Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

25 september 2019 bijgewerkt door: University Hospital, Tours

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

68

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Angers, Frankrijk
        • Service d'Hépatogastro-entérologie CHU ANGERS
      • Blois, Frankrijk, 41 000
        • Service d'Hépatogastro-entérologie CHG BLOIS
      • Dreux, Frankrijk
        • Service d'Hépatogastro-entérologie CHG de DREUX
      • Loches, Frankrijk
        • Service de Médecine CHG de Loches
      • Nantes, Frankrijk
        • Service d'Hépatogastro-entérologie CHU de NANTES
      • Orleans, Frankrijk, 45067
        • Service d'Hépatogastro-entérologie CHR d'Orléans
      • Poitiers, Frankrijk, 86 000
        • Service d'Hépatogastro-entérologie CHU POITIERS
      • Tours, Frankrijk, 37044
        • Service d'Hépatogastro-entérologie CHRU de TOURS

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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'
Gedragsmatig: 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).
Geen tussenkomst: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Tijdsspanne: 12 MONTHS
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
12 MONTHS

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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).
Tijdsspanne: 2 MONTHS
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
2 MONTHS
Rate of colorectal cancer.
Tijdsspanne: 12 MONTHS
Rate of colorectal cancer.
12 MONTHS
Rate of advanced adenomas.
Tijdsspanne: 12 MONTHS
Rate of advanced adenomas.
12 MONTHS
Detection rate of scallop lesions.
Tijdsspanne: 12 MONTHS
Detection rate of scallop lesions.
12 MONTHS
Rate of complications in screening colonoscopies.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Tours

Medewerkers

University Hospital, Angers
Poitiers University Hospital
Nantes University Hospital
Centre Hospitalier de Dreux
UNIVERSITY HOSPITAL, ORLEANS
Hospital BLOIS
Hospital LOCHES
Clinic LE MANS

Onderzoekers

  • Hoofdonderzoeker: CAROLI BOSC Françis- Xavier, Pr, University Hospital, Angers
  • Hoofdonderzoeker: MATYSIAK-BUDNIK Tamara, Pr, Chu Nantes
  • Hoofdonderzoeker: LANDAU Alain, Dr, CHG DREUX
  • Hoofdonderzoeker: GARGOT Denis, Dr, CHG BLOIS
  • Hoofdonderzoeker: BARBIEUX Jean- Pierre, Dr, CHG LOCHES
  • Hoofdonderzoeker: TOUGERON David, Pr, CHU Poitiers
  • Hoofdonderzoeker: LEGOUX Jean- Louis, Dr, CHR Orleans
  • Hoofdonderzoeker: BOURGEOIS Hugues, Dr, Clinic Victor Hugo LE MANS

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 april 2017

Primaire voltooiing (Werkelijk)

19 januari 2019

Studie voltooiing (Werkelijk)

19 januari 2019

Studieregistratiedata

Eerst ingediend

28 februari 2017

Eerst ingediend dat voldeed aan de QC-criteria

13 maart 2017

Eerst geplaatst (Werkelijk)

20 maart 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 september 2019

Laatste update ingediend die voldeed aan QC-criteria

25 september 2019

Laatst geverifieerd

1 september 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INCA14-TL/EDUCANCOLAGE
  • 2015-A01514-45 (Andere identificatie: ID RCB)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Kanker Colorectaal

Klinische onderzoeken op Therapeutic Education Strategy

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Moldova

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren