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. Issue 1 (11th January 2022)

• Record Type: Journal Article
• Authors: Passardi, Alessandro; Serra, Patrizia; Caffo, Orazio; Masini, Carla; Brugugnoli, Erika; Vespignani, Roberto; Giardino, Valeria; Petracci, Elisabetta; Bartolini, Giulia; Sullo, Francesco; Anesi, Cecilia; Dianti, Marco; Eccher, Claudio; Piras, Enrico Maria; Gios, Lorenzo; Campomori, Annalisa; Oberosler, Valentina; Forti, Stefano
• Is Part Of: BMJ open. Volume 12:Issue 1(2022)
• Publication Date: 2022-01-11
• Subjects: information management -- oncology -- oral medicine; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-055814
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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 .