Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1)

Study Overview
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Brief Summary
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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.

Detailed Description
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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: The PACAP-1 trial is a nationwide stepped-wedge cluster randomized controlled trial. In a per center stepwise and randomized manner, best practices in pancreatic cancer care are implemented in all 17 Dutch pancreatic centers. A regional pancreatic cancer team will be established per pancreatic center that functions as point of contact for peripheral centers in the region. Patient outcomes and compliance will be monitored by the registries founded in the PACAP initiative. Study Population: Prospective cohort of all pancreatic cancer patients diagnosed and treated in the Netherlands. Interventions: Best practices will be implemented in 3 key medical specialties in pancreatic cancer care: medical oncology, surgery and gastroenterology. Best practices will be implemented in centers during a 6 week intensive initiation period which includes monitoring, return visits, provider feedback in combination with education and reminders. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature and can be executed without additional overall costs per center. Main study outcomes: The primary outcome is 1-year overall survival. Secondary outcomes include quality of life (first secondary outcome), 3- and 5-year overall survival and success of implementation of every PACAP-1 intervention and participation in DPCG randomized trials.

Official Title
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Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): a Multicenter Stepped-wedge Cluster Randomized Controlled Trial

Conditions
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Carcinoma, Pancreatic Ductal

Intervention / Treatment
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* Other: Best practices in pancreatic cancer care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria patients: All pancreatic cancer patients Exclusion Criteria patients: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped-wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Best practice<br>Enhanced implementation of best practices in pancreatic cancer care | Other: Best practices in pancreatic cancer care<br>* All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.<br>|
| No Intervention: Current practice<br>Pancreatic cancer care according to current practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year overall survival | Overall survival 1-year after diagnosis of pancreatic cancer | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival | Overall survival 3-year after diagnosis of pancreatic cancer | 3-year | 
| 5-year overall survival | Overall survival 5-year after diagnosis of pancreatic cancer | 5-year | 
| Complications | Complications of chemotherapy (toxicity grade 3-4 and type of toxicity) and biliary stent placement | Through study completion, on average up to 25 months | 
| Effect of implementation of best practices | Proportion of patients that underwent the separate best practice interventions if applicable | Through study completion, on average up to 25 months | 
| Registry outcomes | Best practice registrations measured through Patient Reported Outcome Measures | Through study completion, on average up to 25 months | 
| Registry outcomes | Best practice registrations measured through the Dutch Pancreatic Cancer Audit | Through study completion, on average up to 25 months | 
| Registry outcomes | Best practice registrations measured through the Netherlands Cancer Registry | Through study completion, on average up to 25 months | 
| Use of smartphone application |  | Through study completion, on average up to 25 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation, randomized trial, pancreatic cancer, nationwide, survival, quality of life