Efficacy of a cognitive-behavioral digital therapeutic on psychosocial outcomes in cancer patients: A randomized controlled trial

In this randomized controlled trial, we investigated the efficacy of the digital cognitive behavioral therapy-based program <i>lancivis</i> in improving quality of life (QoL), cancer-related fatigue, distress symptoms and fear of cancer progression in <i>N</i> = 604 cancer patients and survivors in Germany. Participants in the intervention group (IG; <i>n</i> = 304) used <i>lancivis</i> alongside treatment as usual (TAU) while participants in the control group (CG; <i>n</i> = 300) received TAU only. Intent-to-treat (ITT) analyses revealed significant improvements in fatigue in the IG compared to the CG after 3 months (T1; Cohen's <i>d</i>: 0.29) and 6 months (T2; Cohen's <i>d</i>: 0.31). Participants in the IG reported also significantly lower fear of cancer progression than the CG at T1 and T2 and lower levels of distress symptoms at T2. No between group differences were found for health-related QoL. Results suggest that <i>lancivis</i> may present a beneficial addition to psycho-oncological care services.