Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
研究概览
详细说明
Regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (CRC) in patients at increased familial CRC risk. Currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. In 2008, a national multidisciplinary evidence-based guideline on familial and hereditary CRC was launched in the Netherlands. Clinicians have new tasks in familial CRC risk calculation, interpretation and communication. A clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen Dutch hospitals to determine the most cost effective way to implement these new guidelines.
Surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. Patients and clinicians in the intervention group will receive an additional intervention strategy.
The effect evaluation is done by assessing the number of CRC patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. The actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. The costs of the implementation procedure will be determined by means of a cost evaluation.
研究类型
注册 (预期的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical diagnosis of colorectal cancer before the age of 70
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Exclusion Criteria:
- Previous referral for genetic counseling
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:控制
|
Dissemination of guidelines
|
|
实验性的:Implementation aids
|
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
大体时间:1 year
|
1 year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
The number of patients for whom MSI testing was performed based on the MIPA criteria
大体时间:1 year
|
1 year
|
|
The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)
大体时间:1 year
|
1 year
|
|
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
大体时间:1 year
|
1 year
|
|
The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians
大体时间:1 year
|
1 year
|
|
Patients' uptake of the follow up policy
大体时间:1 year
|
1 year
|
|
Actual exposure to the different elements of the implementation strategy
大体时间:1 year
|
1 year
|
|
Experiences of clinicians and patients with the different elements of the implementation strategy
大体时间:1 year
|
1 year
|
|
Costs of the implementation procedure
大体时间:1 year
|
1 year
|
合作者和调查者
合作者
调查人员
- 首席研究员:Nicoline Hoogerbrugge, MD, PhD、Radboud University Medical Center
- 首席研究员:Rosella PMG Hermens, PhD、Radboud University Medical Center
出版物和有用的链接
一般刊物
- Dekker N, Hermens RP, Nagengast FM, van Zelst-Stams WA, Hoogerbrugge N; RISCO study group. Familial colorectal cancer risk assessment needs improvement for more effective cancer prevention in relatives. Colorectal Dis. 2013 Apr;15(4):e175-85; discussion p.e185. doi: 10.1111/codi.12117.
- Dekker N, Hermens RP, Elwyn G, van der Weijden T, Nagengast FM, van Duijvendijk P, Salemink S, Adang E, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Improving calculation, interpretation and communication of familial colorectal cancer risk: protocol for a randomized controlled trial. Implement Sci. 2010 Jan 28;5:6. doi: 10.1186/1748-5908-5-6.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- ZonMw 80-82315-98-09005
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.