18 and older, female only, with Breast Cancer or Biopsy Wound. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants by Pain Intensity at Day 4 Post Breast Biopsy With a Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects (Smartphone or Tablet)) Compared of the Standard Follow upPrimary· From date of randomization until the Day 4 post biopsy
Pain score assessed (by phone) via a numeric pain scale (from 0 "no pain" to 10 "maximal pain")completed 4 days after biopsy (Day 4).
No pain (0) on a a numeric pain scale
Group
Value
95% CI
Experimental Group 1
39
Experimental Group 2
43
Control Group
36
Low pain score (1 to 3) on a a numeric pain scale
Group
Value
95% CI
Experimental Group 1
19
Experimental Group 2
17
Control Group
22
Moderate pain Score (4 to 5) on a a numeric pain scale
Group
Value
95% CI
Experimental Group 1
0
Experimental Group 2
1
Control Group
1
Intense pain Score (6 to 7) on a a numeric pain scale
Group
Value
95% CI
Experimental Group 1
0
Experimental Group 2
0
Control Group
1
Pain Intensity During the Consultation of Results Announcement After a Breast Biopsy Between the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) Compared to the Standard Follow upSecondary· From date of randomization until the Day 10 post biopsy
Pain score assessed using a numeric pain scale (from 0 "no pain" to 10 "maximal pain") administered after to biopsy and during the consultation of results announcement (approximately Day 10).
Pain score (0,10) at J0 on a numeric pain scale
Group
Value
95% CI
Experimental Group 1
1
0 – 8
Experimental Group 2
1
0 – 9
Control Group
1
0 – 9
Pain score (0,10) at J10 on a numeric pain scale
Group
Value
95% CI
Experimental Group 1
0
0 – 5
Experimental Group 2
0
0 – 4
Control Group
0
0 – 5
the Benefit According to the Type of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) on the Pain Intensity of Patients at 4 Days (D4) and During the Consultation of Results Announcement After a Breast Biopsy.Secondary· From date of randomization until the Day 4 / Day 10 post biopsy
Pain score assessed using a numeric pain scale (from 0 "no pain" to 10 "maximal pain") administered after to biopsy, at 4 days and 10 days post biopsy
Pain score (from 0 to10) at biopsy day on a numeric pain scale
Group
Value
95% CI
Experimental Group 1
2.08
± 2.50
Experimental Group 2
1.98
± 2.21
Control Group
1.86
± 1.78
Pain score (from 0 to 10) Day 4 post biopsy on a numeric pain scale
Group
Value
95% CI
Experimental Group 1
0.47
± 0.78
Experimental Group 2
0.54
± 1.03
Control Group
0.65
± 1.12
Pain score (from 0 to 10) Day 10 post biopsy on a numeric pain scale
Group
Value
95% CI
Experimental Group 1
0.75
± 1.35
Experimental Group 2
0.54
± 1.10
Control Group
0.54
± 0.99
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Anxiety Intensity of Patients at 4 Days and During the Consultation of Results Announcement, After a Breast Biopsy.Secondary· From date of randomization until the Day 4 and Day 10 post biopsy
Anxiety score assessed using a numeric anxiety scale (from 0 "no anxiety" to 10 "maximal anxiety") administered after to biopsy, at 4 days (Day 4) and 10 days (Day 10)
Anxiety score (0,10) at J0 on a numeric anxiety scale
Group
Value
95% CI
Experimental Group 1
4.52
± 3.02
Experimental Group 2
4.12
± 3.31
Control Group
4.57
± 3.27
Anxiety score (0,10) at J4 a numeric anxiety scale
Group
Value
95% CI
Experimental Group 1
1.88
± 1.63
Experimental Group 2
2.51
± 2.75
Control Group
3.80
± 2.50
Anxiety score (0,10) at J10 a numeric anxiety scale
Group
Value
95% CI
Experimental Group 1
3.43
± 3.02
Experimental Group 2
3.83
± 3.00
Control Group
4.65
± 3.19
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Esthetic Impact of Patients at 4 and 10 Days (D4, D10) After a Breast Biopsy.Secondary· From date of randomization until the Day 4 and Day 10 post biopsy
