Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy

NCT03383367 | Unknown DMC

• 1 other identifier: 2016-A01710-51
• Study Type: interventional
• Target: 33,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

mass screening; colonoscopy surveillance; high risk patients

Outcome Measures

Primary Outcomes (1)

• participation rate at future colonoscopy

  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.

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

Secondary Outcomes (2)

• 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.

Study Arms (1)

Tempo Colo

EXPERIMENTAL

Behavioral: Tempo Colo

Interventions

Tempo Colo BEHAVIORAL

Reminder letter for people at high risk of colorectal cancer.

Tempo Colo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Association pour le Dépistage Organisé des Cancers dans le Rhône: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Adémas-69

Lyon, Rhône, 69005, 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: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective interventional study to evaluate the impact of a reminder sent by the Adémas-69 organization to improve coloscopy surveillance and compliance with recommendations for high risk of colorectal cancer people.

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 26, 2017
• Study Start: August 24, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

FR (1)