Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Mar 11, 2026
Date Accepted: Sep 9, 2026
Real-Time ePRO Monitoring With Digital Triage and Care-Team Integration in Early Breast Cancer: The ENABLE Randomized Controlled Trial
ABSTRACT
Background:
Digital health applications incorporating electronic patient-reported outcomes measurements (ePROMs) have the potential to improve patient-centered care in oncology by enabling timely symptom monitoring and individualized support. Evidence in early breast cancer remains limited.
Objective:
The randomized-controlled ENABLE trial evaluated whether a digital health application with real-time interventions derived from weekly ePROs could improve health-related quality of life (HRQoL) and treatment satisfaction in patients undergoing systemic breast cancer therapy.
Methods:
Patients were randomized 1:1 to intervention or control during systemic therapy for early breast cancer. The trial was open-label. HRQoL was assessed at six fixed time points using validated questionnaires. In the intervention arm, weekly monitoring of self-rated overall health using the EuroQol Visual Analogue Scale (EQ-VAS) triggered a just-in-time digital triage with care team response (“Reactive PRO Assessment, RPA”). The app also provided educational and organizational support. Primary endpoints were HRQoL (PROMIS-29) and patient satisfaction (PSQ-18).
Results:
Among 487 patients within the mITT population (242 intervention, 245 control), most received neoadjuvant (329/487, 68%) or adjuvant (115/487, 24%) chemotherapy. The mixed-effects model revealed a significant improvement in the PROMIS-29 anxiety (Benjamini-Hochberg–adjusted P=.049), fatigue (P=.004), and social participation (P=.01) domains in favor of the intervention group. The time to deterioration was better for depression (HR 0.66, 95% CI 0.44-0.98), fatigue (HR 0.69, 95% CI 0.54-0.89), and social participation (HR 0.76, 95% CI 0.59-0.97) in the intervention group. No substantial differences in patient satisfaction (PSQ-18) were observed between groups.
Conclusions:
The ENABLE trial demonstrates that real-time, ePRO-triggered interventions can enhance psychological and social aspects of HRQoL during systemic therapy for early breast cancer. While overall satisfaction with digital health support was high across groups, the findings highlight the added value of real-time digital triage in oncology care pathways. Clinical Trial: German Clinical Trials Register DRKS00025611; https://drks.de/search/en/trial/DRKS00025611
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