Trials (Apr 2020)
Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial
- T. M. Mackay,
- F. J. Smits,
- A. E. J. Latenstein,
- A. Bogte,
- B. A. Bonsing,
- H. Bos,
- K. Bosscha,
- L. A. A. Brosens,
- L. Hol,
- O. R. C. Busch,
- G. J. Creemers,
- W. L. Curvers,
- M. den Dulk,
- S. van Dieren,
- L. M. J. W. van Driel,
- S. Festen,
- E. J. M. van Geenen,
- L. G. van der Geest,
- D. J. A. de Groot,
- J. W. B. de Groot,
- N. Haj Mohammad,
- B. C. M. Haberkorn,
- J. T. Haver,
- E. van der Harst,
- G. J. M. Hemmink,
- I. H. de Hingh,
- C. Hoge,
- M. Y. V. Homs,
- N. C. van Huijgevoort,
- M. A. J. M. Jacobs,
- E. D. Kerver,
- M. S. L. Liem,
- M. Los,
- H. Lubbinge,
- S. A. C. Luelmo,
- V. E. de Meijer,
- L. Mekenkamp,
- I. Q. Molenaar,
- M. G. H. van Oijen,
- G. A. Patijn,
- R. Quispel,
- L. B. van Rijssen,
- T. E. H. Römkens,
- H. C. van Santvoort,
- J. M. J. Schreinemakers,
- H. Schut,
- T. Seerden,
- M. W. J. Stommel,
- A. J. ten Tije,
- N. G. Venneman,
- R. C. Verdonk,
- J. Verheij,
- F. G. I. van Vilsteren,
- J. de Vos-Geelen,
- A. Vulink,
- C. Wientjes,
- F. Wit,
- F. J. Wessels,
- B. Zonderhuis,
- C. H. van Werkhoven,
- J. E. van Hooft,
- C. H. J. van Eijck,
- J. W. Wilmink,
- H. W. M. van Laarhoven,
- M. G. Besselink,
- for the Dutch Pancreatic Cancer Group
Affiliations
- T. M. Mackay
- Department of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- F. J. Smits
- Department of surgery, University Medical Center Utrecht
- A. E. J. Latenstein
- Department of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- A. Bogte
- Department of gastroenterology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital
- B. A. Bonsing
- Department of surgery, Leiden University Medical Center
- H. Bos
- Department of medical oncology, Tjongerschans Hospital
- K. Bosscha
- Department of surgery, Jeroen Bosch Hospital
- L. A. A. Brosens
- Department of pathology, University Medical Center Utrecht
- L. Hol
- Department of gastroenterology, Maasstad Hospital
- O. R. C. Busch
- Department of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- G. J. Creemers
- Department of medical oncology, Catharina Hospital
- W. L. Curvers
- Department of gastroenterology, Catharina Hospital
- M. den Dulk
- Department of surgery, Maastricht UMC+
- S. van Dieren
- Department of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- L. M. J. W. van Driel
- Department of gastroenterology, Erasmus Medical Center
- S. Festen
- Department of surgery, OLVG
- E. J. M. van Geenen
- Department of gastroenterology, Radboud UMC
- L. G. van der Geest
- Department of Research, Netherlands Comprehensive Cancer Organisation (IKNL)
- D. J. A. de Groot
- Department of medical oncology, University Medical Center Groningen
- J. W. B. de Groot
- Department of medical oncology, Oncology Center Isala
- N. Haj Mohammad
- Department of Medical Oncology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital
- B. C. M. Haberkorn
- Department of medical oncology, Maasstad Hospital
- J. T. Haver
- Department of nutrition and dietetics, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- E. van der Harst
- Department of surgery, Maasstad Hospital
- G. J. M. Hemmink
- Department of gastroenterology, Oncology Center Isala
- I. H. de Hingh
- Department of surgery, Catharina Hospital
- C. Hoge
- Department of gastroenterology, Maastricht UMC+
- M. Y. V. Homs
- Department of medical oncology, Erasmus Medical Center
- N. C. van Huijgevoort
- Department of gastroenterology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- M. A. J. M. Jacobs
- Department of gastroenterology, Cancer Center Amsterdam, Amsterdam UMC, VU Medical Center
- E. D. Kerver
- Department of medical oncology, OLVG
- M. S. L. Liem
- Department of surgery, Medisch Spectrum Twente
- M. Los
- Department of Medical Oncology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital
- H. Lubbinge
- Department of gastroenterology, Tjongerschans Hospital
- S. A. C. Luelmo
- Department of medical oncology, Leiden University Medical Center
- V. E. de Meijer
- Department of surgery, University Medical Center Groningen
- L. Mekenkamp
- Department of medical oncology, Medisch Spectrum Twente
- I. Q. Molenaar
- Department of surgery, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital
- M. G. H. van Oijen
- Department of medical oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- G. A. Patijn
- Department of surgery, Oncology Center Isala
- R. Quispel
- Department of gastroenterology, Reinier de Graaf Hospital
- L. B. van Rijssen
- Department of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- T. E. H. Römkens
- Department of gastroenterology, Jeroen Bosch Hospital
- H. C. van Santvoort
- Department of surgery, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital
- J. M. J. Schreinemakers
- Department of surgery, Amphia Hospital
- H. Schut
- Department of medical oncology, Jeroen Bosch Hospital
- T. Seerden
- Department of gastroenterology, Amphia Hospital
- M. W. J. Stommel
- Department of surgery, Radboud UMC
- A. J. ten Tije
- Department of medical oncology, Amphia Hospital
- N. G. Venneman
- Department of gastroenterology and hepatology, Medisch Spectrum Twente
- R. C. Verdonk
- Department of gastroenterology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital
- J. Verheij
- Department of pathology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- F. G. I. van Vilsteren
- Department of gastroenterology, University Medical Center Groningen
- J. de Vos-Geelen
- Department of medical oncology, Maastricht UMC+
- A. Vulink
- Department of medical oncology, Reinier de Graaf Hospital
- C. Wientjes
- Department of gastroenterology, OLVG
- F. Wit
- Department of surgery, Tjongerschans Hospital
- F. J. Wessels
- Department of radiology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital
- B. Zonderhuis
- Department of surgery, Cancer Center Amsterdam, Amsterdam UMC, VU Medical Center
- C. H. van Werkhoven
- Julius Center for Health Sciences and primary care, University Medical Center Utrecht, Utrecht University
- J. E. van Hooft
- Department of gastroenterology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- C. H. J. van Eijck
- Department of surgery, Erasmus Medical Center
- J. W. Wilmink
- Department of medical oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- H. W. M. van Laarhoven
- Department of medical oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- M. G. Besselink
- Department of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
- for the Dutch Pancreatic Cancer Group
- DOI
- https://doi.org/10.1186/s13063-020-4180-z
- Journal volume & issue
-
Vol. 21,
no. 1
pp. 1 – 18
Abstract
Abstract Background Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. Methods/design PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. Discussion The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. Trial registration ClinicalTrials.gov, NCT03513705 . Trial opened for accrual on 22th May 2018.
Keywords
- Pancreatic cancer
- Survival
- Quality of life
- Stepped-wedge cluster randomized controlled trial
- Implementation
- Best practices
