1861P - A randomized controlled trial on the efficacy and safety of the Untire app for moderate-to-severe cancer-related fatigue in German patients

Background

This RCT examined the clinical efficacy and safety of the German version of the self-management Untire app for reducing fatigue and improving quality of life in cancer patients and survivors, with the hypothesis that app access as an add-on to care as usual will lead to superior clinical outcomes in patients with moderate-to-severe fatigue as compared to care as usual only, over 12-weeks.

Methods

Patients with cancer-related fatigue (CRF) were recruited from across Germany through newspaper advertisements, and randomized (1:1) to receive either care-as-usual alone (control; n=111) or care-as-usual plus access to the Untire app (intervention; n=104). The primary outcome measure was fatigue, and secondary outcomes included quality of life, stress, depression, and anxiety, all assessed at baseline, 4, 8, and 12 weeks. Linear mixed models, ANCOVAs were employed for all outcomes to evaluate the treatment effects over 12 weeks while adjusting for baseline values and adhering to the intention-to-treat principle.

Results

The intervention group experienced a significantly larger improvement at week 12, with an average fatigue score of 4.8 (SE=0.18) compared to 5.6 (SE=0.17) in the control group (p=0.0016, 95% CI: -1.29 to -0.30). This difference of -0.79 is statistically significant and also clinically relevant as it is larger than the MCID of -0.57, with 58.7% of patients in the intervention group experiencing an improvement of more than 0.57 points compared to 43.2% in the control group. For the secondary outcomes, disease-related quality-of-life scores were also significantly higher in the intervention group at week 12 (p=0.0178, 95% CI: 0.16 to 1.64), and improved to a clinically relevant degree. No significant interactions were found between the treatment groups and the subgroup variables. Sensitivity analyses (per-protocol and reference-based) indicated the robustness of the findings. The degree of app usage did not affect the treatment effect over 12 weeks. Adverse events occurred with no discernible patterns between groups, and no deaths occurred during the trial.

Conclusions

The German version of Untire can be an effective and safe digital health application for patients with moderate to severe CRF.

Clinical trial identification

DRKS00027477.

Editorial acknowledgement

Tired of Cancer B.V. - Dr. Simon Spahrkäs - Dr. Fatemeh Akbari - Dr. Bram Kuiper THINC University Medical Center Utrecht. - Katharina Abrahams - Prof. Dr. Hans Reitsma - Prof. Dr. Ewoud Schuit CRO Zenner - Prof. Dr. H.P. Zenner GmbH.

Legal entity responsible for the study

CRO Zenner GmbH, and THINC University Medical center Utrecht.

Funding

Tired of Cancer B.V.

Disclosure

S. Spahrkäs, F. Akbari, B. Kuiper: Other, Institutional, Full or part-time Employment: Tired of Cancer B.V.. K. Abraham, H. Reitsma, E. Schuit: Other, Institutional, Full or part-time Employment: THINC. H-P. Zenner: Other, Institutional, Full or part-time Employment: CRO Zenner.