JMIR Publications

ABSTRACT

Background:

Distress is highly prevalent among cancer patients, but supportive care needs often go unmet. Digital Therapeutics (DTx) hold the potential to overcome barriers in cancer care and improve health outcomes.

Objective:

We conducted a randomized a randomized controlled trial (RCT) to investigate the efficacy of Mika, an app-based DTx to reduce distress across the cancer trajectory.

Methods:

This nationwide wait-list RCT in Germany enrolled cancer patients across all tumor entities diagnosed within the last 5 years. Participants were randomized into intervention (Mika plus usual care (UC)) and control (UC alone) groups. Participants completed online assessments at baseline, 2, 6, and 12 weeks. Primary outcome was change in distress from baseline to week 12 measured by the NCCN Distress Thermometer. Secondary outcomes included depression, anxiety (HADS), fatigue (FACIT-F) and quality of life (QoL, CGI-I). Intention-to-treat (ITT) and per-protocol (PP) analyses were performed. Analyses of covariance were used to test for outcome changes over time between groups, controlling for baseline.

Results:

A total of N = 218 patients (intervention: n = 99, control: n = 119) were included in the ITT analysis. Compared with the control group, the intervention group reported greater reductions in distress (P = .03, ηp² = 0.02), depression (P < .001, ηp² = 0.07), anxiety (P = .03, ηp² = 0.02) and fatigue (P = .04, ηp² = 0.02). PP analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for QoL.

Conclusions:

Mika effectively diminished distress among cancer patients. As a DTx solution, Mika offers accessible, tailored psychosocial and self-management support, addressing unmet needs in cancer care. Clinical Trial: This trial was registered at the German Clinical Trials Register (DRKS00026038).