- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03084133
Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives (EDUCANCOLAGE)
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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Angers, Frankrig
- Service d'Hépatogastro-entérologie CHU ANGERS
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Blois, Frankrig, 41 000
- Service d'Hépatogastro-entérologie CHG BLOIS
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Dreux, Frankrig
- Service d'Hépatogastro-entérologie CHG de DREUX
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Loches, Frankrig
- Service de Médecine CHG de Loches
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Nantes, Frankrig
- Service d'Hépatogastro-entérologie CHU de NANTES
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Orleans, Frankrig, 45067
- Service d'Hépatogastro-entérologie CHR d'Orléans
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Poitiers, Frankrig, 86 000
- Service d'Hépatogastro-entérologie CHU POITIERS
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Tours, Frankrig, 37044
- Service d'Hépatogastro-entérologie CHRU de TOURS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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' |
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).
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Ingen indgriben: 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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Tidsramme: 12 MONTHS
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Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
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12 MONTHS
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Tidsramme: 12 MONTHS
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Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
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12 MONTHS
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Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Tidsramme: 12 MONTHS
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Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
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12 MONTHS
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Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Tidsramme: 12 MONTHS
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Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
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12 MONTHS
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How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
Tidsramme: 12 MONTHS
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How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
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12 MONTHS
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Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Tidsramme: 2 MONTHS
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Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
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2 MONTHS
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Rate of colorectal cancer.
Tidsramme: 12 MONTHS
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Rate of colorectal cancer.
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12 MONTHS
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Rate of advanced adenomas.
Tidsramme: 12 MONTHS
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Rate of advanced adenomas.
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12 MONTHS
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Detection rate of scallop lesions.
Tidsramme: 12 MONTHS
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Detection rate of scallop lesions.
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12 MONTHS
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Rate of complications in screening colonoscopies.
Tidsramme: 12 MONTHS
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Rate of complications in screening colonoscopies.
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12 MONTHS
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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.
Tidsramme: 12 MONTHS
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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.
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12 MONTHS
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: CAROLI BOSC Françis- Xavier, Pr, University Hospital, Angers
- Ledende efterforsker: MATYSIAK-BUDNIK Tamara, Pr, CHU Nantes
- Ledende efterforsker: LANDAU Alain, Dr, CHG DREUX
- Ledende efterforsker: GARGOT Denis, Dr, CHG BLOIS
- Ledende efterforsker: BARBIEUX Jean- Pierre, Dr, CHG LOCHES
- Ledende efterforsker: TOUGERON David, Pr, CHU Poitiers
- Ledende efterforsker: LEGOUX Jean- Louis, Dr, CHR Orleans
- Ledende efterforsker: BOURGEOIS Hugues, Dr, Clinic Victor Hugo LE MANS
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Adenom
Andre undersøgelses-id-numre
- INCA14-TL/EDUCANCOLAGE
- 2015-A01514-45 (Anden identifikator: ID RCB)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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