A pilot study of a smartphone-based monitoring intervention on head and neck cancer patients undergoing concurrent chemo-radiotherapy

Background: Multidisciplinary treatment for head and neck carcinoma offers the best curative results but generates acute toxicities, which negatively affect both patients\u2019 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\u201325 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\u2019 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\u201320.5), and per doctor was 16 (range 11\u201320), thus showing a positive overall satisfaction with the app. Concerning patients, only 4 out of a total of 80 answers (10 patients 7 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\u2019 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\u2019 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