Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy.
Unit of Biostatistic and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy.
BMJ Open. 2022 Jan 11;12(1):e055814. doi: 10.1136/bmjopen-2021-055814.
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.
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.
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.
Version 2, 6 April 2021.
NCT04826458.
ONCO-TreC 平台由一个移动应用程序组成，通过电子日记的形式提供给患者，同时还有一个基于网络的仪表盘，由医疗保健专业人员管理。我们旨在比较 ONCO-TreC 电子日记和标准纸质日记在提高实体瘤和血液系统肿瘤患者口服癌症治疗依从性方面的效果。
这是一项在意大利两个肿瘤学单位进行的开放标签、优效性、随机对照试验。患者将按照 1:1 的比例随机分配到电子日记或纸质日记组。两组都将由一名顾问负责药物和日记的发放。评估期将在六个治疗周期后结束。主要目的是比较两组中不依从的患者比例。依从性将通过药物计数进行测量；任何服用的药物剂量少于规定总剂量的 90%的患者都将被视为不依从。假设 B 组中口服治疗的不依从率为 40%，A 组中这一比例降低 60%，则需要 124 名患者入组，才能使用双侧 Fisher 精确检验，以 0.05 的显著性水平，识别出大于 24 个百分点的绝对差异，具有 80%的效能。考虑到 10%的脱落率，大约需要招募 136 名患者。主要分析将在意向治疗人群中进行。次要目标是描述不依从的原因、患者和医疗保健专业人员对纸质和电子日记的满意度，以及不依从在医疗成本方面的影响。
伦罗曼尼亚伦理委员会（CEROM）已批准该研究，研究 ID 为 2108，2020 年 4 月 10 日批准号 IRST 100.28。所有研究参与者都将获得知情同意。研究结果将通过同行评议期刊、会议和活动报告进行传播。
第 2 版，2021 年 4 月 6 日。
NCT04826458。
