{
  "abstract": "Background\n\nElectronic 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\n\nWe 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\n\nENABLE 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\n\nOf 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\n\nENABLE 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.",
  "abstract_shown": true,
  "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."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 23,
  "authors": [
    {
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        0,
        1
      ],
      "name": "Thomas M Deutsch",
      "orcid": "0000-0003-0621-1290"
    },
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        2
      ],
      "name": "Léa L Volmer",
      "orcid": "0009-0008-7643-3327"
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        3
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      "name": "Manuel Feisst",
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        5
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      "name": "Marcus Heise",
      "orcid": "0000-0002-8419-6412"
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      "name": "Kathrin Hassdenteufel",
      "orcid": "0000-0003-0141-7425"
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      "name": "Lara M Tretschock",
      "orcid": "0009-0002-6381-0978"
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        0,
        6
      ],
      "name": "André Pfob",
      "orcid": "0000-0001-6140-9895"
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      "name": "Christiane Breit",
      "orcid": "0009-0005-2035-9058"
    },
    {
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        0
      ],
      "name": "Ekaterina Martynenko",
      "orcid": "0000-0003-3478-9807"
    },
    {
      "affs": [
        1
      ],
      "name": "Stefan Stefanovic",
      "orcid": "0000-0002-9652-6036"
    },
    {
      "affs": [
        4
      ],
      "name": "Nima Ghalekhani",
      "orcid": "0000-0001-8524-8811"
    },
    {
      "affs": [
        7
      ],
      "name": "Stephanie Wallwiener",
      "orcid": "0000-0003-2045-650X"
    },
    {
      "affs": [
        4
      ],
      "name": "Eva Kantelhardt",
      "orcid": "0000-0001-7935-719X"
    },
    {
      "affs": [
        4
      ],
      "name": "Marlene Martin",
      "orcid": "0000-0001-8727-0289"
    },
    {
      "affs": [
        8
      ],
      "name": "Armin Bauer",
      "orcid": "0009-0006-2885-0965"
    },
    {
      "affs": [
        8
      ],
      "name": "Tjeerd M H Dijkstra",
      "orcid": "0000-0002-4450-701X"
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    {
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        9
      ],
      "name": "Laura L Michel",
      "orcid": "0000-0002-7784-2826"
    },
    {
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        2
      ],
      "name": "Tobias Engler",
      "orcid": "0000-0002-8063-2053"
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    {
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        2
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      "name": "Andreas D Hartkopf",
      "orcid": "0000-0003-1227-1118"
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    {
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        10,
        11,
        12
      ],
      "name": "Nico Pfeifer",
      "orcid": "0000-0002-4647-8566"
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    {
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        2
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      "name": "Sara Y Brucker",
      "orcid": "0000-0001-5162-1542"
    },
    {
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        9,
        13
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      "name": "Andreas Schneeweiss",
      "orcid": "0000-0002-2429-4512"
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    {
      "affs": [
        4
      ],
      "name": "Markus Wallwiener",
      "orcid": "0000-0002-4139-9340"
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  "bibtex": "https://research.draconitic.com/paper/5nm0s5x8gx0bn.bib",
  "cited_by": 0,
  "doi": "10.2196/95155",
  "fulltext_url": "https://europepmc.org/articles/PMC13717432",
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  "native_subjects": [
    [
      "heading",
      "Breast Cancer"
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    [
      "heading",
      "Original Paper"
    ],
    [
      "heading",
      "Patient-Reported Outcome Measures (PROMs)"
    ],
    [
      "heading",
      "Registered Report"
    ],
    [
      "heading",
      "Web-based and Mobile Health Interventions"
    ],
    [
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      "R858-859.7"
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  "pdf_url": "https://europepmc.org/articles/PMC13717432?pdf=render",
  "pmcid": "PMC13717432",
  "pmid": "42954133",
  "published": "2026-10-01",
  "publisher": "JMIR Publications Inc.",
  "ris": "https://research.draconitic.com/paper/5nm0s5x8gx0bn.ris",
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  "subjects": [
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      "field": "medicine",
      "origin": "openalex:2730|Cancer survivorship and care",
      "subfield": "oncology"
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  ],
  "title": "Real-Time Electronic Patient-Reported Outcome Monitoring With Digital Triage and Care-Team Integration in Early Breast Cancer: ENABLE Randomized Controlled Trial.",
  "title_text": "Real-Time Electronic Patient-Reported Outcome Monitoring With Digital Triage and Care-Team Integration in Early Breast Cancer: ENABLE Randomized Controlled Trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-11-06T14:20:42Z",
  "url": "https://research.draconitic.com/paper/5nm0s5x8gx0bn",
  "venue": "Journal of medical Internet research",
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}