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

Carcinoma, Pancreatic Ductal Clinical Trial

— PACAP-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513705
• Other study ID #: W17_454
• Secondary ID: UVA 2013-5842
• Status: Completed
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: July 9, 2021

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Pancreatic Neoplasms

Intervention

Other:
• Best practices in pancreatic cancer care
All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam
Netherlands	VU Medical Center	Amsterdam
Netherlands	Amphia	Breda
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	Catharina	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Tjongerschans	Heerenveen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Maasstad Ziekenhuis	Rotterdam
Netherlands	RAKU (University Medical Center Utrecht and Sint Antonius Ziekenhuis)	Utrecht
Netherlands	Isala Klinieken	Zwolle

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Comprehensive Cancer Centre The Netherlands, Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis	Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis	up to 1 year after diagnosis
Primary	1-year overall survival	Overall survival 1-year after diagnosis of pancreatic cancer	1-year
Secondary	3-year overall survival	Overall survival 3-year after diagnosis of pancreatic cancer	3-year
Secondary	5-year overall survival	Overall survival 5-year after diagnosis of pancreatic cancer	5-year
Secondary	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
Secondary	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
Secondary	Registry outcomes	Best practice registrations measured through Patient Reported Outcome Measures	Through study completion, on average up to 25 months
Secondary	Registry outcomes	Best practice registrations measured through the Dutch Pancreatic Cancer Audit	Through study completion, on average up to 25 months
Secondary	Registry outcomes	Best practice registrations measured through the Netherlands Cancer Registry	Through study completion, on average up to 25 months
Secondary	Use of smartphone application		Through study completion, on average up to 25 months