{
  "abstract": "Purpose\n\nAlthough breast biopsy is a routine procedure, it often triggers significant pain and anxiety. Pre-procedural distress has been associated with increased pain and discomfort, and persistent post-biopsy distress may affect psychological and treatment-related outcomes. However, post-biopsy care still lacks standardized follow-up. This study evaluated whether remote monitoring using patient-reported outcomes (PROs) triggering targeted interventions could improve pain and anxiety management after breast biopsy.Methods\n\nBIO-PSY was a French, monocentric, open-labelled, randomized controlled trial. Patients aged ≥ 18 years undergoing breast biopsy were randomized (1:1:1) to daily phone-based PROs (phone contact with a psycho-oncologist for 3 days), e-PROs (electronic interface for 3 days), or standard care. Alerts generated based on PROs thresholds prompted tailored interventions. The primary endpoint was pain on day 4 (0-10 numerical rating scale, phone-assessed). Secondary outcomes included pain at day 10; anxiety and perceived aesthetic impact (days 4 and 10); insomnia (Insomnia Severity Index) at day 10; and strategies for symptoms management.Results\n\nAmong 193 patients, pain was negligible (median = 0), stable, and not statistically different between arms at day 4 and 10 (p > 0.05). The proportion of patients with clinically significant anxiety was lower in the experimental arms than in the control arm at day 4 (p < 0.001) and was lower at day 10 only in the phone-based PRO arm (adjusted p = 0.008).Conclusion\n\nPain after breast biopsy was well controlled across all arms. Remote monitoring using PROs may reduce anxiety, especially with human intervention, supporting its integration into routine post-biopsy care.Clinical trial registration\n\nNCT04456920 (registered on June 23, 2020).",
  "abstract_shown": true,
  "affiliations": [
    "Department of Palliative and Supportive Care, Montpellier Cancer Institute (ICM), University of Montpellier, 208 Avenue Des Apothicaires, 34298, Montpellier, France. estelle.guerdoux@icm.unicancer.fr.",
    "Laboratory Epsylon, EA4556, University Paul Valéry, Montpellier, France. estelle.guerdoux@icm.unicancer.fr.",
    "Department of Palliative and Supportive Care, Montpellier Cancer Institute (ICM), University of Montpellier, 208 Avenue Des Apothicaires, 34298, Montpellier, France.",
    "Laboratory Epsylon, EA4556, University Paul Valéry, Montpellier, France.",
    "Biometrics Unit, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.",
    "Department of Clinical Research and Innovation, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.",
    "Department of Radiology, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.",
    "PINKCC Laboratory, INSERM U1194, Montpellier Cancer Research Institute, University of Montpellier, Montpellier, France."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 11,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Estelle Guerdoux",
      "orcid": "0000-0002-9608-0791"
    },
    {
      "affs": [
        2,
        3
      ],
      "name": "Louise Coutant",
      "orcid": "0009-0007-2567-0667"
    },
    {
      "affs": [
        4
      ],
      "name": "Anas Al Herk",
      "orcid": "0009-0007-3728-8123"
    },
    {
      "affs": [
        5
      ],
      "name": "Laetitia Meignant",
      "orcid": "0009-0001-4661-3561"
    },
    {
      "affs": [
        6
      ],
      "name": "Guillaume Laffargue",
      "orcid": "0000-0002-5489-6848"
    },
    {
      "affs": [
        5
      ],
      "name": "Fanny Salasc",
      "orcid": "0000-0002-6574-1358"
    },
    {
      "affs": [
        6
      ],
      "name": "Jade Pibre"
    },
    {
      "affs": [
        6
      ],
      "name": "Stéphanie Blasco"
    },
    {
      "affs": [
        6
      ],
      "name": "Nolwenn Bignon"
    },
    {
      "affs": [
        2
      ],
      "name": "Muriel Thomaso",
      "orcid": "0000-0002-8567-3874"
    },
    {
      "affs": [
        6,
        7
      ],
      "name": "Stéphanie Nougaret",
      "orcid": "0000-0002-6398-8648"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/6p2ve5ga0pky6.bib",
  "cited_by": 0,
  "doi": "10.1007/s00520-026-11349-8",
  "fulltext_url": "https://europepmc.org/articles/PMC13690837",
  "id": "6p2ve5ga0pky6",
  "issns": [
    "0941-4355",
    "1433-7339"
  ],
  "landing_url": "https://europepmc.org/article/MED/42911430",
  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2730|Cancer survivorship and care"
    ]
  ],
  "openalex": "W7223174009",
  "pdf_url": "https://europepmc.org/articles/PMC13690837?pdf=render",
  "pmcid": "PMC13690837",
  "pmid": "42911430",
  "published": "2026-10-22",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/6p2ve5ga0pky6.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:10Z",
      "native_id": "MED:42911430",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42911430"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|Cancer survivorship and care",
      "subfield": "oncology"
    }
  ],
  "title": "Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial.",
  "title_text": "Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:10Z",
  "url": "https://research.draconitic.com/paper/6p2ve5ga0pky6",
  "venue": "Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer",
  "versions": []
}