Esthetic impact score assessed using a numeric esthetic scale (from 0 "no impact" to 100 "maximal impact") administered after to biopsy, at 4 days and 10 days post biopsy
Esthetic Impact (0-100) at J0 on a numeric scale
Group
Value
95% CI
Experimental Group 1
4.29
± 10.88
Experimental Group 2
4.06
± 8.49
Control Group
6.41
± 12.77
Esthetic Impact (0-100) at J4 on a numeric scale
Group
Value
95% CI
Experimental Group 1
7.69
± 19.00
Experimental Group 2
10.05
± 21.77
Control Group
4.18
± 8.43
Esthetic Impact (0-100) at J10 on a numeric scale
Group
Value
95% CI
Experimental Group 1
8.69
± 17.08
Experimental Group 2
8.54
± 15.91
Control Group
3.08
± 5.84
the Benefit According to the Type of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) on the Insomnia of Patients at 10 Days (About Day 10), After a Breast Biopsy.Secondary· From date of randomization until the Day 10 post biopsy
Insomnia score assessed using the Index of Severity of Insomnia (from 0 "no insomnia" to 28 "maximal insomnia") administered at 10 days post biopsy
Insomnia score (0 to 28) at J0
Group
Value
95% CI
Experimental Group 1
7.88
± 5.90
Experimental Group 2
7.42
± 5.97
Control Group
7.22
± 5.57
Insomnia score (0 to 28) at J10
Group
Value
95% CI
Experimental Group 1
7.43
± 6.43
Experimental Group 2
6.65
± 5.95
Control Group
7.34
± 5.91
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's ManagementSecondary· From date of randomization until the Day 4 and the Day 10 post biopsy
Number of alerts that generated a phone call or number of phone calls generated directly by the patient and patient care accordingly.
Phone call
Group
Value
95% CI
Experimental Group 1
60
Experimental Group 2
62
Control Group
62
No phone call
Group
Value
95% CI
Experimental Group 1
0
Experimental Group 2
1
Control Group
0
No data
Group
Value
95% CI
Experimental Group 1
3
Experimental Group 2
2
Control Group
3
the Use of a Biopsy-related Drug Intervention in Patients With E-health Interventions (Phone Consultation or Smartphone), With the Standard Follow-up, at 10 Days After a Breast Biopsy.Secondary· From date of randomization until the Day 4 and Day 10 post biopsy
Quantity, nature and dose of treatments used for the biopsy and its aftermath.
concomitant treatment
Group
Value
95% CI
Experimental Group 1
23
Experimental Group 2
28
Control Group
27
No concomitant treatment
Group
Value
95% CI
Experimental Group 1
40
Experimental Group 2
36
Control Group
38
No data
Group
Value
95% CI
Experimental Group 1
0
Experimental Group 2
1
Control Group
0
Adverse Events in Patients With E-health Interventions (Phone Consultation With a Professional or Connected Objects), With the Standard Follow-up, During the Consultation of Results Announcement (About D10) After a Breast Biopsy.Secondary· From date of randomization until the Day 4 and the Day 10 post biopsy
Adverse event in particular bleeding and infection due to biopsy recorded at 4 days (Day 4) and during the consultation of results announcement (about Day 10) by NCI-CTCAE 5.0
Bleeding
Group
Value
95% CI
Experimental Group 1
0
Experimental Group 2
1
Control Group
1
no bleeding
Group
Value
95% CI
Experimental Group 1
63
Experimental Group 2
64
Control Group
64
Infection
Group
Value
95% CI
Experimental Group 1
0
Experimental Group 2
0
Control Group
0
no infection
Group
Value
95% CI
Experimental Group 1
63
Experimental Group 2
65
Control Group
65
Assess Satisfaction With Specific Study Management.Secondary· at the Day 10 post biopsy
Number of positive responses to satisfaction questions (from 0 (no satisfy) to 10 (veryy satisfy) related to the number of solicitations for the study and how interventions are communicated.
No response 1, 2, 3, 4, 5, and 6 done.
