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Carcinoma, Pancreatic DuctalPACAP-1NCT03513705

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

A study testing Best practices in pancreatic cancer care in people with Carcinoma, Pancreatic Ductal, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 17 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Carcinoma, Pancreatic Ductal
What is being tested?
Best practices in pancreatic cancer care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
17 sitesNetherlands
Study dates
22 May 2018to 9 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All pancreatic cancer patients
  • 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

Who cannot join

  • There are no specific exclusion criteria
  • There are no specific center exclusion criteria

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Netherlands17 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Academic Medical Center

    Amsterdam

  • Onze Lieve Vrouwen Gasthuis

    Amsterdam

  • VU Medical Center

    Amsterdam

  • Amphia

    Breda

  • Reinier de Graaf Gasthuis

    Delft

  • Catharina

    Eindhoven

  • Medisch Spectrum Twente

    Enschede

  • University Medical Center Groningen

    Groningen

  • Tjongerschans

    Heerenveen

  • Leiden University Medical Center

    Leiden

  • Maastricht University Medical Center

    Maastricht

  • Radboud University Medical Center

    Nijmegen

  • Erasmus Medical Center

    Rotterdam

  • Maasstad Ziekenhuis

    Rotterdam

  • RAKU (University Medical Center Utrecht and Sint Antonius Ziekenhuis)

    Utrecht

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Best practices in pancreatic cancer care
Keywords
implementation, randomized trial, pancreatic cancer, nationwide, survival, quality of life
Medical subject headings
Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best practices in pancreatic cancer careOther

    All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.

Study groups in NCT03513705
Study groupRoleWhat they receive
Best practiceExperimentalEnhanced implementation of best practices in pancreatic cancer care
Receives: Other: Best practices in pancreatic cancer care
Current practiceNo interventionPancreatic cancer care according to current practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year overall survival

    Overall survival 1-year after diagnosis of pancreatic cancer

    Measured: 1-year

Secondary outcomes (8)

  1. 3-year overall survival

    Overall survival 3-year after diagnosis of pancreatic cancer

    Measured: 3-year

  2. 5-year overall survival

    Overall survival 5-year after diagnosis of pancreatic cancer

    Measured: 5-year

  3. Complications

    Complications of chemotherapy (toxicity grade 3-4 and type of toxicity) and biliary stent placement

    Measured: Through study completion, on average up to 25 months

  4. Effect of implementation of best practices

    Proportion of patients that underwent the separate best practice interventions if applicable

    Measured: Through study completion, on average up to 25 months

  5. Registry outcomes

    Best practice registrations measured through Patient Reported Outcome Measures

    Measured: Through study completion, on average up to 25 months

  6. Registry outcomes

    Best practice registrations measured through the Dutch Pancreatic Cancer Audit

    Measured: Through study completion, on average up to 25 months

  7. Registry outcomes

    Best practice registrations measured through the Netherlands Cancer Registry

    Measured: Through study completion, on average up to 25 months

  8. Use of smartphone application

    Measured: Through study completion, on average up to 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2018
  2. Study start22 May 2018
  3. Primary completion9 Jul 2020
  4. Study completion9 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped-wedge cluster randomized trial
Masking
None (open label)
Enrolment
4,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03513705
Sponsor's protocol ID
W17_454
Other IDs
UVA 2013-5842
Acronym
PACAP-1
Status last verified
Aug 2023
First submitted
12 Apr 2018
Last updated
16 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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)

Publications

  • 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.

    PubMed 39970867

  • 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.

    PubMed 38353966

  • 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.

    PubMed 32299515

Questions about this trial

What is this clinical trial studying?

A study testing Best practices in pancreatic cancer care in people with Carcinoma, Pancreatic Ductal, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 17 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year overall survival (time frame: 1-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03513705, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

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