Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1)
NCT ID: NCT03513705
Last Updated: 2023-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4000 participants
INTERVENTIONAL
2018-05-22
2021-07-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Best practice
Enhanced implementation of best practices in pancreatic cancer care
Best practices in pancreatic cancer care
All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.
Current practice
Pancreatic cancer care according to current practice
No interventions assigned to this group
Interventions
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Best practices in pancreatic cancer care
All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Comprehensive Cancer Centre The Netherlands
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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M.G. Besselink
Prof. Dr.
Principal Investigators
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Marc Besselink, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Center - Cancer Center Amsterdam
Locations
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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
Countries
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References
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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.
Mackay 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.
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.
Other Identifiers
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UVA 2013-5842
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
W17_454
Identifier Type: -
Identifier Source: org_study_id
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