Clinical trial NCT03084133: Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives
Official title: Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives - Randomized, Multicenter Cluster Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Colorectal
Keywords: Therapeutic education strategy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
name: Nantes University Hospital
name: Centre Hospitalier de Dreux
name: Hospital BLOIS
name: Hospital LOCHES
name: Poitiers University Hospital
name: UNIVERSITY HOSPITAL, ORLEANS
name: Clinic LE MANS
First posted: 2017-03-20
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "Intervention group" means a screening information and education system in which the particularities of the index cases likely to require adaptation of the device will be collected, analyzed and taken into account.

"Control group": provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the case-index according to its usual practice and adapted to the level of understanding of Case-index.
Primary purpose: PREVENTION

Brief summary: The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.

The main reason for this low participation rate is that most patients undergoing RCC or advanced adenoma are unaware of the family implications of their diagnosis and therefore reluctant to disseminate this information to their patients Related matters. The need for a better perception of the personal risk of CRC in first-degree relatives of patients with CRC or advanced adenoma, with the expected coronary adherence to increasing screening, requires a good understanding of risk through Clear, adapted and comprehensible information that can be relayed personally by the case-index.

The objective of this project is to develop a personalized prevention and screening program for the JRC in order to meet the needs of the relatives of the sick. The means of intervention that will be implemented respond to the need to better take into account the level of CRC risk in a family-based CRC screening and prevention approach adapted to a high-risk CRC group characterized by Family history at the first stage of CRC or advanced adenoma and, consequently, to improve the information of the subjects concerned by screening and prevention of CRC.

The aim of the case-index education is to induce its intervention with its relatives to promote CCR screening. The use of the index case, as a means of providing information to relatives, implies an educational and psychological approach, based on evidence, but adapted and personalized.

Detailed description: The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.

Eligibility criteria: List of inclusion criteria

Index case:

* Patients with colorectal adenocarcinoma or advanced adenoma diagnosed (definition of advanced adenoma (Winawer, 2006): adenoma of diameter ≥ 10 mm and / or severe dysplasia and / or with a villous contingent).
* Patients with at least one relative of the first degree belonging to the target population of the screening strategy evaluated (between 40 and 75 years of age and less than 10 years of age of the case-index) and residing in France.
* Affiliation of the patient to a social security scheme (including CMU).
* Understanding of the French language.

Related:

* They correspond to the target population at high risk of colorectal cancer targeted by this program of promotion of colonoscopy screening:
* Subjects related to 1st degree to the index case and in contact with it.
* Age between 40 and 75 years of age or less than 10 years of age of the index case.
* Resides in France

List of exclusion Criteria :

Index case :

* Chronic inflammatory bowel disease.
* Genetic predisposition syndrome identified with colorectal cancer (Lynch syndrome, familial polyposis linked to the APC and MYH genes).
* Patient's knowledge of a first-degree relative with colorectal adenocarcinoma or advanced adenoma.
* Isolated patient of his / her first-degree relatives and not wishing to re-establish contact with them.
* Advanced colorectal cancer with a life expectancy \<6 months and / or a WHO ≥ 2 general condition.
* Transmission of information to the family already carried out.

Related :

- Not applicable

Primary outcomes:
measure: Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
timeFrame: 12 MONTHS
Secondary outcomes:
measure: Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
timeFrame: 12 MONTHS
measure: Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
timeFrame: 12 MONTHS
measure: Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
timeFrame: 12 MONTHS
measure: How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
timeFrame: 12 MONTHS
measure: Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
timeFrame: 2 MONTHS
measure: Rate of colorectal cancer.
timeFrame: 12 MONTHS
measure: Rate of advanced adenomas.
timeFrame: 12 MONTHS
measure: Detection rate of scallop lesions.
timeFrame: 12 MONTHS
measure: Rate of complications in screening colonoscopies.
timeFrame: 12 MONTHS
measure: Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.
timeFrame: 12 MONTHS
Other outcomes:
Locations:
city: Angers
country: France
facility: Service d'Hépatogastro-entérologie CHU ANGERS
city: Blois
country: France
facility: Service d'Hépatogastro-entérologie CHG BLOIS
city: Dreux
country: France
facility: Service d'Hépatogastro-entérologie CHG de DREUX
city: Loches
country: France
facility: Service de Médecine CHG de Loches
city: Nantes
country: France
facility: Service d'Hépatogastro-entérologie CHU de NANTES
city: Orleans
country: France
facility: Service d'Hépatogastro-entérologie CHR d'Orléans
city: Poitiers
country: France
facility: Service d'Hépatogastro-entérologie CHU POITIERS
city: Tours
country: France
facility: Service d'Hépatogastro-entérologie CHRU de TOURS
Study officials:
affiliation: University Hospital, Angers
name: CAROLI BOSC Françis- Xavier, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: MATYSIAK-BUDNIK Tamara, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHG DREUX
name: LANDAU Alain, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHG BLOIS
name: GARGOT Denis, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHG LOCHES
name: BARBIEUX Jean- Pierre, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Poitiers
name: TOUGERON David, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR ORLEANS
name: LEGOUX Jean- Louis, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic Victor Hugo LE MANS
name: BOURGEOIS Hugues, Dr
role: PRINCIPAL_INVESTIGATOR
References: