Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Feb 2, 2023
Date Accepted: Jul 24, 2023
App-controlled treatment monitoring and support for head and neck cancer patients undergoing radiotherapy: results from a prospective randomized controlled trial
ABSTRACT
Background:
Head-and-neck cancers (HNCs) are very common malignancies, and treatment often requires multimodality approaches including radiotherapy and chemotherapy. HNC patients often display a high symptom burden, both due to disease itself and the required multimodal therapy. Close telemonitoring of symptoms and quality-of-life during the course of treatment may help to identify those HNC patients requiring early medical support.
Objective:
The App-Controlled Treatment Monitoring and Support for Head-and-Neck Cancer Patients (APCOT) trial aimed to investigate the feasibility of integrating electronic patient-reported outcome (ePROs) in the treatment surveillance pathway of HNC patients during the course of their radiotherapy. Additionally, the influence of app-based ePRO monitoring on global and disease-specific quality-of-life and patient satisfaction with treatment was assessed.
Methods:
Patients undergoing radiotherapy for histologically proven HNCs at the Department of Radiation Oncology, University Medical Center Freiburg, Germany, were enrolled in this trial and monitored by weekly physician appointments. Patients were randomized between additional ePRO monitoring on each treatment day or standard-of-care. Feasibility of ePRO monitoring was defined for ≥80% of enrolled patients answering ≥80% of their daily app-based questions. Quality-of-life and patient satisfaction were assessed by the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire and H&N35 module and the validated Patient Satisfaction Questionnaire Short Form (PSQ-18) at the completion of treatment and compared between trial arms.
Results:
100 patients were enrolled in this trial, and 93 patients were evaluable. All patients in the experimental arm (100%) answered ≥80% of ePRO questions during treatment, reaching the pre-defined threshold for feasibility of ePRO monitoring (p<0.001, binomial test). No clinical or patient-specific factor was found to influence feasibility. Global health and most domains of general quality-of-life were comparable between trial arms, but an increased head-and-neck cancer-specific symptom burden was reported by patients undergoing ePRO surveillance. Improved patient satisfaction parameters interpersonal manner (p=0.01), financial aspects (p=0.01) and time spent with doctor (p=0.01) were reported in patients in whom ePROs were monitored.
Conclusions:
This trial demonstrated the feasibility of integrating daily app-based ePRO surveillance in head-and-neck cancer patients undergoing radiotherapy. Telemonitoring in this setting increased reporting of head-and-neck cancer-specific symptom burden and significantly improved several domains of patient satisfaction. Further analyses are needed to assess whether our findings hold true outside the context of a clinical trial. Clinical Trial: German Clinical Trials Register (DRKS00020491)
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