Real-Time Electronic Patient-Reported Outcome Monitoring With Digital Triage and Care-Team Integration in Early Breast Cancer: ENABLE Randomized Controlled Trial.

In 30 seconds

The multicenter, open-label ENABLE randomized controlled trial compared weekly electronic patient-reported outcome (ePRO) screening with rule-based triage and care-team alerts against an active app-based support comparator in adults starting systemic therapy for stage I-III breast cancer. Among 487 patients in the modified intention-to-treat analysis, end-of-treatment results favored triage for fatigue (-3.90 T-score points), social participation (+2.84), and anxiety (-2.10); all differences were below the 5-point minimally important difference. Effects were domain-specific rather than evidence of a broad health-related quality-of-life improvement.

Key findings

• At end of treatment, fatigue was 3.90 T-score points lower with triage than control (95% CI -5.77 to -2.03; adjusted P=.004).
• Social participation was 2.84 T-score points higher with triage (95% CI 1.18 to 4.49; adjusted P=.01).
• Anxiety was 2.10 T-score points lower with triage (95% CI -3.65 to -0.55; adjusted P=.049).
• Of 209 monitored patients, 160 (76.6%; 95% CI 70.4-81.8) triggered at least 1 alert; no intervention-related harms were identified.

Why it matters

The trial evaluates whether acting on patient-reported symptoms adds value beyond digital education, organizational support, and scheduled outcome collection. Its findings suggest that real-time monitoring linked to a care team may modestly improve selected aspects of quality of life during systemic therapy, while underscoring that alerting alone does not produce a broad or clinically large HRQoL effect.

What to keep in mind

All end-of-treatment differences were below the 5-point minimally important difference, and no single domain or global success rule was prespecified. The comparator was an active app-based intervention, not usual care.