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Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives (EDUCANCOLAGE)

Primary Purpose

Cancer Colorectal

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic Education Strategy
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Colorectal focused on measuring Therapeutic education strategy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Hépatogastro-entérologie CHU ANGERS
  • Service d'Hépatogastro-entérologie CHG BLOIS
  • Service d'Hépatogastro-entérologie CHG de DREUX
  • Service de Médecine CHG de Loches
  • Service d'Hépatogastro-entérologie CHU de NANTES
  • Service d'Hépatogastro-entérologie CHR d'Orléans
  • Service d'Hépatogastro-entérologie CHU POITIERS
  • Service d'Hépatogastro-entérologie CHRU de TOURS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Education Strategy

Control group

Arm Description

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. Intervention 'Therapeutic Education Strategy'

Provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the index case according to its usual practice

Outcomes

Primary Outcome Measures

Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.

Secondary Outcome Measures

Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Rate of colorectal cancer.
Rate of colorectal cancer.
Rate of advanced adenomas.
Rate of advanced adenomas.
Detection rate of scallop lesions.
Detection rate of scallop lesions.
Rate of complications in screening colonoscopies.
Rate of complications in screening colonoscopies.
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.
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.

Full Information

First Posted
February 28, 2017
Last Updated
September 25, 2019
Sponsor
University Hospital, Tours
Collaborators
University Hospital, Angers, Nantes University Hospital, Centre Hospitalier de Dreux, Hospital BLOIS, Hospital LOCHES, Poitiers University Hospital, UNIVERSITY HOSPITAL, ORLEANS, Clinic LE MANS
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1. Study Identification

Unique Protocol Identification Number
NCT03084133
Brief Title
Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives
Acronym
EDUCANCOLAGE
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
January 19, 2019 (Actual)
Study Completion Date
January 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
University Hospital, Angers, Nantes University Hospital, Centre Hospitalier de Dreux, Hospital BLOIS, Hospital LOCHES, Poitiers University Hospital, UNIVERSITY HOSPITAL, ORLEANS, Clinic LE MANS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Colorectal
Keywords
Therapeutic education strategy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Education Strategy
Arm Type
Experimental
Arm Description
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. Intervention 'Therapeutic Education Strategy'
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the index case according to its usual practice
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Education Strategy
Intervention Description
In the experimental arm of the study ("intervention group"), a screening information and education system will be implemented. The particularities of the index cases likely to require an adaptation of the device will be collected, analyzed and taken into account (level of health literacy, socio-economic status, level of education, professional activity ...). The analysis and intervention frameworks derived from theories on health behaviors will be mobilized (theory of reasoned action, theory of planned behaviors) and applied in order to reinforce the "intention" of the target audience. The analysis and intervention frameworks resulting from the educational sciences will be integrated with a "competence" approach (Aizen, 1991, Denovel, Dufour, Prochaska, 1983, Le Boterf, 2002).
Primary Outcome Measure Information:
Title
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Description
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Description
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Time Frame
12 MONTHS
Title
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Description
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Time Frame
12 MONTHS
Title
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Description
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Time Frame
12 MONTHS
Title
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
Description
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
Time Frame
12 MONTHS
Title
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Description
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Time Frame
2 MONTHS
Title
Rate of colorectal cancer.
Description
Rate of colorectal cancer.
Time Frame
12 MONTHS
Title
Rate of advanced adenomas.
Description
Rate of advanced adenomas.
Time Frame
12 MONTHS
Title
Detection rate of scallop lesions.
Description
Detection rate of scallop lesions.
Time Frame
12 MONTHS
Title
Rate of complications in screening colonoscopies.
Description
Rate of complications in screening colonoscopies.
Time Frame
12 MONTHS
Title
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.
Description
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.
Time Frame
12 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAROLI BOSC Françis- Xavier, Pr
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MATYSIAK-BUDNIK Tamara, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LANDAU Alain, Dr
Organizational Affiliation
CHG DREUX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
GARGOT Denis, Dr
Organizational Affiliation
CHG BLOIS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BARBIEUX Jean- Pierre, Dr
Organizational Affiliation
CHG LOCHES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
TOUGERON David, Pr
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LEGOUX Jean- Louis, Dr
Organizational Affiliation
CHR ORLEANS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BOURGEOIS Hugues, Dr
Organizational Affiliation
Clinic Victor Hugo LE MANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hépatogastro-entérologie CHU ANGERS
City
Angers
Country
France
Facility Name
Service d'Hépatogastro-entérologie CHG BLOIS
City
Blois
ZIP/Postal Code
41 000
Country
France
Facility Name
Service d'Hépatogastro-entérologie CHG de DREUX
City
Dreux
Country
France
Facility Name
Service de Médecine CHG de Loches
City
Loches
Country
France
Facility Name
Service d'Hépatogastro-entérologie CHU de NANTES
City
Nantes
Country
France
Facility Name
Service d'Hépatogastro-entérologie CHR d'Orléans
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Service d'Hépatogastro-entérologie CHU POITIERS
City
Poitiers
ZIP/Postal Code
86 000
Country
France
Facility Name
Service d'Hépatogastro-entérologie CHRU de TOURS
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives

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