Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial.
Adolescent
Adult
Aged
Aged, 80 and over
Biliary Tract Surgical Procedures
Carcinoma, Pancreatic Ductal
/ epidemiology
Child
Child, Preschool
Cluster Analysis
Drainage
Enzyme Replacement Therapy
Female
Health Plan Implementation
Humans
Infant
Infant, Newborn
Male
Middle Aged
Multicenter Studies as Topic
Neoadjuvant Therapy
Netherlands
/ epidemiology
Palliative Care
Pancreatic Neoplasms
/ epidemiology
Pancreaticoduodenectomy
Patient Compliance
Quality of Life
Randomized Controlled Trials as Topic
Stents
Treatment Outcome
Young Adult
Best practices
Biliary drainage
Chemotherapy
Implementation
Pancreatic cancer
Pancreatic enzyme replacement therapy
Quality of life
Registry
Stepped-wedge cluster randomized controlled trial
Survival
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
16 Apr 2020
16 Apr 2020
Historique:
received:
22
12
2019
accepted:
18
02
2020
entrez:
18
4
2020
pubmed:
18
4
2020
medline:
8
1
2021
Statut:
epublish
Résumé
Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life.
METHODS/DESIGN
METHODS
PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide.
DISCUSSION
CONCLUSIONS
The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.
Identifiants
pubmed: 32299515
doi: 10.1186/s13063-020-4180-z
pii: 10.1186/s13063-020-4180-z
pmc: PMC7161112
doi:
Banques de données
ClinicalTrials.gov
['NCT03513705']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
334Subventions
Organisme : KWF Kankerbestrijding
ID : UVA2013-5842
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