Multicenter randomized trial of electronic patient-reported outcome monitoring with alert-based interventions in metastatic breast cancer

Electronic patient-reported outome (PRO) monitoringhas shown benefits in advanced cancer, but data specific to metastatic breast cancer (mBC) are limited. Fatigue is a common, clinically important, and functionally impairing symptom in mBC, making it a patient-centered target for electronic PRO monitoring. A randomized trial at 52 centers in Germany investigated whether digital PRO monitoring with alert-based responses reduces fatigue in 909 adult patients with mBC (median age 50 years; range 19-83). The intervention group completed weekly PRO questionnaires via a smartphone using validated short forms. Automated alerts based on predefined PRO deterioration were emailed to traine local nurses or physicians, who contacted patients by telephone within 48 hours. The control group received usual care with quarterly PRO questionnaires and no alerts. The primary outcome was fatigue at 6 months. Baseline mean fatigue scores were 57.6 (SD 9.5) in the intervention group and 60.0 (9.0) in the control group. At 6 months adjusted mean fatigue scores were 54.5 (95% CI 53.7-55.4) in the intervention group and 59.9 (59.0-60.8) in the control group, yielding a mean difference of -5.4 points (-6.6 to -4.1; p<0.001), exceeding the minimal clinically important difference (MCID) of 3.3 points. At 6 months, physical functioning was higher in the intervention group, exceeding its MCID, whereas the between-group difference in quality of life was less than the MCID. The authors conclude that, among mBC patients, digital PRO monitoring was associated with clinically meaningful reduction in fatigue and with improved physical functioning (visual abstract).