Perception of decentralized clinical trials and home nursing in oncology clinical research: insights from a survey of clinical research professionals across experimental sites

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dc.contributor.authorStabile, Sen_US
dc.contributor.authorFranchina, Ven_US
dc.contributor.authorTestoni, Sen_US
dc.contributor.authorMannozzi, Fen_US
dc.contributor.authorFabbri, Fen_US
dc.contributor.authorFederici, Ien_US
dc.contributor.authorBetti, Men_US
dc.contributor.authorZepponi, Fen_US
dc.contributor.authorFrazzetto, Aen_US
dc.contributor.authorMicallo, Gen_US
dc.contributor.authorBertolotti, Ren_US
dc.contributor.authorSangalli, Cen_US
dc.contributor.authorCagnazzo, Cen_US
dc.contributor.authorNanni, O.en_US
dc.date.accessioned2025-05-09T08:46:55Z
dc.date.available2025-05-09T08:46:55Z
dc.date.issued2024-09
dc.description.abstractBackground: Post-COVID-19, rapid technological progress enabled remote healthcare interactions, fostering DCT activities. Sponsors and sites adapted by digitizing traditional model, utilizing wearables and home nursing. However, challenges like staff oversight and logistics demand careful evaluation for regulatory compliance. Methods: Italian association of medical oncology's study coordinators working group, in collaboration with Italian group of data managers, conducted an anonymous online survey among Italian oncology professionals. Survey aimed to explore their perceptions of remote patient monitoring, trial activities, and home nursing in oncology clinical trials. Results: Out of 111 professionals (42.3% coordinators, 27.0% physicians, 18.8% nurses), 29.7% lacked prior experience in remote patient data capture, while 61.3% had low or medium experience. On a 0-10 VAS scale, 58.6% found remote modalities very useful, with high scores (8-10) for various remote activities like quality of life data capture (71.2%), vital signs transmission (66.7%), and home nursing tasks (65.8%). Regarding home nursing in oncology clinical trials 73.0% of participants (n=81) have declared no previous experience. However this remote activity is considered highly useful for tasks such as biological samples collection (76.6%), vital signs collection (73.9%), quality of life evaluation (71.2%), and adverse events monitoring (65.8%). Conclusions: Electronic devices for remote data capture are prevalent in oncology trials, positively perceived by a significant portion of staff. Remote data collection correlates with improved workload perception. Although home nursing is less common in Italy, healthcare professionals show a positive perception, indicating potential benefits for clinical trial efficiency and workload improvement.en_US
dc.identifier.affiliationsSC Oncologia Falck, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italyen_US
dc.identifier.affiliationsU.O.C. Oncologia Medica A.O. Papardo, Messinaen_US
dc.identifier.affiliationsUnità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italyen_US
dc.identifier.affiliationsUnità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italyen_US
dc.identifier.affiliationsUnità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italyen_US
dc.identifier.affiliationsClinica di Ematologia, AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Ancona, Italyen_US
dc.identifier.affiliationsDipartimento Attività Integrate Ricerca Innovazione, AO SS. Antonio e Biagio e Cesare Arrigo, Alessandriaen_US
dc.identifier.affiliationsSOD Oncologia Clinica, Azienda Ospedaliero-Universitaria Careggi, Firenzeen_US
dc.identifier.affiliationsFarmacia Clinica, Fondazione Policlinico Tor Vergata, Romaen_US
dc.identifier.affiliationsDipartimento di Ricerca e Assistenziale di OncoEmatologia, Neoplasie Mesenchimali e Muscolo Scheletriche dell'Adulto e Diagnostica Innovativa Istituto Nazionale Tumori - Fondazione “G. Pascale”, Napolien_US
dc.identifier.affiliationsData Management, Clinical Trial Office, European Institute of Oncology IRCCS, Milan, Italyen_US
dc.identifier.affiliationsData Management, Clinical Trial Office, European Institute of Oncology IRCCS, Milan, Italyen_US
dc.identifier.affiliationsDipartimento Patologia e Cura del Bambino, Regina Margherita AOU Città della Salute e della Scienza di Torino, Presidio Infantile Regina Margherita, Turin, Italyen_US
dc.identifier.affiliationsUnità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italyen_US
dc.identifier.citationStabile S, Franchina V, Testoni S, Mannozzi F, Fabbri F, Federici I, Betti M, Zepponi F, Frazzetto A, Micallo G, Bertolotti R, Sangalli C, Cagnazzo C, Nanni O.. Perception of decentralized clinical trials and home nursing in oncology clinical research: insights from a survey of clinical research professionals across experimental sites . International Journal of Clinical Trials. 2024 Sep; 11(3): 162-169en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/243644
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber3en_US
dc.relation.volume11en_US
dc.source.urihttps://doi.org/10.18203/2349-3259.ijct20241997en_US
dc.subjectDecentralized clinical trialsen_US
dc.subjectHome nursingen_US
dc.subjectClinical researchen_US
dc.subjectOncologyen_US
dc.titlePerception of decentralized clinical trials and home nursing in oncology clinical research: insights from a survey of clinical research professionals across experimental sitesen_US
dc.typeJournal Articleen_US
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