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

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: Not applicable — no comparative efficacy analysis performed; descriptive engagement proportions only

• Primary Outcome: User experience of the SOFIA digital health app among patients with advanced cancer: qualitative themes included empowerment, support for patient-physician communication, user-friendliness, inflexible design, and insufficient physician engagement with ePRO data

• Nnt Or Sensitivity: Not applicable; engagement metrics reported as proportions: 50% (16/32) read articles, 87.5% (28/32) started journeys, 46.9% (15/32) completed exercises at any point during the 12-week study

• Confidence Interval: Not reported

Clinical Application

The study demonstrates that a digital ePRO and coaching app is acceptable and usable for a majority of patients with advanced cancer willing to engage. However, engagement is heterogeneous (exercise completion only 46.9%), and physician-side integration remains a critical unresolved barrier. Implementation requires investment in clinician training, EHR integration, and workflow redesign — resources that vary substantially across healthcare settings. SOFIA is a German-developed app and is not currently listed on the TGA's Australian Register of Therapeutic Goods (ARTG) as a regulated software as a medical device (SaMD). Australian oncology practice increasingly incorporates ePRO tools — the RACGP and Cancer Australia have highlighted patient-reported outcomes as a priority in cancer survivorship and palliative care frameworks. Comparable Australian platforms (e.g., those integrated with My Health Record) would need to demonstrate similar feasibility and, critically, efficacy data before PBS-subsidised or MBS-supported implementation could be considered. The findings regarding physician non-engagement with ePRO data are particularly relevant to Australian primary care and oncology settings, where GP-specialist communication gaps in cancer care are well-documented. Rural and remote access, digital literacy disparities, and CALD population needs would require specific consideration in any Australian adaptation. Adult patients with advanced or palliative cancer who are digitally literate and receiving care at specialist oncology centres with infrastructure to integrate ePRO data into clinical workflows

Abstract

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.

References

1. 1.Sauer, C., Sauer, S., Doll, E. S., Zschäbitz, S., Raue, J. S., Turni, M., Bugaj, T. J., Hiller, K., & Maatouk, I. (2026). Digital intervention for electronic patient-reported outcomes in advanced cancer: Mixed methods study. JMIR Cancer. https://doi.org/10.2196/91416