Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System

Not Applicable

Completed

• Conditions: Cancer Colorectal
• Interventions: Behavioral: Reminder letter

• Registration Number: NCT02931825
• Lead Sponsor: University Hospital, Tours

Brief Summary

Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.

The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer

The project will be divided into 2 phases:

Objectives of the first phase:

* Identify high risk people for colorectal cancer in the department of Indre-et-Loire,

* Fill in as completely as possible their colonoscopic history in the past 5 years,

* Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).

Objective of the second phase:

Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Study Start: 2017-05-23
• Primary Completion: 2018-05-23
• Status Verified: 2019-05
• Study Completion: 2019-05-23
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7101

Inclusion Criteria

• residing in Indre et Loire (France)
• with increased risk for colorectal cancer
• who did not perform a colonoscopy in the past 58 months

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reminder letter	Reminder letter	A letter is sent for remind the importance of compliance with colonoscopy AND to encourage people to to consult their general practitioner or gastroenterologist (if they haven't done their follow-up in time).

Primary Outcome Measures

Name	Time	Method
Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms	12 months after sending the letter (/randomization)
Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years)	one year

Trial Locations

Locations (1)

UH Tours; 🇫🇷 Tours, Indre-et-Loire, France