Principal Findings
cancer, toxicities, prostate cancer
CANCER, PROSTATE CANCER
Our data demonstrate the feasibility of an app-based treatment monitoring and ePRO assessment during radiotherapy of HNC. Overall, high compliance rates could be demonstrated among patients, with >80% of patients answering ≥80% of ePRO items each week during the course of their treatment. Despite heterogeneous criteria used to define the feasibility of ePRO monitoring, our findings compare favorably with previous publications on the feasibility of digital surveillance in patients with cancer undergoing radiotherapy. An analysis investigating the feasibility of app-based telemonitoring of patients with prostate cancer undergoing treatment defined a feasibility threshold of 70% of patients answering at least 60% of weekly questions over 3 months [Since patient enrollment in our trial was calculated based on the primary feasibility end point, we cannot dismiss the possibility that, in our data set, the cohort size in the experimental arm was too small to allow the detection of smaller effects regarding patient-related factors that may influence feasibility. Nevertheless, considering the high completion rates, our data suggest that app-based monitoring may provide a feasible approach for monitoring treatment-related symptoms of patients with HNC undergoing radiotherapy.Due to the aggressive surgical approaches, the high radiotherapy doses, and the large treatment fields used in HNC treatment, there is a considerable risk for higher-grade treatment-related toxicities. Therefore, early detection of therapy-associated toxicities and changes in global and disease-specific quality of life is crucial to inform treating physicians and to allow for early interventions. Additionally, daily app-based ePRO surveillance may assure patients of close medical surveillance during radiotherapy. For patient safety reasons, patients in both the experimental and control arms of our trial received regular weekly physician appointments as per institutional standards and additional appointments, if deemed necessary by either the patient or the health care provider, and no additional medical interventions were scheduled based on the information collected through the app. Nevertheless, patients in the ePRO monitoring arm reported a significantly higher symptom burden upon completion of radiotherapy. As patient characteristics were well balanced between both arms of the trial and higher treatment-related toxicities were unlikely in the experimental arm, it is highly probable that daily symptom monitoring sensitized patients to follow up on their own symptoms more closely and lowered the threshold for reporting those symptoms. This is especially conceivable, as both the global health and most domains of generic quality of life ranked similarly between both study arms. However, as no longitudinal daily or weekly monitoring of disease-specific symptom burden was performed in the standard-of-care group during radiotherapy, no meaningful analysis can be carried out to confirm or rule out a sensitization effect.In line with the observed high compliance rates for app-based ePRO monitoring, patient satisfaction was high, and several domains of satisfaction were significantly improved by digital monitoring compared to standard-of-care monitoring. Overall, patient satisfaction values, as assessed by the PSQ-18 questionnaire, were comparable to those observed in other trial data sets [