Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial

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. 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. 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). 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)