Remote follow-up after breast biopsy reduces anxiety, not pain

A randomized trial at a French cancer center found that remote follow-up based on patient-reported outcomes did not improve post-biopsy pain, which was minimal in all three study groups, but was associated with lower anxiety than standard care. The BIO-PSY trial enrolled 193 women undergoing diagnostic breast biopsy and compared daily telephone consultations with a psycho-oncologist, daily electronic self-reporting through a smartphone or tablet, and usual post-procedure care. At day 4, the median pain score was 0 in every group, with no statistically significant difference among the arms.

Anxiety, by contrast, was significantly lower in both monitored groups, with the advantage persisting to day 10 in the telephone arm. The source article reports that approximately 1.6 million women in the United States and 1.9 million in Europe undergo the procedure each year, and roughly 80 percent ultimately receive benign results. Nevertheless, patients may experience fear not only of pain but also of what a suspicious imaging finding might mean.

Distress can begin before the procedure and persist while patients wait for pathology results, and pre-biopsy distress has been associated with greater procedural pain and discomfort. Even after a benign result, some patients retain higher levels of distress than people without a history of biopsy. BIO-PSY therefore tested whether a brief, structured remote intervention could identify symptoms early and provide targeted support during the interval surrounding the biopsy and the wait for results.

BIO-PSY was a prospective, open-label, single-center randomized controlled trial. Eligible participants were women aged 18 or older who underwent diagnostic breast biopsy at the cancer center between March 2021 and July 2023. They were allocated in a one-to-one-to-one ratio to the telephone-based patient-reported outcome arm, the electronic patient-reported outcome arm, or the control group receiving standard care.

Randomization was stratified by biopsy modality, Breast Imaging Reporting and Data System classification, and baseline pain below 4 or at least 4 on a 0-to-10 numerical rating scale. Physicians, radiology technicians, and statisticians were blinded to allocation, while patients and psycho-oncologists could not be. The study, registered as NCT04456920, had pain assessed by telephone on day 4 as its primary outcome.

Its sample-size calculation targeted a two-point reduction in mean pain relative to usual care, based on a small departmental pilot of 25 patients whose estimated mean pain score was 5 on the 10-point scale. The two active approaches shared the same symptom thresholds and response strategies. In the telephone arm, a psycho-oncologist called each patient on days 1, 2, and 3 for a semi-structured conversation grounded in cognitive-behavioral therapy.

Most calls lasted about 20 minutes, although sessions ranged from approximately 5 to 40 minutes when anxiety-related concerns required more extensive discussion. In the electronic arm, patients entered pain, anxiety, aesthetic concerns, adverse events, and concomitant treatments into the EXOLIS interface, which took less than four minutes to complete. Automated reminders supported completion, and alerts were generated when predefined thresholds were crossed.

Psycho-oncology staff monitored alerts six days per week, excluding Sundays, and contacted patients who met a threshold within 24 hours. Participants without a smartphone were lent tablets and 4G devices, allowing them to use the electronic pathway. Control patients received routine post-procedure instructions and were advised to contact the department if complications arose, but they had no structured symptom assessment during days 1 to 3.

Thresholds determined the response in both intervention groups. A pain score of 4 or higher triggered tailored advice, including the use of paracetamol and local ice when appropriate, together with discussion of cognitive or environmental strategies that the patient had previously found useful. Anxiety scores of 4 or higher prompted exploration and reframing of the patient’s thoughts, followed by instruction in paced breathing at 0.10 Hz for five minutes three times daily.

Patients reporting substantial aesthetic discomfort could describe their concerns, receive information about the expected course of the change, and discuss further management. Suspected biopsy complications were escalated to the radiology team. During the three intervention days, 18 of the 60 interviewed patients in the telephone arm received tailored management on day 1, seven on day 2, and four on day 3.

These contacts could include pharmacological measures, non-pharmacological interventions, or both. Pain was negligible at both measured time points. On day 4, the median score was 0 in the telephone, electronic, and control groups, with an interquartile range of 0 to 1 and a non-significant between-group result of p = 0.59.

Only three participants, 1.7 percent of those assessed, reported pain intense enough to trigger tailored management. By day 10, the median remained 0 in every arm, and seven patients reported pain of at least 4, again with no significant difference among groups. The investigators said the much lower pain intensity than anticipated created a floor effect that limited their ability to detect a difference in the primary endpoint.

The original calculation had relied on the imprecise estimate from the 25-patient pilot, and that assumption did not hold in the randomized trial. With pain already close to zero across all arms, the study could not establish whether either remote approach had an analgesic advantage over standard care. Anxiety showed the clearest difference between the monitored and usual-care groups.

