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Trial record 11 of 2874 for:    Pancreatic Cancer

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
Sponsor:
Collaborators:
Dutch Cancer Society
Comprehensive Cancer Centre The Netherlands
Information provided by (Responsible Party):
M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Other: Best practices in pancreatic cancer care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2142 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped-wedge cluster randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 1-year overall survival [ Time Frame: 1-year ]
    Overall survival 1-year after diagnosis of pancreatic cancer


Secondary Outcome Measures :
  1. 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

  2. 3-year overall survival [ Time Frame: 3-year ]
    Overall survival 3-year after diagnosis of pancreatic cancer

  3. 5-year overall survival [ Time Frame: 5-year ]
    Overall survival 5-year after diagnosis of pancreatic cancer

  4. 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

  5. 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

  6. Registry outcomes [ Time Frame: Through study completion, on average up to 25 months ]
    Best practice registrations measured through Patient Reported Outcome Measures

  7. Registry outcomes [ Time Frame: Through study completion, on average up to 25 months ]
    Best practice registrations measured through the Dutch Pancreatic Cancer Audit

  8. Registry outcomes [ Time Frame: Through study completion, on average up to 25 months ]
    Best practice registrations measured through the Netherlands Cancer Registry

  9. Use of smartphone application [ Time Frame: Through study completion, on average up to 25 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Tara Mackay, MD 0031205661904 pacap-1@dpcg.nl
Contact: Anouk Latenstein, MD 0031205661904 pacap-1@dpcg.nl

Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: Marc Besselink         
Onze Lieve Vrouwen Gasthuis Recruiting
Amsterdam, Netherlands
Contact: Sebastiaan Festen         
VU Medical Center Recruiting
Amsterdam, Netherlands
Contact: Geert Kazemier         
Amphia Recruiting
Breda, Netherlands
Contact: Albert-Jan Ten Tije         
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands
Contact: Annelie Vulink         
Jeroen Bosch Ziekenhuis Recruiting
Den Bosch, Netherlands
Contact: Koop Bosscha         
Catharina Recruiting
Eindhoven, Netherlands
Contact: Ignace de Hingh         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
Contact: Mike Liem         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Vincent de Meijer         
Tjongerschans Recruiting
Heerenveen, Netherlands
Contact: Fennie Wit         
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Bert Bonsing         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Judith de Vos         
Radboud University Medical Center Recruiting
Nijmegen, Netherlands
Contact: Martijn Stommel         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Marjolein Homs         
Maasstad Ziekenhuis Recruiting
Rotterdam, Netherlands
Contact: Lieke Brouwer-Hol         
RAKU (University Medical Center Utrecht and Sint Antonius Ziekenhuis) Recruiting
Utrecht, Netherlands
Contact: Hjalmar van Santvoort         
Contact: Quintus Molenaar         
Isala Klinieken Recruiting
Zwolle, Netherlands
Contact: Gijs Patijn         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Cancer Society
Comprehensive Cancer Centre The Netherlands
Investigators
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Principal Investigator: Marc Besselink, Prof. Dr. Academic Medical Center - Cancer Center Amsterdam

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Responsible Party: M.G. Besselink, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03513705     History of Changes
Other Study ID Numbers: W17_454
UVA 2013-5842 ( Other Grant/Funding Number: Alpe d'HuZes / Dutch Cancer Society (KWF) )
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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)
Supporting Materials: Study Protocol
Time Frame: Upon request
Access Criteria: Upon request
URL: http://www.dpcg.nl

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
implementation
randomized trial
pancreatic cancer
nationwide
survival
quality of life
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Digestive System Diseases
Endocrine System Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma