Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives
NCT ID: NCT03084133
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2017-04-10
2019-01-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
"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.
PREVENTION
NONE
Study Groups
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Therapeutic Education Strategy
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'
Therapeutic Education Strategy
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).
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 index case according to its usual practice
No interventions assigned to this group
Interventions
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Therapeutic Education Strategy
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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
75 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Nantes University Hospital
OTHER
Centre Hospitalier de Dreux
OTHER
Hospital BLOIS
UNKNOWN
Hospital LOCHES
UNKNOWN
Poitiers University Hospital
OTHER
UNIVERSITY HOSPITAL, ORLEANS
UNKNOWN
Clinic LE MANS
UNKNOWN
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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CAROLI BOSC Françis- Xavier, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
MATYSIAK-BUDNIK Tamara, Pr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
LANDAU Alain, Dr
Role: PRINCIPAL_INVESTIGATOR
CHG DREUX
GARGOT Denis, Dr
Role: PRINCIPAL_INVESTIGATOR
CHG BLOIS
BARBIEUX Jean- Pierre, Dr
Role: PRINCIPAL_INVESTIGATOR
CHG LOCHES
TOUGERON David, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU Poitiers
LEGOUX Jean- Louis, Dr
Role: PRINCIPAL_INVESTIGATOR
CHR ORLEANS
BOURGEOIS Hugues, Dr
Role: PRINCIPAL_INVESTIGATOR
Clinic Victor Hugo LE MANS
Locations
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Service d'Hépatogastro-entérologie CHU ANGERS
Angers, , France
Service d'Hépatogastro-entérologie CHG BLOIS
Blois, , France
Service d'Hépatogastro-entérologie CHG de DREUX
Dreux, , France
Service de Médecine CHG de Loches
Loches, , France
Service d'Hépatogastro-entérologie CHU de NANTES
Nantes, , France
Service d'Hépatogastro-entérologie CHR d'Orléans
Orléans, , France
Service d'Hépatogastro-entérologie CHU POITIERS
Poitiers, , France
Service d'Hépatogastro-entérologie CHRU de TOURS
Tours, , France
Countries
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Other Identifiers
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2015-A01514-45
Identifier Type: OTHER
Identifier Source: secondary_id
INCA14-TL/EDUCANCOLAGE
Identifier Type: -
Identifier Source: org_study_id
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