A Program for Improved Family Screening for Colorectal Cancer — COLOR3  

Colorectal Cancer Clinical Trial

Official title: A Program for Improved Family Screening for Colorectal Cancer

Status Recruiting

Clinical Trial Summary

A first- degree family history of colorectal cancer (CRC) or adenoma before age 65 is associated with a high risk of CRC. For these high-risk subjects, the French 2013 recommendations advise colonoscopy screening, but participation is insufficient (26-54%).The purpose of this project is to propose, through association of multidisciplinary research teams (public health, sociology, linguistic), actors on the field (physicians, organized screening facilities), and decision makers, relevant and effective interventions in the framework of a public health program, enabling increased participation of relatives of patients with CRC or adenoma before age 65 in targeted screening for CRC by colonoscopy.

Clinical Trial Description

A first-degree family history of colorectal cancer (CRC) or adenoma before age 65 is associated with a high risk of CRC. For these high-risk subjects, the French 2013 recommendations advise colonoscopy screening, but participation is insufficient (26-54%).The purpose of this project is to propose, through association of multidisciplinary research teams (public health, sociology, linguistic), actors on the field (physicians, organized screening facilities), and decision makers, relevant and effective interventions in the framework of a public health program, enabling increased participation of relatives of patients with CRC or adenoma before age 65 in targeted screening for CRC by colonoscopy.

Description of the intervention: This program, offered in 4 departments is divided into 3 phases:

1. Sensitization of doctors to the recommendations. This is a collaborative work with clinicians to enable them i) to take ownership of the problem and generic documents used in the previous study and ii) to define an intervention logic to encourage them to systematically inform subjects with RCC or advanced adenoma before age 65 the increased risk related to their 1st degree.

2. Coordinated transmission of information from the patient's physician to the relative's physician under consent of the patient and his/her relatives. Under the terms established with the actors in the previous phase, the physician delivers standard information to the index patient, presents the generic documents and may adapt the procedure to each patient's needs. With support of the coordination team which collects the coordinates of 1st degree relatives, the patient's physician transmits the information to the relatives and their doctors. The coordination team, during this experimental phase, will be the team of Epidemiology, Cancer Registry of Poitiers University Hospital, under the responsibility of public health physicians. The coordination team contacts each relative on behalf of the index patient's consent, acting by delegation of the index patient's physician, informs about the transmission of information given to the index patient, requests the agreement of the relative that the patient's doctor would contact his/her doctor to inform, under cover of professional secrecy, of the medical context.

3. Personalized information of relatives by a preventive nurse based on validated prevention models (individual psychosocial factors associated with screening and behavioral stage). At most two years after diagnosis of the index patient, the relative's colonoscopy performance status will be ascertained by the coordination team in connection with the attending physician. If the relative has had a colonoscopy carried out, the coordination team shall document the results and note the date scheduled for the following exam. If the relative has not had a colonoscopy carried out, he shall then receive a personalized intervention, based on the intervention evaluated in the previous study, as a supplement to the action of his/her doctor.

Qualitative and quantitative evaluations will follow each phase to measure the acceptability, coverage, efficiency, to assess transferability of the program. Moreover the program will be evaluated by a population survey conducted by the cancer registry that covers the geographical area of the experimentation with data collection that identify exhaustively the patients with CRC or high-grade adenoma. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT03620877
• Study type: Interventional
• Source: Poitiers University Hospital
• Contact: Pierre Ingrand, MD, PhD
• Phone: 33-5.49.45.43.45
• Email: pierre.ingrand@univ-poitiers.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2018
• Completion date: September 2021