7 on a numeric scale (from 0 to 10)
Group
Value
95% CI
Experimental Group 1
2
Experimental Group 2
1
Control Group
1
8 on a numeric scale (from 0 to 10)
Group
Value
95% CI
Experimental Group 1
2
Experimental Group 2
6
Control Group
6
9 on a numeric scale (from 0 to 10)
Group
Value
95% CI
Experimental Group 1
25
Experimental Group 2
15
Control Group
20
10 on a numeric scale (from 0 to 10)
Group
Value
95% CI
Experimental Group 1
28
Experimental Group 2
41
Control Group
38
no Data
Group
Value
95% CI
Experimental Group 1
6
Experimental Group 2
2
Control Group
0
Assess Compliance.Secondary· at the Day 1, 2 and 3
Rate of completion questionnaire (on the application) for the patient of arm "experimental group 1" (PRO (Patient Reported Outcomes) gathered via a phone consultation). ony this arm is analysed on this secondary objective.
indeed the objective is to evaluate compliance with an e-Health application
completion questionnaire at Day 1
Group
Value
95% CI
Experimental Group 1
60
completion questionnaire at Day 2
Group
Value
95% CI
Experimental Group 1
60
completion questionnaire at DAy 3
Group
Value
95% CI
Experimental Group 1
59
Assess Compliance.Secondary· At the Day 3
numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfaction).
no response 1, 2, 3, 4, 5 and 6
satisfy Score 7 on a numeric scale
Group
Value
95% CI
Experimental Group 1
2
Experimental Group 2
1
Control Group
1
satisfy Score 8 on a numeric scale
Group
Value
95% CI
Experimental Group 1
2
Experimental Group 2
6
Control Group
6
satisfy Score 9 on a numeric scale
Group
Value
95% CI
Experimental Group 1
25
Experimental Group 2
15
Control Group
20
satisfy Score 10 on a numeric scale
Group
Value
95% CI
Experimental Group 1
28
Experimental Group 2
41
Control Group
38
No data
Group
Value
95% CI
Experimental Group 1
6
Experimental Group 2
2
Control Group
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From randomization ti Day 10 post Biopsy.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Each year, approximately 1500 breast biopsies (1000 microbiopsies and 500 macrobiopsies) are performed in the radiologic department of the Montpellier Cancer Institute (ICM). This exam, which is relatively easy for the radiologist, can however lead to major anxiety for patients. Indeed, previous studies show that about 50% of women undergoing a breast biopsy have significant anxiety affects.
Anxiety associated with the risks of biopsy, potential breast cancer diagnosis and/or lack of routine sedation procedures increase patient concerns. Distress prior to biopsy is associated with greater pain and discomfort during the procedure. The psychological distress that persists after the biopsy is related to a worse psychological management of side effects of the biopsy breast (e.g., sensitivity, skin irritation).
Limiting apprehension, worry and anxiety induced by the uncertainty linked to the biopsy results and the biopsy-related pain should be an integral part of the medical care through the patient follow-up during, after and until the diagnosis is announced. In light of these challenges, new alternative methods are emerging to enhance patient knowledge, develop procedural skills, improve confidence and mitigate procedural anxiety. However, to our knowledge, few methods have been developed during this period of 'waiting-time'. Currently, only care instructions and a consultation to announce the results (about 10 days after the procedure) are proposed to patients at the end of biopsy. Patients are also encouraged to call if they suspect complications such as infection or bleeding.
In this context, the investigators propose to integrate a pain management after biopsy via e-health system through the patient's medical care. Radiologist/patient communication could have an impact on patients' anxiety and health-related issues, given the challenging nature of discussions around need for breast biopsy and potential implications of the results. Indeed, paying attention and focusing on symptoms as patients experience them improves their empowerment and their adjustment to the disease.
Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control and to enhance patient-clinician communication patient satisfaction, as well as well-being. In addition, it is known that improved communication between patients and medical staff to less anxiety after a biopsy and that anxiety is related to pain.
Taken as a whole, these elements encourage the integration of e-health and e-PRO for the management of pain and anxiety in patients undergoing a biopsy. The benefits of e-PRO are still being discussed in terms of quality of life (Qol) and psychological distress. The investigator propose to integrate two types of e-health intervention: 1/e-PRO collected by connected objects (smartphone or tablet) as they were used in previous studies, and 2/ e-PRO collected by a phone consultation, which values human communication between the medical staff and the patient.
In case of significant pain, the collection of e-PRO by any of these e-health interventions will generate an alert and a reactive and responsive care.
In fine, the purpose of this research is to improve the medical organization and care of post-biopsy patients by proposing an innovative connected patient technology, regardless of their remoteness from the hospital.
Social inequalities will be reduced by lending a tablet to patients who do not have such a device with a 4G key.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Institut du Cancer de Montpellier - Val d'Aurelle
Last refreshed: 2 December 2025
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