Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT03513705
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2018-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021441', 'term': 'Carcinoma, Pancreatic Ductal'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Stepped-wedge cluster randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-12', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis', 'timeFrame': 'up to 1 year after diagnosis', 'description': 'Quality of life with Area Under the Curve (AUC) up to 1 year after diagnosis'}], 'primaryOutcomes': [{'measure': '1-year overall survival', 'timeFrame': '1-year', 'description': 'Overall survival 1-year after diagnosis of pancreatic cancer'}], 'secondaryOutcomes': [{'measure': '3-year overall survival', 'timeFrame': '3-year', 'description': 'Overall survival 3-year after diagnosis of pancreatic cancer'}, {'measure': '5-year overall survival', 'timeFrame': '5-year', 'description': 'Overall survival 5-year after diagnosis of pancreatic cancer'}, {'measure': 'Complications', 'timeFrame': 'Through study completion, on average up to 25 months', 'description': 'Complications of chemotherapy (toxicity grade 3-4 and type of toxicity) and biliary stent placement'}, {'measure': 'Effect of implementation of best practices', 'timeFrame': 'Through study completion, on average up to 25 months', 'description': 'Proportion of patients that underwent the separate best practice interventions if applicable'}, {'measure': 'Registry outcomes', 'timeFrame': 'Through study completion, on average up to 25 months', 'description': 'Best practice registrations measured through Patient Reported Outcome Measures'}, {'measure': 'Registry outcomes', 'timeFrame': 'Through study completion, on average up to 25 months', 'description': 'Best practice registrations measured through the Dutch Pancreatic Cancer Audit'}, {'measure': 'Registry outcomes', 'timeFrame': 'Through study completion, on average up to 25 months', 'description': 'Best practice registrations measured through the Netherlands Cancer Registry'}, {'measure': 'Use of smartphone application', 'timeFrame': 'Through study completion, on average up to 25 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implementation', 'randomized trial', 'pancreatic cancer', 'nationwide', 'survival', 'quality of life'], 'conditions': ['Carcinoma, Pancreatic Ductal']}, 'referencesModule': {'references': [{'pmid': '39970867', 'type': 'DERIVED', 'citation': 'Seelen LWF, Augustinus S, Stoop TF, Bouwense SAW, Busch OR, Cirkel GA, van Eijck CHJ, de Vos-Geelen J, Groot Koerkamp B, Haj Mohammad N, de Hingh IHJT, van Alphen E, Homs MYV, Liem MSL, Los M, de Meijer VE, Mekenkamp LJM, Sprangers MAG, Stommel MWJ, Wilmink JW, Besselink MG, van Santvoort HC, van Laarhoven HWM, Molenaar IQ; Dutch Pancreatic Cancer Group. Quality of Life Among Patients With Locally Advanced Pancreatic Cancer: A Prospective Nationwide Multicenter Study. J Natl Compr Canc Netw. 2025 Feb 19;23(3):97-104. doi: 10.6004/jnccn.2024.7091.'}, {'pmid': '38353966', 'type': 'DERIVED', 'citation': 'Mackay TM, Latenstein AEJ, Augustinus S, van der Geest LG, Bogte A, Bonsing BA, Cirkel GA, Hol L, Busch OR, den Dulk M, van Driel LMJW, Festen S, de Groot DA, de Groot JB, Groot Koerkamp B, Haj Mohammad N, Haver JT, van der Harst E, de Hingh IH, Homs MYV, Los M, Luelmo SAC, de Meijer VE, Mekenkamp L, Molenaar IQ, Patijn GA, Quispel R, Romkens TEH, van Santvoort HC, Stommel MWJ, Venneman NG, Verdonk RC, van Vilsteren FGI, de Vos-Geelen J, van Werkhoven CH, van Hooft JE, van Eijck CHJ, Wilmink JW, van Laarhoven HWM, Besselink MG; Dutch Pancreatic Cancer Group. Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial. JAMA Surg. 2024 Apr 1;159(4):429-437. doi: 10.1001/jamasurg.2023.7872.'}, {'pmid': '32299515', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Rationale:\n\nThe 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.\n\nObjective:\n\nThe 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.\n\nStudy design:\n\nThe 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.\n\nStudy Population:\n\nProspective cohort of all pancreatic cancer patients diagnosed and treated in the Netherlands.\n\nInterventions:\n\nBest 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.\n\nMain study outcomes:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria patients:\n\n* All pancreatic cancer patients\n\nExclusion Criteria patients:\n\n* There are no specific exclusion criteria\n\nInclusion Criteria clusters:\n\n* 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\n\nExclusion Criteria clusters:\n\n* There are no specific center exclusion criteria'}, 'identificationModule': {'nctId': 'NCT03513705', 'acronym': 'PACAP-1', 'briefTitle': 'Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1)', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): a Multicenter Stepped-wedge Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'W17_454'}, 'secondaryIdInfos': [{'id': 'UVA 2013-5842', 'type': 'OTHER_GRANT', 'domain': "Alpe d'HuZes / Dutch Cancer Society (KWF)"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Best practice', 'description': 'Enhanced implementation of best practices in pancreatic cancer care', 'interventionNames': ['Other: Best practices in pancreatic cancer care']}, {'type': 'NO_INTERVENTION', 'label': 'Current practice', 'description': 'Pancreatic cancer care according to current practice'}], 'interventions': [{'name': 'Best practices in pancreatic cancer care', 'type': 'OTHER', 'description': 'All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.', 'armGroupLabels': ['Best practice']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwen Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Gasthuis', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Heerenveen', 'country': 'Netherlands', 'facility': 'Tjongerschans', 'geoPoint': {'lat': 52.95929, 'lon': 5.91854}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'RAKU (University Medical Center Utrecht and Sint Antonius Ziekenhuis)', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Marc Besselink, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Medical Center - Cancer Center Amsterdam'}]}, 'ipdSharingStatementModule': {'url': 'http://www.dpcg.nl', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Upon request', 'ipdSharing': 'YES', '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)', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Cancer Society', 'class': 'OTHER'}, {'name': 'Comprehensive Cancer Centre The Netherlands', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'M.G. Besselink', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}