BACKGROUND Multidisciplinary treatment for head and neck carcinoma offers the best curative results but generates acute toxicities, which negatively affect both patients' quality of life and treatment compliance. Usually, the patient's clinical condition is recorded during scheduled, time-limited office visits and patients might forget to discuss symptoms occurred weeks before. They could also have difficulties contacting their clinicians outside of these limited encounters. Technology-based interventions for oncological patients have already been proved to encourage accurate symptoms report through regular inquiries of their clinical conditions. OBJECTIVES The aim of this work is to present the results of a pilot study about the assessment of a novel mobile application for reporting clinical parameters, quality of life, and symptoms of home patients affected by head and neck carcinoma, during chemo-radiotherapy and the subsequent follow-up period. Results will inform app designers about the necessary modifications to face a full-scale trial. METHODS Ten patients used the app for the foreseen period (up to 65 days, median 50.5), at the end of which they answered a paper questionnaire addressing user satisfaction with the app. The questionnaire included 8 questions and a free text comment field. Patients were followed by three clinicians, who also answered a similar paper questionnaire at the end of the pilot study. Questionnaires total score ranged 0-25 and a threshold of 16 was set in the study protocol to represent an overall positive outcome. However, to consider the individual constructs, questions about usability, perceived usefulness and user acceptance were also analyzed separately, and association among them was investigated. Finally, the feasibility of the intervention was analyzed in terms of the actual use of the app, i.e. dropout rates and compliance with the required data input. Statistics were only performed on patients' data, due to the small number of doctors involved in the study. RESULTS The median of the total score per patient was 18.5 (interquartile range 11.2-20.5), and per doctor was 16 (range 11-20), thus showing a positive overall satisfaction with the app. Concerning patients, only 4 out of a total of 80 answers (10 patients × 8 questions) expressed a definite negative feeling. Perceived usefulness was a critical issue for some patients. It was positively correlated with usability, and both aspects were independent predictors of acceptance. Feasibility was demonstrated by the low percentage of dropouts (9%) and noncompliance with assignments (10%). A significant (p = 0.007) negative correlation between the severity of reported symptoms and the EuroQoL questionnaire scores was found, supporting the consistency of the entered data. Free comments were reported by 6 Patients. CONCLUSIONS This study was meant to explore the context of outpatients' remote monitoring through the collection of patient-reported outcomes. The intervention for a proactive approach to symptoms monitoring in curatively treated head and neck cancer patients resulted feasible and acceptable by both patients and oncologists. The study revealed a criticality on the perceived usefulness, but, at the same time, the patients' comments suggested how to improve this aspect. Further actions will need to focus on measuring the impact of HeNeA on the process of care and on the health outcomes.

中文翻译：

---

基于智能手机的监控干预对同时接受化学放疗的头颈癌患者的一项初步研究。

背景技术头颈癌的多学科治疗提供最佳的疗效，但产生急性毒性，这对患者的生活质量和治疗依从性均产生负面影响。通常，在计划的限时办公室就诊期间记录患者的临床状况，患者可能忘记讨论几周前出现的症状。在这些有限的遭遇之外，他们也可能难以联系临床医生。已经证明，基于技术的针对肿瘤患者的干预措施可以通过定期查询其临床状况来鼓励准确的症状报告。目标这项工作的目的是提出一项关于评估新型移动应用程序以评估临床参数，生活质量，在化学放疗期间和随后的随访期间，受头颈癌影响的家庭患者的症状和体征。结果将通知应用程序设计师有关进行全面测试所需的修改。方法在可预见的时间段（最长65天，中位数50.5）中，有10位患者使用了该应用程序，最后他们回答了一份纸质问卷，说明用户对该应用程序的满意度。问卷包括8个问题和一个自由文本评论字段。在三位临床医生的陪同下对患者进行了随访，他们在初步研究结束时也回答了类似的纸质问卷。问卷总分在0-25之间，研究方案中设定的门槛为16，代表总体阳性结果。但是，要考虑各个结构，有关可用性的问题，还分别分析了感知的有用性和用户接受度，并调查了它们之间的关联。最后，根据应用程序的实际使用情况（即辍学率和对所需数据输入的依从性）分析了干预的可行性。由于参与研究的医生人数少，因此仅根据患者数据进行统计。结果每位患者的总得分中位数为18.5（四分位数范围为11.2-20.5），每位医生的总得分中位数为16（范围为11-20），因此对该应用程序的总体满意度很高。关于患者，在总共80个答案（10个患者×8个问题）中，只有4个表达出肯定的负面感觉。对某些患者来说，有用的感知是一个关键问题。它与可用性呈正相关，并且这两个方面都是接受度的独立预测因素。辍学率低（9％）和不遵守作业（10％）证明了可行性。发现所报告症状的严重程度与EuroQoL问卷得分之间存在显着的（p = 0.007）负相关，支持所输入数据的一致性。6位患者报告了免费评论。结论本研究旨在通过收集患者报告的结果来探索门诊病人远程监控的背景。积极治疗头颈癌患者的症状监测方法的干预措施是可行的，并且被患者和肿瘤学家接受。该研究揭示了在感知到的有用性方面的关键性，但与此同时，患者的 评论提出了如何改善这方面的建议。需要采取进一步行动，着重于衡量HeNeA对护理过程和健康结果的影响。