This multicenter RCT (PRO-B, n=909, Germany, 52 centers, May 2021–February 2024) tested weekly smartphone-based PRO monitoring with automated alerts to nurses/physicians (contacted within 48 hours) versus quarterly PRO monitoring without alerts in women with metastatic breast cancer (mBC) on systemic therapy, over 12 months of follow-up.
At 6 months, the intervention group had significantly lower adjusted mean fatigue T-scores (54.5 vs 59.9; mean difference −5.4 points, 95% CI −6.6 to −4.1; P<0.001), exceeding the MCID of 3.3 points. Physical functioning also improved beyond its MCID (mean difference +4.0, 95% CI 2.6–5.4). The between-group quality-of-life difference was 0.8 points, below the MCID of 2.9.
- Baseline fatigue scores differed between groups (57.6 vs 60.2; P<0.001), suggesting randomization imbalance that could inflate the intervention effect despite ANCOVA adjustment. - Trial was conducted in Germany with specific health-insurer enrollment requirements, limiting generalizability. - No blinding was possible; alert-triggered nursing/physician contact was not standardized, introducing variability in the actual intervention delivered.
Weekly digital PRO monitoring with alert-based nurse or physician callbacks produces clinically meaningful reductions in fatigue and improved physical function in women with mBC on systemic therapy. Oncology teams should consider integrating structured PRO alert systems into routine mBC care, using existing digital infrastructure.
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