Real-Time Electronic Patient-Reported Outcome Monitoring With Digital Triage and Care-Team Integration in Early Breast Cancer: ENABLE Randomized Controlled Trial
Journal of Medical Internet Research ·
Background: Electronic patient-reported outcomes (ePROs) can support patient-centered oncology care, but in early breast cancer, it is unclear whether real-time ePRO-triggered triage adds benefit beyond lower-intensity app-based support and scheduled ePRO collection. Objective: We tested whether adding weekly ePRO screening, rule-based triage, and care-team escalation to app-based support improves health-related quality of life (HRQoL) during systemic therapy for early breast cancer. Methods: ENABLE was a multicenter, open-label, parallel-group randomized controlled trial at 2 German university hospitals. Adults with early (stage I-III) breast cancer initiating systemic therapy were randomized 1:1 to reactive patient-reported outcome assessment (RPA) or control. Both arms received the ENABLE app with educational and organizational support and scheduled HRQoL assessments at 6 fixed time points; only RPA received weekly EuroQol Visual Analogue Scale screening (trigger: score <50 or ≥10-point decline) followed by symptom assessment, digital triage, and care-team alerts. Patient-Reported Outcomes Measurement Information System-29 was analyzed as an 8-measure HRQoL end-point family (7 domains plus pain intensity); no single domain, composite score, or binary global success rule was prespecified. Group-by-visit mixed-effects models were fitted with Benjamini-Hochberg false-discovery-rate adjustment. The recruitment period was March 22, 2021, to September 8, 2023. Results: Of 605 randomized patients, 487 entered the modified intention-to-treat analysis (RPA: n=242; control: n=245). End-of-treatment between-group differences (RPA minus control, -score points, 95% CI, and adjusted ) were: fatigue −3.90 (95% CI −5.77 to −2.03; =.004), social participation +2.84 (95% CI 1.18 to 4.49; =.01), anxiety −2.10 (95% CI −3.65 to −0.55; =.049), depression −1.95 (95% CI −3.25 to −0.65; =.10), sleep disturbance −1.82 (95% CI −3.43 to −0.20; =.051), pain interference −1.44 (95% CI −3.38 to 0.49; =.18), physical function +1.33 (95% CI −0.22 to 2.88; =.18), and pain intensity −0.26 (95% CI −0.73 to 0.21; =.32; 0‐10 scale). All -score differences were below the 5-point minimally important difference (MID). Exploratory time-to-deterioration analyses favored RPA for fatigue (hazard ratio [HR] 0.69, 95% CI 0.54‐0.89), social participation (HR 0.76, 95% CI 0.59-0.97), and depression (HR 0.66, 95% CI 0.44-0.98). Of 209 monitored RPA patients, 160 (76.6%; 95% CI 70.4‐81.8) triggered at least 1 alert. No intervention-related harms were identified. Conclusions: ENABLE tests real-time, rule-based ePRO triage with care-team escalation against an active digital comparator rather than usual care, isolating the response pathway itself; it extends this design from metastatic disease into early breast cancer and escalates to the care team rather than to the patient alone. Benefits were domain-specific and sub-MID, in anxiety, fatigue, and social participation, tempering the expectation of a global HRQoL effect. For practice, symptom-triggered triage is a supportive-care workflow tool worth embedding where alerts reach a team that acts and documents, not a stand-alone remedy for treatment-related morbidity. Trial Registration: German Clinical Trials Register DRKS00025611; https://drks.de/search/en/trial/DRKS00025611 International Registered Report Identifier (IRRID): RR2-10.2196/69855