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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)

25. September 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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'
Verhalten: 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).
Kein Eingriff: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Zeitfenster: 12 MONTHS
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
12 MONTHS

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Tours

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. April 2017

Primärer Abschluss (Tatsächlich)

19. Januar 2019

Studienabschluss (Tatsächlich)

19. Januar 2019

Studienanmeldedaten

Zuerst eingereicht

28. Februar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. März 2017

Zuerst gepostet (Tatsächlich)

20. März 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. September 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. September 2019

Zuletzt verifiziert

1. September 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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