Clinical trial NCT03513705: Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1)
Official title: Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): a Multicenter Stepped-wedge Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Pancreatic Ductal
Keywords: implementation
randomized trial
pancreatic cancer
nationwide
survival
quality of life
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Comprehensive Cancer Centre The Netherlands
First posted: 2018-05-01
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria patients:

* All pancreatic cancer patients

Exclusion Criteria patients:

* There are no specific exclusion criteria

Inclusion Criteria clusters:

* 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

Exclusion Criteria clusters:

* There are no specific center exclusion criteria

Primary outcomes:
measure: 1-year overall survival
timeFrame: 1-year
Secondary outcomes:
measure: 3-year overall survival
timeFrame: 3-year
measure: 5-year overall survival
timeFrame: 5-year
measure: Complications
timeFrame: Through study completion, on average up to 25 months
measure: Effect of implementation of best practices
timeFrame: Through study completion, on average up to 25 months
measure: Registry outcomes
timeFrame: Through study completion, on average up to 25 months
measure: Registry outcomes
timeFrame: Through study completion, on average up to 25 months
measure: Registry outcomes
timeFrame: Through study completion, on average up to 25 months
measure: Use of smartphone application
timeFrame: Through study completion, on average up to 25 months
Other outcomes:
measure: Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis
timeFrame: up to 1 year after diagnosis
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Breda
country: Netherlands
facility: Amphia
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Heerenveen
country: Netherlands
facility: Tjongerschans
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Utrecht
country: Netherlands
facility: RAKU (University Medical Center Utrecht and Sint Antonius Ziekenhuis)
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Academic Medical Center - Cancer Center Amsterdam
name: Marc Besselink, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.