At day 4, median anxiety scores were 2 in both the telephone and electronic arms, compared with 4 in the control arm, with an overall p value below 0.001. The proportion scoring at least 4 was also significantly lower in each experimental group than in the control group, with adjusted p values below 0.001 for the telephone comparison and 0.005 for the electronic comparison. At day 10, the lower proportion of clinically significant anxiety was maintained in the telephone arm, with an adjusted p value of 0.008, but not in the electronic arm.

Telephone descriptions offered a possible explanation for the different duration of benefit. Psycho-oncologists’ notes suggested that patients’ anxiety was driven less by the biopsy itself than by uncertainty surrounding the diagnostic process while they waited for results. This interpretation was not collected through a formal qualitative analysis and was not based on a direct measure of intolerance of uncertainty, so it remains hypothesis-generating.

Telephone consultations combined symptom assessment with an opportunity to clarify concerns and consider realistic interpretations. The same intervention was also available after an electronic alert, but the telephone arm provided routine contact with a clinician for three consecutive days, including patients whose scores did not cross intervention thresholds. The trial could not determine whether the sustained day-10 difference arose from the frequency of contact, the therapeutic conversation, the timing of support, or another feature of the intervention.

Several secondary outcomes showed no significant between-group differences, while the number of participants receiving tailored management did vary. Median perceived aesthetic impact was 0 in every arm on days 4 and 10, and few participants reported substantial aesthetic concerns. Insomnia Severity Index scores did not differ significantly at day 10, nor did the proportion reaching clinical levels of insomnia.

At day 4, however, tailored management was provided to 28.9 percent of participants: 13.6 percent in the telephone arm, 36.1 percent in the electronic arm, and 36.7 percent in the control group. The overall difference was significant at p = 0.007, with adjusted p values of 0.02 for telephone versus electronic monitoring and 0.01 for telephone versus control. Biopsy complications were rare: two participants experienced bleeding, one in the electronic arm on the day of biopsy and one in the control arm on day 4.

No adverse events were attributed to the study interventions. Between days 1 and 10, 78 women, or 40.6 percent, reported concomitant treatments, with no significant difference among the three groups. Treatments included analgesics, anxiolytics, antidepressants, hypnotics, and other measures or non-pharmacological interventions.

Satisfaction with the study was high overall: the median day-10 satisfaction score was 10, with 57.8 percent of participants giving a score of 10 and 32.4 percent giving a score of 9. The difference between arms was not significant, and the researchers did not formally assess acceptability, preferences for human versus digital contact, cost-effectiveness, or staff workload. The trial also used an open-label design, which could have influenced how patients reported their symptoms.

Its single-center setting and relatively limited sample may restrict generalizability, and anxiety was a secondary outcome in a trial powered primarily to detect a reduction in pain. Anxiety was measured with a single-item numerical rating scale rather than a validated multidimensional instrument, limiting characterization of anxiety beyond its reported intensity. The results should therefore be read as evidence from one open-label, single-center trial of 193 women, not proof that remote monitoring changes every aspect of biopsy care.

The randomized comparison showed a short-term anxiety advantage for both forms of structured remote follow-up and a persistent advantage for the telephone intervention, even though physical pain was uniformly low. The investigators could not isolate the effects of individual components such as cognitive reframing, breathing instruction, scheduled calls, or alert-triggered support, nor directly test diagnostic uncertainty as a mechanism. Broader replication would be needed before drawing conclusions about routine implementation across hospitals and health systems.

The authors proposed future trials with anxiety or distress as the primary outcome, longer follow-up, formal evaluation of diagnostic uncertainty, and assessment of workload, implementation feasibility, cost-effectiveness, and longer-term patient-reported benefits.

Subject of Research: Randomized trial of remote patient-reported outcome monitoring for pain and anxiety after diagnostic breast biopsy

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

Article References: Guerdoux, E., Coutant, L., Al Herk, A., Meignant, L., Laffargue, G., Salasc, F., Pibre, J., Blasco, S., Bignon, N., Thomaso, M., & Nougaret, S. (2026). Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial. Supportive Care in Cancer, 34(11), Article 1140. https://doi.org/10.1007/s00520-026-11349-8

Image Credits: AI Generated

DOI: 10.1007/s00520-026-11349-8

Keywords: breast biopsy, patient-reported outcomes, anxiety, remote monitoring, psycho-oncology, randomized controlled trial, electronic health, supportive care, breast imaging, diagnostic uncertainty, Impact, remote