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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 de setembro de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

68

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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'
Comportamental: 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).
Sem intervenção: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Prazo: 12 MONTHS
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
12 MONTHS

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Tours

Colaboradores

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

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de abril de 2017

Conclusão Primária (Real)

19 de janeiro de 2019

Conclusão do estudo (Real)

19 de janeiro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

28 de fevereiro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de março de 2017

Primeira postagem (Real)

20 de março de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de setembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de setembro de 2019

Última verificação

1 de setembro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • INCA14-TL/EDUCANCOLAGE
  • 2015-A01514-45 (Outro identificador: ID RCB)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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