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

Stefano Stabile; Veronica Franchina; Sara Testoni; Francesca Mannozzi; Francesca Fabbri; Irene Federici; Marta Betti; Francesca Zepponi; Angela Frazzetto; Giovanni Micallo; Raffaella Bertolotti; Claudia Sangalli; Celeste Cagnazzo; Oriana Nanni

doi:10.18203/2349-3259.ijct20241997

Authors

Stefano Stabile SC Oncologia Falck, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy
Veronica Franchina U.O.C. Oncologia Medica A.O. Papardo, Messina
Sara Testoni Unità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Francesca Mannozzi Unità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Francesca Fabbri Unità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Irene Federici Clinica di Ematologia, AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Ancona, Italy
Marta Betti Dipartimento Attività Integrate Ricerca Innovazione, AO SS. Antonio e Biagio e Cesare Arrigo, Alessandria
Francesca Zepponi SOD Oncologia Clinica, Azienda Ospedaliero-Universitaria Careggi, Firenze
Angela Frazzetto Farmacia Clinica, Fondazione Policlinico Tor Vergata, Roma
Giovanni Micallo Dipartimento di Ricerca e Assistenziale di OncoEmatologia, Neoplasie Mesenchimali e Muscolo Scheletriche dell'Adulto e Diagnostica Innovativa Istituto Nazionale Tumori - Fondazione “G. Pascale”, Napoli
Raffaella Bertolotti Data Management, Clinical Trial Office, European Institute of Oncology IRCCS, Milan, Italy
Claudia Sangalli Data Management, Clinical Trial Office, European Institute of Oncology IRCCS, Milan, Italy
Celeste Cagnazzo Dipartimento Patologia e Cura del Bambino, Regina Margherita AOU Città della Salute e della Scienza di Torino, Presidio Infantile Regina Margherita, Turin, Italy
Oriana Nanni Unità di Biostatistica e Sperimentazioni Cliniche, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy

DOI:

https://doi.org/10.18203/2349-3259.ijct20241997

Keywords:

Decentralized clinical trials, Home nursing, Clinical research, Oncology

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.

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