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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Angers, Frankrike
- Service d'Hépatogastro-entérologie CHU ANGERS
-
Blois, Frankrike, 41 000
- Service d'Hépatogastro-entérologie CHG BLOIS
-
Dreux, Frankrike
- Service d'Hépatogastro-entérologie CHG de DREUX
-
Loches, Frankrike
- Service de Médecine CHG de Loches
-
Nantes, Frankrike
- Service d'Hépatogastro-entérologie CHU de NANTES
-
Orleans, Frankrike, 45067
- Service d'Hépatogastro-entérologie CHR d'Orléans
-
Poitiers, Frankrike, 86 000
- Service d'Hépatogastro-entérologie CHU POITIERS
-
Tours, Frankrike, 37044
- Service d'Hépatogastro-entérologie CHRU de TOURS
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
|
|
Inget ingripande: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Tidsram: 12 MONTHS
|
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
|
12 MONTHS
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Tidsram: 12 MONTHS
|
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
|
12 MONTHS
|
|
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Tidsram: 12 MONTHS
|
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
|
12 MONTHS
|
|
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Tidsram: 12 MONTHS
|
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
|
12 MONTHS
|
|
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
Tidsram: 12 MONTHS
|
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
|
12 MONTHS
|
|
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Tidsram: 2 MONTHS
|
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
|
2 MONTHS
|
|
Rate of colorectal cancer.
Tidsram: 12 MONTHS
|
Rate of colorectal cancer.
|
12 MONTHS
|
|
Rate of advanced adenomas.
Tidsram: 12 MONTHS
|
Rate of advanced adenomas.
|
12 MONTHS
|
|
Detection rate of scallop lesions.
Tidsram: 12 MONTHS
|
Detection rate of scallop lesions.
|
12 MONTHS
|
|
Rate of complications in screening colonoscopies.
Tidsram: 12 MONTHS
|
Rate of complications in screening colonoscopies.
|
12 MONTHS
|
|
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.
Tidsram: 12 MONTHS
|
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.
|
12 MONTHS
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: CAROLI BOSC Françis- Xavier, Pr, University Hospital, Angers
- Huvudutredare: MATYSIAK-BUDNIK Tamara, Pr, CHU Nantes
- Huvudutredare: LANDAU Alain, Dr, CHG DREUX
- Huvudutredare: GARGOT Denis, Dr, CHG BLOIS
- Huvudutredare: BARBIEUX Jean- Pierre, Dr, CHG LOCHES
- Huvudutredare: TOUGERON David, Pr, CHU Poitiers
- Huvudutredare: LEGOUX Jean- Louis, Dr, CHR Orléans
- Huvudutredare: BOURGEOIS Hugues, Dr, Clinic Victor Hugo LE MANS
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolorektala neoplasmer
- Adenom
Andra studie-ID-nummer
- INCA14-TL/EDUCANCOLAGE
- 2015-A01514-45 (Annan identifierare: ID RCB)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .