Objective: This waiting-list randomized controlled trial examined the effectiveness of a self-management mHealth app in improving fatigue and quality of life (QoL) in cancer patients and survivors.
Methods: Persons with cancer-related fatigue (CRF) were recruited across four English speaking countries, via social media, and randomized into intervention (n = 519) and control (n = 280) groups. Whereas the intervention group received immediate access to the Untire app, the control group received access only after 12-weeks. Primary outcomes fatigue severity and interference, and secondary outcome QoL were assessed at baseline, 4, 8, and 12-weeks. We ran generalized linear mixed models for all outcomes to determine the effects of app access (yes/no), over 12-weeks, following the intention-to-treat principle.
Results: Compared with the control group, the intervention group showed significantly larger improvements in fatigue severity (d = 0.40), fatigue interference (d = 0.35), and overall QoL on average (d = 0.32) (P's < .01), but not for overall QoL in the past week (P = .07). Sensitivity analyses indicated that participants with medium or high app use benefited most when compared with nonusers and control participants (P's ≤ .02). The intervention effect on fatigue interference was slightly stronger in younger participants (≤56 vs. >56). Effects did not depend on education and cancer status. Reliable change analyses indicated that significantly more people showed full recovery for fatigue in the intervention vs the control group (P's = .02).
Conclusions: The Untire app can be an effective mHealth solution for cancer patients and survivors with moderate to severe CRF.
Keywords: RCT; app; cancer; cancer survivors; fatigue; mHealth; oncology; palliative care; psycho‐oncology; quality of life; self‐management.
© 2020 The Authors. Psycho‐Oncology published by John Wiley & Sons Ltd.