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

Conditions

Carcinoma, Pancreatic Ductal

Keywords

implementation, randomized trial, pancreatic cancer, nationwide, survival, quality of life

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.

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.

Leonard W. F. Seelen, Simone Augustinus, Thomas F. Stoop, Stefan A.W. Bouwense, Olivier R. Busch et al. (25 authors)

Journal of the National Comprehensive Cancer Network2025-02-191 citations

10.6004/jnccn.2024.7091

Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4): study protocol.

Stoop TF, Seelen LWF, van 't Land FR, van der Hout AC, Scheepens JCM, Ali M, Stiggelbout AM, van der Kolk BM, Bonsing BA, Lips DJ, de Groot DJA, van Veldhuisen E, Kerver ED, Manusama ER, Daams F, Kazemier G, Cirkel GA, van Tienhoven G, Patijn GA, Lelieveld-Rier HN, de Hingh IH, van Hellemond IEG, Wijsman JH, Erdmann JI, Mieog JSD, de Vos-Geelen J, de Groot JWB, Lutchman KRD, Mekenkamp LJ, Kranenburg LW, Beuk LPM, Nijkamp MW, den Dulk M, Polée MB, Homs MYV, Wumkes ML, Stommel MWJ, Busch OR, de Wilde RF, Theijse RT, Luelmo SAC, Festen S, Bollen TL, Neumann UP, de Meijer VE, Draaisma WA, Groot Koerkamp B, Molenaar IQ, Wolfgang CL, Del Chiaro M, Katz MGH, Hackert T, Rietjens JAC, Wilmink JW, van Santvoort HC, van Eijck CHJ, Besselink MG, Dutch Pancreatic Cancer Group.

2025-02-191 citations

10.1186/s12885-025-13554-w

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands

Tara M. Mackay, Anouk E.J. Latenstein, Simone Augustinus, Lydia G. van der Geest, Auke Bogte et al. (66 authors)

JAMA Surgery2024-02-1419 citations

10.1001/jamasurg.2023.7872

Nationwide implementation of best practices in pancreatic cancer care (PACAP-1): Stepped-wedge cluster randomized trial.

Tara M. Mackay, Anouk E.J. Latenstein, Simone Augustinus, Lydia G. van der Geest, Auke Bogte et al. (21 authors)

Journal of Clinical Oncology2023-06-01

10.1200/jco.2023.41.16_suppl.4152

Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial.

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, Römkens 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.

2020-04-1616 citations

10.1186/s13063-020-4180-z

Establishing and Coordinating a Nationwide Multidisciplinary Study Group: Lessons Learned by the Dutch Pancreatic Cancer Group

Marin Strijker, Tara M. Mackay, Bert A. Bonsing, Marco J. Bruno, Casper H.J. van Eijck et al. (15 authors)

Annals of Surgery2020-02-2173 citations

10.1097/sla.0000000000003779

Interventions

OTHERBest practices in pancreatic cancer care

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Stepped-wedge cluster randomized trial

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

patients: * All pancreatic cancer patients

Exclusion criteria

patients: * There are no specific

Design outcomes

Primary

Measure	Time frame	Description
1-year overall survival	1-year	Overall survival 1-year after diagnosis of pancreatic cancer

Secondary

Measure	Time frame	Description
3-year overall survival	3-year	Overall survival 3-year after diagnosis of pancreatic cancer
5-year overall survival	5-year	Overall survival 5-year after diagnosis of pancreatic cancer
Complications	Through study completion, on average up to 25 months	Complications of chemotherapy (toxicity grade 3-4 and type of toxicity) and biliary stent placement
Registry outcomes	Through study completion, on average up to 25 months	Best practice registrations measured through Patient Reported Outcome Measures
Use of smartphone application	Through study completion, on average up to 25 months	—
Effect of implementation of best practices	Through study completion, on average up to 25 months	Proportion of patients that underwent the separate best practice interventions if applicable

Other

Measure	Time frame	Description
Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis	up to 1 year after diagnosis	Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis

Countries

Netherlands

Outcome results

None listed