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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Date
2024-09
Journal Title
Journal ISSN
Volume Title
Publisher
Medip Academy
Abstract
Background: 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.
Description
Keywords
Decentralized clinical trials, Home nursing, Clinical research, Oncology
Citation
Stabile 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): 162-169