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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)

2019년 9월 25일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

68

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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'
행동: 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).
간섭 없음: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
기간: 12 MONTHS
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
12 MONTHS

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Tours

협력자

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

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 4월 10일

기본 완료 (실제)

2019년 1월 19일

연구 완료 (실제)

2019년 1월 19일

연구 등록 날짜

최초 제출

2017년 2월 28일

QC 기준을 충족하는 최초 제출

2017년 3월 13일

처음 게시됨 (실제)

2017년 3월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 9월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 9월 25일

마지막으로 확인됨

2019년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • INCA14-TL/EDUCANCOLAGE
  • 2015-A01514-45 (기타 식별자: ID RCB)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

암 대장에 대한 임상 시험

Therapeutic Education Strategy에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Kuwait

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다