Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): a Multicenter Stepped-wedge Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,000
- 试验地点
- 17
- 主要终点
- 1-year overall survival
研究概览
简要总结
PACAP-1 will evaluate to what extent an enhanced implementation of best practices in pancreatic cancer care leads to a prolonged survival and improvement of quality of life as compared to current practice.
详细描述
Rationale:
The Dutch Pancreatic Cancer Project (PACAP) is an initiative of the Dutch Pancreatic Cancer Group and was officially launched in July 2014. PACAP is 1 of the largest nationwide collaborative outcomes registration and biobanking projects on pancreatic and periampullary cancer worldwide and includes the Dutch Pancreatic Cancer Audit (DPCA), the Patient Reported Outcome Measures (PROMs), an online expert panel, and the Netherlands Cancer Registry (NCR, Netherlands Comprehensive Cancer Organization; IKNL). During the first 3 years of PACAP, regional variations in treatment and guideline (non-)compliance were observed. These differences may lead to differences in survival and quality of life of pancreatic cancer patients throughout the Netherlands. From PACAP data and literature, best practices for pancreatic cancer care have been identified.
Objective:
The aim of PACAP-1 is to evaluate to what extent an enhanced implementation of best practices in pancreatic cancer care in the Netherlands leads to a prolonged survival and improvement of quality of life as compared to current practice.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pancreatic cancer patients
排除标准
- •There are no specific exclusion criteria
- •Inclusion Criteria clusters:
- •All 17 centers of the DPCG. These centers each perform >20 pancreatoduodenectomies (PDs) annually. Each center already has a coordinating role for pancreatic cancer for its region. It is expected that the enhanced implementation of best practices will have an impact in the entire local network
- •Exclusion Criteria clusters:
- •There are no specific center exclusion criteria
研究组 & 干预措施
Best practice
Enhanced implementation of best practices in pancreatic cancer care
干预措施: Best practices in pancreatic cancer care (Other)
Current practice
Pancreatic cancer care according to current practice
结局指标
主要结局
1-year overall survival
时间窗: 1-year
Overall survival 1-year after diagnosis of pancreatic cancer
次要结局
- Use of smartphone application(Through study completion, on average up to 25 months)
- Registry outcomes(Through study completion, on average up to 25 months)
- Effect of implementation of best practices(Through study completion, on average up to 25 months)
- 5-year overall survival(5-year)
- Complications(Through study completion, on average up to 25 months)
- 3-year overall survival(3-year)
研究者
M.G. Besselink
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)