TOPLINE

Weekly electronic patient-reported outcome (PRO) monitoring with automated alerts to clinicians was associated with a clinically meaningful reduction in fatigue at 6 months and improved physical functioning at several timepoints compared with usual care in patients with metastatic breast cancer.

METHODOLOGY

• A growing body of evidence has suggested that digital PRO monitoring in advanced cancer can improve symptom control and may even prolong survival, but data specific to metastatic breast cancer remain limited.
• Researchers conducted a multicenter randomized clinical trial, enrolling 924 women with metastatic breast cancer receiving systemic therapy across 52 certified breast cancer centers in Germany. A total of 909 patients (median age 50 years) were included in the primary analysis, with 456 in the intervention group and 453 in the control group.
• Participants in the intervention group completed weekly PRO questionnaires (51-57 items) via smartphone using validated short forms from the European Organization for Research and Treatment of Cancer computerized adaptive testing core item bank, while the control group received usual care with quarterly PRO questionnaires and no alerts.
• Automated alerts based on predefined PRO deterioration were emailed to trained local nurses or physicians who contacted patients by telephone within 48 hours to provide clinical support.
• The primary outcome was fatigue at 6 months, with secondary outcomes including fatigue, physical functioning, and health-related quality of life (HRQOL) over 12 months.

TAKEAWAY

• At 6 months, adjusted mean fatigue was 5.4 points lower in the intervention group — 54.5 vs 59.9 (P < .001), exceeding the minimal clinically important difference of 3.3 points. Between-group differences in fatigue favored the intervention at all timepoints: -5.2 at 3 months, -6.8 at 9 months, and -5.2 at 12 months.
• Physical functioning improvements exceeded the minimal clinically important difference of 3.2 points at multiple timepoints, with between-group mean differences of 3.7 at 3 months, 4.0 at 6 months, and 5.1 at 9 months.
• The between-group difference in HRQOL at 6 months was 0.8 points (95% CI, 0.02-1.5), which did not reach the minimal clinically important difference of 2.9 points, and no significant difference was observed in time to first systemic therapy change (adjusted hazard ratio [aHR], 0.89; 95% CI, 0.74-1.08).
• In an exploratory analysis, the intervention was also associated with longer overall survival at 12 months (87.6% vs 84.7%; aHR, 0.72), although survival was a secondary outcome and the study was not designed to establish a survival benefit.

IN PRACTICE

“This randomized clinical trial found that digital PRO monitoring was associated with clinically meaningful reductions in fatigue and improved physical functioning,” the study authors wrote. “These findings support further evaluation of alert-based PRO monitoring in routine oncology care.”

SOURCE

The study, led by Maria M. Karsten, Dr habil, Department of Gynecology with Breast Center, Charité-Universitätsmedizin Berlin in Berlin, Germany, was published online on August 6 in JAMA Oncology.

LIMITATIONS

The study had several important limitations. Only patients with smartphone access and German language proficiency could be enrolled, limiting generalizability. Baseline self-reported measures including PROs were collected after randomization, and although study group assignment was not explicitly disclosed before baseline completion, the trial was not blinded and participants may have become aware of allocation because follow-up schedules differed, potentially introducing expectancy effects or contributing to baseline imbalances. Questionnaire completion rates were higher in the intervention group and dropout patterns differed between groups, raising the possibility of selection bias despite consistent sensitivity analyses. The primary endpoint was changed early in the trial from 12-month to 6-month fatigue, which should be considered when interpreting 12-month estimates. Survival status was obtained through site follow-up without registry linkage, and because loss to follow-up was higher in the control group, informative censoring could not be excluded. Healthcare utilization data were derived from claims and limited to approximately 26% of the full cohort, limiting generalizability of these findings.

DISCLOSURES

This study received funding from a public grant provided by the Innovation Committee of the Federal Joint Committee (Innovationsausschuss des Gemeinsamen Bundesausschusses; grant number 01NVF19013). Karsten disclosed receiving grants from Gemeinsamer Bundesausschuss during the conduct of the study as well as personal fees from Pfizer and Gilead. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.