Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1)
PACAP-1
2 other identifiers
interventional
4,000
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
May 1, 2018
CompletedStudy Start
First participant enrolled
May 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2021
CompletedAugust 16, 2023
August 1, 2023
2.1 years
April 12, 2018
August 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-year overall survival
Overall survival 1-year after diagnosis of pancreatic cancer
1-year
Secondary Outcomes (8)
3-year overall survival
3-year
5-year overall survival
5-year
Complications
Through study completion, on average up to 25 months
Effect of implementation of best practices
Through study completion, on average up to 25 months
Registry outcomes
Through study completion, on average up to 25 months
- +3 more secondary outcomes
Other Outcomes (1)
Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis
up to 1 year after diagnosis
Study Arms (2)
Best practice
EXPERIMENTALEnhanced implementation of best practices in pancreatic cancer care
Current practice
NO INTERVENTIONPancreatic cancer care according to current practice
Interventions
All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.
Eligibility Criteria
You may qualify if:
- All pancreatic cancer patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 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
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, Netherlands
Related Publications (3)
Seelen LWF, Augustinus S, Stoop TF, Bouwense SAW, Busch OR, Cirkel GA, van Eijck CHJ, de Vos-Geelen J, Groot Koerkamp B, Haj Mohammad N, de Hingh IHJT, van Alphen E, Homs MYV, Liem MSL, Los M, de Meijer VE, Mekenkamp LJM, Sprangers MAG, Stommel MWJ, Wilmink JW, Besselink MG, van Santvoort HC, van Laarhoven HWM, Molenaar IQ; Dutch Pancreatic Cancer Group. Quality of Life Among Patients With Locally Advanced Pancreatic Cancer: A Prospective Nationwide Multicenter Study. J Natl Compr Canc Netw. 2025 Feb 19;23(3):97-104. doi: 10.6004/jnccn.2024.7091.
PMID: 39970867DERIVEDMackay TM, Latenstein AEJ, Augustinus S, van der Geest LG, Bogte A, Bonsing BA, Cirkel GA, Hol L, Busch OR, den Dulk M, van Driel LMJW, Festen S, de Groot DA, de Groot JB, Groot Koerkamp B, Haj Mohammad N, Haver JT, van der Harst E, de Hingh IH, Homs MYV, Los M, Luelmo SAC, de Meijer VE, Mekenkamp L, Molenaar IQ, Patijn GA, Quispel R, Romkens TEH, van Santvoort HC, Stommel MWJ, Venneman NG, Verdonk RC, van Vilsteren FGI, de Vos-Geelen J, van Werkhoven CH, van Hooft JE, van Eijck CHJ, Wilmink JW, van Laarhoven HWM, Besselink MG; Dutch Pancreatic Cancer Group. Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial. JAMA Surg. 2024 Apr 1;159(4):429-437. doi: 10.1001/jamasurg.2023.7872.
PMID: 38353966DERIVEDMackay 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.
PMID: 32299515DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Besselink, Prof. Dr.
Academic Medical Center - Cancer Center Amsterdam
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
April 12, 2018
First Posted
May 1, 2018
Study Start
May 22, 2018
Primary Completion
July 9, 2020
Study Completion
July 9, 2021
Last Updated
August 16, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Upon request
- Access Criteria
- Upon request
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)