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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 8
- 主要终点
- Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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.
- •Not applicable
研究组 & 干预措施
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'
干预措施: Therapeutic Education Strategy (Behavioral)
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
结局指标
主要结局
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
时间窗: 12 MONTHS
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
次要结局
- How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.(12 MONTHS)
- Rate of colorectal cancer.(12 MONTHS)
- Rate of advanced adenomas.(12 MONTHS)
- Detection rate of scallop lesions.(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.(12 MONTHS)
- Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.(12 MONTHS)
- Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).(2 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.(12 MONTHS)