Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial.
Estelle Guerdoux, Louise Coutant, Anas Al Herk et al.
✦ AI-curated · Sources linked
In 30 seconds
The BIO-PSY French, single-centre, open-label randomised controlled trial assessed whether remote patient-reported outcome (PRO) monitoring with tailored interventions improved pain and anxiety after breast biopsy. Adults were assigned to daily phone-based PROs with psycho-oncology contact, electronic PROs, or standard care. Among 193 patients, pain was negligible (median = 0) and did not differ statistically between groups on days 4 or 10. Clinically significant anxiety was less common in both remote-monitoring groups than with standard care on day 4; on day 10, this difference remained significant only for phone-based monitoring.
Key findings
- Among 193 patients, day-4 pain was negligible (median = 0) and did not differ statistically between trial arms at day 4 or day 10 (p > 0.05).
- Clinically significant anxiety was lower in both remote PRO arms than in standard care on day 4 (p < 0.001).
- At day 10, clinically significant anxiety was lower only in the phone-based PRO arm (adjusted p = 0.008).
Why it matters
The findings suggest that pain after breast biopsy may be well controlled under standard care, while structured remote follow-up could help identify and address anxiety. The persistence of an anxiety difference only with phone-based monitoring raises the possibility that human contact contributes to benefit, although the trial does not establish which intervention components account for the result.
What to keep in mind
The trial was monocentric and open-labelled, and follow-up outcomes were assessed only through day 10.