2022-RA-1467-ESGO Digital health-related app support of patients with gynaecological malignancies: results of a pilot study

Abstract

Introduction/Background Cancer diagnosis and treatment are linked to an increased risk of severe emotional distress, fatigue and mental comorbidity, such as depression. Given that access to psycho‐oncological care is limited, evaluating the effectiveness of widely accessible digital psycho‐oncology is paramount. Here, we performed a randomised, intra‐individually controlled pilot study to examine the preliminary effectiveness and feasibility of the cancer app 'Mika'. Methodology A total of N = 70 participants with gynaecological cancer (ovarian, cervical,and endometrial) receiving either postoperative care (n = 35) or routine outpatient chemotherapy (n = 35) were recruited via convenience sampling and randomly assigned to intervention (n = 50) (IG) and waitinglist control groups (n = 20) (CG). Primary outcome depression levels and secondary outcomes fatigue symptoms, health literacy, adherence, dropout‐rate, and reasons for drop‐out were assessed at baseline, 4, 8, and 12 weeks. Intraindividual effects of the app were measured from baseline to week 12. Results The IG showed significant reductions in depressive symptoms by 42% (d = 0.85) and fatigue by 23.1% (d = 0.5). Participants in the IG undergoing chemotherapy even showed a reduction in fatigue by 31% (d = 0.8). The dropout rate was 37.1% (26/70) (IG: 8/20, 40%; CG: 18/50, 36%). Primary reasons for dropouts were death (n = 10) and health status deterioration (n = 11). Conclusion The pilot study provides preliminary evidence of the effectiveness, feasibility, and acceptability of the Mika app in improving the psychological well‐being in patients with gynaecological malignancies. A full‐scale trial will allow a comprehensive evaluation of the effectiveness of the psycho‐oncological mHealth intervention Mika relative to a CG.