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

Study Overview
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Brief Summary
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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.

Official Title
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Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening

Conditions
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Cancer Colorectal

Intervention / Treatment
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* Behavioral: Reminder letter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reminder letter<br>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). | Behavioral: Reminder letter<br>* The letter will consist in several parts: Reminder of : -the need of individual follow-up for high risk people for colorectal cancer AND - the general recommendations (one colonoscopy every 5 years) Recommendation to consult their general practitioner or gastroenterologist if they haven't done their follow up Request information if they've done their follow-up or if we have incorrect information Indication that the letter is sent as part of a surveillance program specific for high risk people for colorectal Cancer<br>|
| No Intervention: Control<br>No intervention (what is done currently) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms |  | 12 months after sending the letter (/randomization) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high risk, surveillance, screening, colonoscopy