{
  "abstract": "Introduction: In breast cancer, psychological distress predicts poorer quality of life, adherence and clinical outcomes. Most digital psychosocial interventions rely on static content and infrequent monitoring, missing patients’ evolving emotional states. Therefore, a key clinical challenge is the timely identification of these emotional fluctuations and the tailoring of interventions accordingly. We have developed a large language model (LLM)-enabled emotion management system, whose core methodological innovation lies in leveraging patient-generated text from social media platforms as the primary analytical source to deliver guideline-aligned personalised supportive interventions for patients. The study aims to establish whether this intervention improves health-related quality of life (HRQoL), psychological outcomes, symptom burden while reducing unplanned hospitalisations in patients with breast cancer.\n\nMethods and analysis: This prospective stratified block randomised controlled trial targets a total sample of 440 eligible patients with breast cancer with 1:1 allocation, recruited from six tertiary hospitals stratified by regional economic levels. Eligibility criteria include histologically confirmed primary breast cancer, smartphone access and regular social media use; those with cognitive impairment, concurrent malignancies or active suicidal ideation are excluded. The intervention group receives usual care plus an LLM-based emotion management system that analyses patient text to generate personalised emotion labels and match symptom keywords, then provides tailored evidence-based interventions. The control group receives usual care. Assessments are conducted at baseline, 1, 3 and 6 months. The primary outcome is HRQoL assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) summary score, with the primary endpoint defined as the 6-month assessment after randomisation; secondary outcomes cover individual HRQoL domains of the EORTC QLQ-C30 to examine effects on function and symptom status, anxiety (Generalised Anxiety Disorder-7), depression (Patient Health Questionnaire-9), symptom burden (Memorial Symptom Assessment Scale), rate of unplanned hospitalisation and time to first unplanned hospitalisation.\n\nEthics and dissemination: This trial is conducted in accordance with the principles of the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice. Ethical approval was obtained from the ethics committees of 6 hospitals. Written informed consent was collected from all participants before enrolment. Participants can withdraw freely at any time without prejudice to routine clinical care. Trial results will be submitted for publication in peer-reviewed journals.\n\nTrial registration number: NCT07452055.",
  "abstract_shown": true,
  "affiliations": [
    "Nanfang Hospital, Southern Medical University, Guangzhou, China",
    "School of Nursing, Southern Medical University, Guangzhou, China",
    "State Key Laboratory of Multi-Organ Injury Prevention and Treatment, Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China",
    "The First Affiliated Hospital of Army Medical University, Chongqing, China",
    "Affiliated Hospital of Guangdong Medical University, Zhanjiang, China",
    "The Second Nanning People’s Hospital, Nanning, Guangxi, China",
    "Zigong First People's Hospital, Zigong, Sichuan, China",
    "The Affiliated Huizhou Hospital, Guangzhou Medical University, Huizhou, China"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 25,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Meiqin Luo",
      "orcid": "0009-0006-0580-9679"
    },
    {
      "affs": [
        2
      ],
      "name": "Chongyang Duan"
    },
    {
      "affs": [
        0
      ],
      "name": "Wenji Li"
    },
    {
      "affs": [
        3
      ],
      "name": "Ying Yang"
    },
    {
      "affs": [
        4
      ],
      "name": "Hongpo Xie"
    },
    {
      "affs": [
        5
      ],
      "name": "Hua Lin"
    },
    {
      "affs": [
        6
      ],
      "name": "Changju Liao"
    },
    {
      "affs": [
        7
      ],
      "name": "Linzhi Li"
    },
    {
      "affs": [
        0
      ],
      "name": "Huihui Zhao"
    },
    {
      "affs": [
        3
      ],
      "name": "Chaixiu Li"
    },
    {
      "affs": [
        4
      ],
      "name": "Xiaoting Tan"
    },
    {
      "affs": [
        5
      ],
      "name": "Xiaoxue Wei"
    },
    {
      "affs": [
        6
      ],
      "name": "Xiaorong Bian"
    },
    {
      "affs": [
        7
      ],
      "name": "Huan Liu"
    },
    {
      "affs": [
        0
      ],
      "name": "Yinghua Zeng"
    },
    {
      "affs": [
        0
      ],
      "name": "Hui Yang"
    },
    {
      "affs": [
        3
      ],
      "name": "Yinhuan Wang"
    },
    {
      "affs": [
        4
      ],
      "name": "Di Lin"
    },
    {
      "affs": [
        5
      ],
      "name": "Xin Liu"
    },
    {
      "affs": [
        6
      ],
      "name": "Xiaoli Gan"
    },
    {
      "affs": [
        7
      ],
      "name": "Yu Sun"
    },
    {
      "affs": [
        0
      ],
      "name": "Qiuyan Ren"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Yan He"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Jiale Sun"
    },
    {
      "affs": [
        0
      ],
      "name": "Yanni Wu",
      "orcid": "0000-0003-1938-2785"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/429vxd0gzaqg6.bib",
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  "doi": "10.1136/bmjopen-2026-126107",
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  "pmcid": "PMC13723869",
  "pmid": "42951296",
  "published": "2026-10-28",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/429vxd0gzaqg6.ris",
  "sources": [
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      "first_seen": "2026-10-30T12:19:44Z",
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|Cancer survivorship and care",
      "subfield": "oncology"
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  ],
  "title": "Efficacy of a large language model-driven application for emotion management in breast cancer patients (EMBRACE): protocol for a multicentre randomised controlled trial",
  "title_text": "Efficacy of a large language model-driven application for emotion management in breast cancer patients (EMBRACE): protocol for a multicentre randomised controlled trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-05T12:20:36Z",
  "url": "https://research.draconitic.com/paper/429vxd0gzaqg6",
  "venue": "BMJ Open",
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