Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1):A multicenter stepped-wedge cluster randomized controlled trial
| العنوان: | Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1):A multicenter stepped-wedge cluster randomized controlled trial |
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| المؤلفون: | B.M. Zonderhuis, Tom C.J. Seerden, N. C. M. van Huijgevoort, E. J. M. van Geenen, Leonie J. M. Mekenkamp, Koop Bosscha, C. Wientjes, R. C. Verdonk, Gijs A. Patijn, Rutger Quispel, L.G.M. van der Geest, Lodewijk A.A. Brosens, Frank J. Wessels, M. G. H. van Oijen, O.R.C. Busch, A. Bogte, Johanna W. Wilmink, Emile D. Kerver, Lieke Hol, Tara M. Mackay, J. Verheij, H. Lubbinge, Marjolein Y.V. Homs, I. Q. Molenaar, A.J. ten Tije, B. C. M. Haberkorn, Jennifer M.J. Schreinemakers, V E de Meijer, C.H. van Werkhoven, H.C. van Santvoort, Saskia A C Luelmo, Wouter L. Curvers, C.H.J. van Eijck, F.J. Smits, J. E. van Hooft, F. G. I. van Vilsteren, L. M. J. W. van Driel, F. Wit, Derk Jan A. de Groot, J. T. Haver, Bert A. Bonsing, H. Schut, I.H.J.T. de Hingh, J.W.B. de Groot, N. Haj Mohammad, H.W.M. van Laarhoven, H. Bos, Niels G. Venneman, M. den Dulk, L.B. van Rijssen, Martijn W J Stommel, Sebastiaan Festen, Tessa E H Römkens, Chantal V Hoge, Annelie Vulink, J. de Vos-Geelen, Gjm Hemmink, Marc Jacobs, G.J.M. Creemers, Anouk E J Latenstein, S. van Dieren, Marc G. Besselink, Mike Liem, E. van der Harst, Maartje Los |
| المساهمون: | Surgery, AGEM - Digestive immunity, AGEM - Endocrinology, metabolism and nutrition, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and Quality of Life, APH - Methodology, Oncology, APH - Quality of Care, Ear, Nose and Throat, Graduate School, Pathology, Gastroenterology and Hepatology, CCA -Cancer Center Amsterdam, Gastroenterology and hepatology, CCA - Cancer Treatment and quality of life, Amsterdam Gastroenterology Endocrinology Metabolism, Groningen Institute for Organ Transplantation (GIOT), Center for Liver, Digestive and Metabolic Diseases (CLDM), Guided Treatment in Optimal Selected Cancer Patients (GUTS), Gastroenterology & Hepatology, Medical Oncology, MUMC+: MA Heelkunde (9), RS: NUTRIM - R2 - Liver and digestive health, Interne Geneeskunde, MUMC+: MA Maag Darm Lever (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Medische Oncologie (9) |
| المصدر: | MacKay, T M, Smits, F J, Latenstein, A E J, Bogte, A, Bonsing, B A, Bos, H, Bosscha, K, Brosens, L A A, Hol, L, Busch, O R C, Creemers, G J, Curvers, W L, Den Dulk, M, Van Dieren, S, Van Driel, L M J W, Festen, S, Van Geenen, E J M, Van Der Geest, L G, De Groot, D J A, De Groot, J W B, Haj Mohammad, N, Haberkorn, B C M, Haver, J T, Van Der Harst, E, Hemmink, G J M, De Hingh, I H, Hoge, C, Homs, M Y V, Van Huijgevoort, N C, Jacobs, M A J M, Kerver, E D, Liem, M S L, Los, M, Lubbinge, H, Luelmo, S A C, De Meijer, V E, Mekenkamp, L, Molenaar, I Q, Van Oijen, M G H, Patijn, G A, Quispel, R, Van Rijssen, L B, Römkens, T E H, Van Santvoort, H C, Schreinemakers, J M J, Schut, H, Seerden, T, Stommel, M W J, Ten Tije, A J, Venneman, N G, Verdonk, R C, Verheij, J, Van Vilsteren, F G I, De Vos-Geelen, J, Vulink, A, Wientjes, C, Wit, F, Wessels, F J, Zonderhuis, B, Van Werkhoven, C H, Van Hooft, J E, Van Eijck, C H J, Wilmink, J W, Van Laarhoven, H W M & Besselink, M G 2020, ' Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1) : A multicenter stepped-wedge cluster randomized controlled trial ', Trials, vol. 21, no. 1, 334 . https://doi.org/10.1186/s13063-020-4180-zTest Trials, 21 Trials Trials, 21(1):334. BioMed Central TRIALS, 21(1):334. BMC Trials, 21(1). BMC Trials, 21(1). BioMed Central Ltd. Trials, 21, 1 Trials, Vol 21, Iss 1, Pp 1-18 (2020) Trials, 21(1). BioMed Central Trials, 21(1):334. BioMed Central Ltd |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Male, Survival, Medicine (miscellaneous), GUIDELINES, law.invention, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Study Protocol, 0302 clinical medicine, Superiority Trial, Randomized controlled trial, DESIGN, law, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14], Cluster Analysis, Multicenter Studies as Topic, Pharmacology (medical), 030212 general & internal medicine, Child, Netherlands, Randomized Controlled Trials as Topic, Aged, 80 and over, lcsh:R5-920, Pancreatic enzyme replacement therapy, STATEMENT, Palliative Care, Middle Aged, Neoadjuvant Therapy, Biliary Tract Surgical Procedures, Treatment Outcome, 030220 oncology & carcinogenesis, Child, Preschool, Drainage, Female, Stents, lcsh:Medicine (General), Carcinoma, Pancreatic Ductal, Adult, Quality of life, medicine.medical_specialty, Best practices, Registry, RESECTION, Referral, Adolescent, Best practice, Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0], Biliary drainage, Disease cluster, Pancreaticoduodenectomy, 03 medical and health sciences, Young Adult, Quality of life (healthcare), SDG 3 - Good Health and Well-being, Pancreatic cancer, medicine, Journal Article, Humans, Chemotherapy, Enzyme Replacement Therapy, Stepped-wedge cluster randomized controlled trial, Aged, business.industry, Health Plan Implementation, Infant, Newborn, Infant, Guideline, medicine.disease, Pancreatic Neoplasms, SAMPLE-SIZE, Implementation, Emergency medicine, Patient Compliance, business |
| الوصف: | 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 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 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 ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018. |
| وصف الملف: | application/pdf; text/plain |
| اللغة: | English |
| تدمد: | 1745-6215 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bc579abe0c6c89b5b53855fba26161ceTest https://research.vumc.nl/en/publications/9cf33a71-45a4-4cac-b43f-782103a25fe1Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....bc579abe0c6c89b5b53855fba26161ce |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17456215 |
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