Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1) (PACAP-1)
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|ClinicalTrials.gov Identifier: NCT03513705|
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Pancreatic Ductal||Other: Best practices in pancreatic cancer care||Not Applicable|
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.
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.
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.
Prospective cohort of all pancreatic cancer patients diagnosed and treated in the Netherlands.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2142 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Stepped-wedge cluster randomized trial|
|Masking:||None (Open Label)|
|Official Title:||Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): a Multicenter Stepped-wedge Cluster Randomized Controlled Trial|
|Actual Study Start Date :||May 22, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2025|
Experimental: Best practice
Enhanced implementation of best practices in pancreatic cancer care
Other: Best practices in pancreatic cancer care
All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.
No Intervention: Current practice
Pancreatic cancer care according to current practice
- 1-year overall survival [ Time Frame: 1-year ]Overall survival 1-year after diagnosis of pancreatic cancer
- Quality of life [ Time Frame: up to 1 year after diagnosis ]Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis
- 3-year overall survival [ Time Frame: 3-year ]Overall survival 3-year after diagnosis of pancreatic cancer
- 5-year overall survival [ Time Frame: 5-year ]Overall survival 5-year after diagnosis of pancreatic cancer
- Complications [ Time Frame: Through study completion, on average up to 25 months ]Complications of chemotherapy (toxicity grade 3-4 and type of toxicity) and biliary stent placement
- Effect of implementation of best practices [ Time Frame: Through study completion, on average up to 25 months ]Proportion of patients that underwent the separate best practice interventions if applicable
- Registry outcomes [ Time Frame: Through study completion, on average up to 25 months ]Best practice registrations measured through Patient Reported Outcome Measures
- Registry outcomes [ Time Frame: Through study completion, on average up to 25 months ]Best practice registrations measured through the Dutch Pancreatic Cancer Audit
- Registry outcomes [ Time Frame: Through study completion, on average up to 25 months ]Best practice registrations measured through the Netherlands Cancer Registry
- Use of smartphone application [ Time Frame: Through study completion, on average up to 25 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513705
|Contact: Tara Mackay, MDfirstname.lastname@example.org|
|Contact: Anouk Latenstein, MDemail@example.com|
|Principal Investigator:||Marc Besselink, Prof. Dr.||Academic Medical Center - Cancer Center Amsterdam|