EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST, A RANDOMISED CONTROLLED TRIAL. (SUIVICOLO)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Colonoscopy rate at 6 months after a positive test
研究概览
简要总结
To be effective, organized colorectal cancer screening requires good adherence to diagnostic colonoscopy in the event of a positive test. In France, the rate of diagnostic colonoscopy following a positive colorectal cancer screening test is less than 85%, and the median delay is close to 90 days. After receiving their positive result from the laboratory, individuals with no known follow-up are contacted only six months later by the Regional Cancer Screening Coordination Centers (CRCDC) responsible for following up with individuals who have tested positive. To optimize follow-up with colonoscopy, earlier contact and information about colonoscopy appear to be necessary. The contribution of the general practitioner identified on the test could be an additional lever.
The SUIVICOLO study aims to evaluate the effectiveness on the rate of colonoscopies performed at 6 months of two strategies for optimizing the follow-up of positive results in comparison with control group C (current procedures of the CRCDC Centre Val de Loire without early letter).
The two strategies evaluated will be:
- Group B1: Sending an early letter signed by the CRCDC accompanied by information leaflet about colonoscopy
- Group B2: Sending an early letter co-signed by the CRCDC and the general practitioner (identified or provided by the patient on the test identification form) accompanied by information leaflet about colonoscopy.
These strategies will be compared to the current follow-up strategy in a three arm randomized controlled arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 50 and 75 at the time of the positive colorectal cancer screening test
- •Residing in one of the departments of the Centre Val de Loire region
- •Date on which the positive CRC screening test result was sent to the beneficiary recorded
- •Colorectal cancer screening test results sent to the beneficiary within 30 days of the test being read
- •Affiliated with a health insurance fund
排除标准
- •Subjects who have notified their refusal to allow their data to be used for research purposes will be excluded from the analyses.
研究组 & 干预措施
Control group (usual care)
干预措施: Usual care follow-up by CRCDC (Other)
Early letter with information leaflet about colonoscopy
B1
干预措施: Usual care follow-up by CRCDC (Other)
Early letter with information leaflet about colonoscopy
B1
干预措施: Information leaflet about colonoscopy follow-up (Other)
Early letter endorsed by the GP with information leaflet about colonoscopy
B2
干预措施: Information leaflet about colonoscopy follow-up (Other)
Early letter endorsed by the GP with information leaflet about colonoscopy
B2
干预措施: Endorsement of CRCDC letters from the GP (Other)
Early letter endorsed by the GP with information leaflet about colonoscopy
B2
干预措施: Usual care follow-up by CRCDC (Other)
结局指标
主要结局
Colonoscopy rate at 6 months after a positive test
时间窗: 6 months
次要结局
- Number of people with a CT colonography(24 months)
- Time to perform colonoscopy(24 months)
- Colorectal cancer at colonoscopy(24 months)
- Advanced neoplasia at colonoscopy(24 months)
- Number of people who refused colonoscopy(24 months)
- Number of lost to follow-up(24 months)
- Percentage of general practitioners who agreed to participate in the project(At baseline)
- Colonoscopy rates at 12 months after a positive test(12 months)
- Colonoscopy rates at 18 months after a positive test(18 months)
- Colonoscopy rates at 24 months after a positive test(24 months)
- Number of reminders in each group by type of reminder(24 months)
- Number of people with contraindications to colonoscopy(24 months)