that really have colonoscopy among the patients who receive a reminder letter The systematic registry of colonoscopies will permit to assess if a patient performs it.

Secondary Outcomes

  • description of lesions severities found at surveillance colonoscopy after letter reminder(Lesions'severity will be evaluated at 6, 9 or 15 months following the reminder sent according to the colonoscopist's recommendation (1,3 or 5 years after reference exams). By the way of systematic registration. .)
  • Cost-utility analysis of the reminder letter for surveillance colonoscopy(Lesions'severity will be evaluated at 6, 9 or 15 months following the reminder sent according to the colonoscopist's recommendation (1,3 or 5 years after reference exams). The costs will be registered at the same time.)

Investigators

Sponsor
Association pour le Dépistage Organisé des Cancers dans le Rhône
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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