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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Pancreatic Ductal
• Intervention / Treatment: Other: Best practices in pancreatic cancer care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tara Mackay, MD; Phone Number: 0031205661904; Email: pacap-1@dpcg.nl
• Study Contact Backup: Name: Anouk Latenstein, MD; Phone Number: 0031205661904; Email: pacap-1@dpcg.nl

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Comprehensive Cancer Centre The Netherlands; Dutch Cancer Society
• Investigators: Principal Investigator: Marc Besselink, Prof. Dr., Academic Medical Center - Cancer Center Amsterdam

Publications and helpful links

General Publications

• Mackay TM, Smits FJ, Latenstein AEJ, Bogte A, Bonsing BA, Bos H, Bosscha K, Brosens LAA, Hol L, Busch ORC, Creemers GJ, Curvers WL, den Dulk M, van Dieren S, van Driel LMJW, Festen S, van Geenen EJM, van der Geest LG, de Groot DJA, de Groot JWB, Haj Mohammad N, Haberkorn BCM, Haver JT, van der Harst E, Hemmink GJM, de Hingh IH, Hoge C, Homs MYV, van Huijgevoort NC, Jacobs MAJM, Kerver ED, Liem MSL, Los M, Lubbinge H, Luelmo SAC, de Meijer VE, Mekenkamp L, Molenaar IQ, van Oijen MGH, Patijn GA, Quispel R, van Rijssen LB, Romkens TEH, van Santvoort HC, Schreinemakers JMJ, Schut H, Seerden T, Stommel MWJ, Ten Tije AJ, Venneman NG, Verdonk RC, Verheij J, van Vilsteren FGI, de Vos-Geelen J, Vulink A, Wientjes C, Wit F, Wessels FJ, Zonderhuis B, van Werkhoven CH, van Hooft JE, van Eijck CHJ, Wilmink JW, van Laarhoven HWM, Besselink MG; Dutch Pancreatic Cancer Group. Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial. Trials. 2020 Apr 16;21(1):334. doi: 10.1186/s13063-020-4180-z.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): July 9, 2020
• Study Completion (Actual): July 9, 2021

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; randomized trial; survival; pancreatic cancer; implementation; nationwide
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Pancreatic Neoplasms; Carcinoma, Pancreatic Ductal
• Other Study ID Numbers: W17_454; UVA 2013-5842 (Other Grant/Funding Number: Alpe d'HuZes / Dutch Cancer Society (KWF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data generated during the PACAP-1 trial will be made available to other researcher upon request from Marc Besselink and/or the Dutch Pancreatic Cancer Group (DPCG)
• IPD Sharing Time Frame: Upon request
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No