Digital Intervention for Electronic Patient-Reported Outcomes in Advanced Cancer: Mixed Methods Study.

Background: Digital health interventions are increasingly being integrated into oncological care to support patients in managing treatment-related symptoms and psychological distress. In a randomized controlled pilot trial, we investigated the feasibility and preliminary efficacy of a digital health app (SOFIA) among patients with cancer, including those in palliative care. SOFIA consists of an electronic patient-reported outcome (ePRO) assessment and coaching component. We showed good feasibility and high acceptability of SOFIA in routine clinical care. Objective: This pilot study aimed to evaluate user experiences and behavior with SOFIA. We applied a mixed methods design, combining a qualitative exploration of patients' experiences and a quantitative analysis of app usage patterns. The integrated findings are intended to inform the refinement and further development of digital health interventions to better address the needs, preferences, and engagement behaviors of this patient population. Methods: Patients randomly assigned to the intervention group participated in semistructured interviews at 2 time points during the 12-week intervention period: midway through the intervention (at week 6) (T1) and postintervention (at week 12) (T2). Qualitative data were analyzed using content analysis. User data were descriptively analyzed with Python and the Pandas library (version 2.2.3). Results: Our qualitative analysis of 29 patients revealed benefits regarding the ePRO assessment (empowerment, support, user-friendliness, and facilitation of patient-physician communication), as well as some criticism (inflexible design and insufficient use by physicians). Benefits of the coaching tool included the availability of helpful information and design aspects such as clarity and user-friendliness. Quantitative data from 32 active users of the app showed that 16 (50%) of patients read articles, 28 (87.5%) started journeys, and 15 (46.9%) completed exercises at any point during the study. Conclusions: The results of this mixed methods study may provide important indications for digital interventions, including ePRO assessment, for patients with cancer. From the patients' perspective, key features include intuitive design, relevant symptom items, reliable reminder functions, the translation of ePROs into clinically actionable information, clear symptom visualizations, seamless integration into electronic health records, and effective physician engagement. Both our qualitative and quantitative data show the importance of therapy-specific content. These results might increase acceptance and usage, and thereby also the clinical benefit, of future digital interventions for patients with cancer.