Journal Article Randomized Controlled Trial Multicenter Study Epublish
PubMed: 42954133 DOI: 10.2196/95155
Real-Time Electronic Patient-Reported Outcome Monitoring With Digital Triage and Care-Team Integration in Early Breast Cancer: ENABLE Randomized Controlled Trial.
J Med Internet Res 28:e95155
Authors: Thomas M Deutsch, Léa L Volmer, Manuel Feisst, Marcus Heise, Kathrin Hassdenteufel, Lara M Tretschock, André Pfob, Christiane Breit, Ekaterina Martynenko, Stefan Stefanovic, Nima Ghalekhani, Stephanie Wallwiener, Eva Kantelhardt, Marlene Martin, Armin Bauer, Tjeerd M H Dijkstra, Laura L Michel, Tobias Engler, Andreas D Hartkopf, Nico Pfeifer, Sara Y Brucker, Andreas Schneeweiss, Markus Wallwiener
Affiliations
- Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Baden Wuerttemberg, Germany.
- Department of Gynecology and Obstetrics, Mannheim University Hospital, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, Mannheim, Baden Wuerttemberg, 68167, Germany, +49 621 383 2288.
- Department of Women's Health, University of Tübingen, Tübingen, Germany.
- Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.
- Department of Gynecology, University Hospital Halle (Saale), Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
- Institute of General Practice and Family Medicine, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
- Breast Center Heidelberg, Hospital St. Elisabeth, Heidelberg, Germany.
- Department of Obstetrics and Prenatal Medicine, University Hospital Halle (Saale), Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
- Institute of Women's Health GmbH, Tübingen, Germany.
- National Center for Tumor Diseases (NCT), Heidelberg, Germany.
- Methods in Medical Informatics, Department of Computer Science, University of Tübingen, Tübingen, Germany.
- Center for Innovative Care, University Hospital Tübingen, Tübingen, Germany.
- Institute for Bioinformatics and Medical Informatics, University of Tübingen, Tübingen, Germany.
- German Cancer Research Center (DKFZ), Heidelberg, Germany.
Abstract
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, T-score points, 95% CI, and adjusted P) were: fatigue -3.90 (95% CI -5.77 to -2.03; P=.004), social participation +2.84 (95% CI 1.18 to 4.49; P=.01), anxiety -2.10 (95% CI -3.65 to -0.55; P=.049), depression -1.95 (95% CI -3.25 to -0.65; P=.10), sleep disturbance -1.82 (95% CI -3.43 to -0.20; P=.051), pain interference -1.44 (95% CI -3.38 to 0.49; P=.18), physical function +1.33 (95% CI -0.22 to 2.88; P=.18), and pain intensity -0.26 (95% CI -0.73 to 0.21; P=.32; 0-10 scale). All T-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.
MeSH
Depression, Quality Of Life, Breast Neoplasms, Pain, Triage, Neoplasms, Fatigue, Breast, Therapeutics