Journal Article

Digital Therapeutic (Mika) Targeting Distress in Patients With Cancer: Results From a Nationwide Waitlist Randomized Controlled Trial

Lordick, Florian, Esser, Peter, Raue, Jan Simon, Mehnert-Theuerkauf, Anja, Maier, Ayline, Brock, Hannah, Friedrich, Michael, Springer, Franziska, Finke, Gandolf, Montgomery, Guy

2024

Overview

Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes. This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory. This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline. A total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat 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). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life. Mika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care. German Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038.

• Publisher: Journal of Medical Internet Research,Gunther Eysenbach MD MPH, Associate Professor,JMIR Publications
• Subject: Adult / Aged / Analysis of covariance / Anxiety / Cancer / Cancer therapies / Care and treatment / Chronic diseases / Chronic illnesses / Clinical assessment / Clinical outcomes / Clinical research / Clinical trials / Cognitive behavioral therapy / Depression, Mental / Digital health / Efficacy / Exercise / Fatigue / Fatigue - therapy / Female / Functional assessment / German language / Germany / Groups / Health aspects / Health care access / Health services / Health status / Homeopathy / Humans / Informed consent / Intervention / Male / Materia medica and therapeutics / Measuring instruments / Medical diagnosis / Medical treatment / Mental depression / Middle Aged / Mindfulness / Mobile Applications / Neoplasms - complications / Neoplasms - psychology / Neoplasms - therapy / Patient compliance / Patients / Psychological distress / Psychosocial factors / Quality of Life / Questionnaires / Registration / Selfmanagement / Skill development / Smartphones / Social networks / Stress, Psychological - psychology / Stress, Psychological - therapy / Therapeutics / Therapy / Tumors / Waiting Lists