Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial.

Autor:	Passardi A; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Serra P; Unit of Biostatistic and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Caffo O; Department of Medical Oncology, Provincia autonoma di Trento Azienda Provinciale per i Servizi Sanitari, Trento, Italy., Masini C; Oncology Pharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Brugugnoli E; Oncology Pharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Vespignani R; IT Service, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy roberto.vespignani@irst.emr.it., Giardino V; Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Petracci E; Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Bartolini G; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Sullo F; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Anesi C; Department of Medical Oncology, Provincia autonoma di Trento Azienda Provinciale per i Servizi Sanitari, Trento, Italy., Dianti M; eHealth Unit, Bruno Kessler Foundation, Trento, Italy., Eccher C; eHealth Unit, Bruno Kessler Foundation, Trento, Italy., Piras EM; eHealth Unit, Bruno Kessler Foundation, Trento, Italy., Gios L; Competence Center for Digital Health, TrentinoSalute 4.0, Trento, Italy., Campomori A; Hospital Pharmacy Unit, Presidio Ospedaliero Santa Chiara, Trento, Italy., Oberosler V; Hospital Pharmacy Unit, Presidio Ospedaliero Santa Chiara, Trento, Italy., Forti S; eHealth Unit, Bruno Kessler Foundation, Trento, Italy.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Jan 11; Vol. 12 (1), pp. e055814. Date of Electronic Publication: 2022 Jan 11.
DOI:	10.1136/bmjopen-2021-055814
Abstrakt:	Introduction: ONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours. Methods and Analysis: This is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher's exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs. Ethics and Dissemination: Ethical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. Protocol Version: Version 2, 6 April 2021. Trial Registration Number: NCT04826458. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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