JMIR Publications

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. We showed good feasibility and high acceptability of SOFIA in routine clinical care.

Objective:

This pilot study aimed to evaluate the use of SOFIA. We applied a mixed-methods design, combining a qualitative exploration of patients’ perspectives 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 semi-structured interviews at two time points during the 12-week intervention period: midway through the intervention (at week 6) (T1) and post-intervention (T2). Qualitative data were analysed with content analysis. User data were deceptively analysed with Python and the Pandas library (version 2.2.3).

Results:

Our qualitative analysis of n = 29 patients revealed benefits regarding the ePRO assessment (empowerment, support, user-friendliness, facilitation of the physician-patient-communication) as well as criticism (inflexible design, insufficient use by physicians). Benefits of the coaching tool include the availability of helpful information and design aspects like clarity and user friendliness. Quantitative data show that 50% of patients read articles, 87% started journeys and 47% did exercises in any period of the study.

Conclusions:

The results of this mixed-methods study may provide important indications for digital interventions, including ePRO assessment, for patients with cancer. Intuitive design, relevant symptom items, reliable reminder functions, the translation of patient-reported data into clinically actionable information, clear symptom visualizations and seamless integration into electronic health records as well as the clinician engagement and integration seem to be important from the patients’ perspective. Both our qualitative and quantitative data show the importance of therapy-specific contents. These results might increase the acceptance and usage, and thereby also the clinical benefit of future digital interventions for patients with cancer. Clinical Trial: The study was registered in the German Clinical Trial Register (reference: DRKS00021064).