Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial
In brief
Remote follow-up reduced clinically significant anxiety after breast biopsy
In this 193-patient French trial, pain scores were negligible and did not differ between remote-monitoring and usual-care groups. Fewer patients had clinically significant anxiety with either remote approach on day 4, but the difference persisted to day 10 only with phone follow-up from a psycho-oncologist. The study supports anxiety-focused follow-up, though its single-center design and unreported effect size limit certainty.
- Journal
- Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Q1)
- Published
- 22 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Estelle Guerdoux, Louise Coutant, Anas Al Herk, Laetitia Meignant, Guillaume Laffargue, Fanny Salasc, et al.
- PMID
- 42911430
- DOI
- 10.1007/s00520-026-11349-8
Why clinicians should know about it
- Picked for Breast and Endocrine Surgery (top studies of the week, 25 October 2026): Randomized trial of PRO monitoring after breast biopsy
Abstract
PURPOSE: Although 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: BIO-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: Among 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: Pain 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: NCT04456920 (registered on June 23, 2020).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.