Pain Monitoring After Breast Biopsy: Benefit of E-health
Phase: NA
Conditions: Breast Cancer, Biopsy Wound
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

 
 
 
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SYNOPSIS (English) 
Title 
Pain monitoring after breast biopsy: benefit of e-health 
Acronym 
BIO-PSY 
Pathology 
Breast cancer 
Protocol 
codes 
Sponsor Code : PRO ICM 2020-06 BIO 
ID-RCB: 2020-A00836-33 
N° NCT : NCT04456920 
Study Sponsor Institut régional du Cancer de Montpellier - ICM 
Clinical Research and Innovation Department (DRCI) 
208 rue des Apothicaires 
34298 Montpellier Cedex 05 – France  
Contact Name : Mme Aurore MOUSSION 
Mail      : DRCI-icm105@icm.unicancer.fr 
Phone  : +33 4 67 61 31 02 
Fax       : +33 4 67 41 30 23 
Clinical trial 
coordinators  
Dr Stephanie NOUGARET 
ICM 
Department of Radiology 
Phone : +33 4 67 61 47 25 
E-mail : stephanie.nougaret@icm.unicancer.fr 
 
Clinical trial co-coordinator :  
Dr Estelle GUERDOUX, Ph.D 
ICM 
Department of Supportive Care 
Phone : +33 4 67 61 24 68 
E-mail : estelle.guerdoux@icm.unicancer.fr 
Methodology 
and data 
management 
Center  
Institut régional du Cancer de Montpellier - ICM 
Biometrics Unit  
Contact : Mme Sophie GOURGOU 
Phone : 04 67 61 37 75 
E-mail : Sophie.gourgou@icm.unicancer.fr 
Project 
manager 
Institut régional du Cancer de Montpellier - ICM 
DRCI - Promotion Unit 
Contacts : Mrs Laetitia MEIGNANT 
Phone : +33 4 67 61 47 38 
E-mail : laetitia.meignant@icm.unicancer.fr 
Study design 
Monocentric, prospective, open-labeled, randomized controlled trial 
Trial sites 
1 participating center 
Number of 
planned 
patients 
Expected number of patients : 192 

 
 
 
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Background 
and Rationale 
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, we 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. We thus 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. 

 
 
 
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Study 
Objective(s) 
Primary objective 
To compare the benefit of intervention by e-health (phone consultation with a 
professional or connected objects (smartphone or tablet)) with the standard follow 
up of the pain intensity of patients 4 days (D4) after un breast biopsy. 
 
Secondary objectives 
- To compare the benefit of intervention by e-health (phone consultation with a 
professional or connected objects) with the standard follow up of the pain 
intensity of patients during the consultation of results announcement (about D10) 
after a breast biopsy. 
- To compare 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 
(about D10), after a breast biopsy. 
- To compare 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 (D4) and during the consultation of results 
announcement (about D10), after a breast biopsy. 
- To compare the benefit according to the type of intervention by e-health (phone 
consultation with a professional or connected objects) on the anxiety intensity of 
patients at 4 days (D4) and during the consultation of results announcement 
(about D10), after a breast biopsy. 
- To compare 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 days (D4) and during the consultation of results 
announcement (about D10), after a breast biopsy. 
- To compare the benefit according to the type of intervention by e-health (phone 
consultation with a professional or connected objects) on the esthetic impact of 
patients at 4 days (D4) and during the consultation of results announcement 
(about D10), after a breast biopsy. 
- To compare the benefit of intervention by e-health (phone consultation with a 
professional or connected objects with the standard follow up of the insomnia of 
patients at 4 days (D4) and during the consultation of results announcement 
(about D10), after a breast biopsy. 
- To compare 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 4 days (D4) and during the consultation of results announcement 
(about D10), after a breast biopsy. 
- To compare the benefit of intervention by e-health (phone consultation with a 
professional or connected objects) with the standard follow up of patient’s 
management 
- To compare the use of a biopsy-related drug intervention (analgesics, anxiolytics, 
antidepressants, anti-inflammatory and hypnotics) in patients with e-health 
interventions (phone consultation or smartphone), with the standard follow-up, 
during the consultation of results announcement (about D10) after a breast 
biopsy.  
- To compare 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. 

 
 
 
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- To reduce social and territorial inequalities. 
- To assess satisfaction with specific study management. 
- To assess compliance. 
Study 
endpoints  
 
Primary endpoint:  
Pain score assessed (by phone) via a numeric pain scale completed 4 days after 
biopsy (D4). 
 
Secondary endpoints : 
- 
Pain score assessed using a numeric pain scale administered after to 
biopsy and during the consultation of results announcement (approximately 
D10). 
- 
Anxiety score assessed using a numeric anxiety scale administered after to 
biopsy, at 4 days (D4) and during the consultation of results announcement 
(approximately D10). 
- 
Esthetic impact score assessed using a numeric esthetic scale administered 
after to biopsy, at 4 days (D4) and during the consultation of results 
announcement (approximately D10). 
- 
Insomnia score assessed using the Index of Severity of Insomnia 
administered during the baseline visit and the consultation of results 
announcement (approximately D10). 
- 
Number of alerts that generated a phone call or number of phone calls 
generated directly by the patient and patient care accordingly. 
- 
Quantity, nature and dose of analgesics, anxiolytics, anti-depressants, anti-
inflammatory and hypnotics used for the biopsy and its aftermath. 
- 
Adverse event in particular bleeding and infection due to biopsy recorded at 
4 days (D4) and during the consultation of results announcement (about 
D10) by NCI-CTCAE 5.0 
- 
Geographical distance from the reference center.  
- 
Number of tablets/4G keys made available to patients who do not benefit 
from them at home.  
- 
Number of positive responses to satisfaction questions related to the 
number of solicitations for the study and how interventions are 
communicated  
- 
Rate of completion questionnaire and numeric scale. 
Benefit  
 
Focusing on symptoms as patients experience them improves their empowerment 
and their adjustment to the disease.  
e-PRO 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, all these elements encourage to integrate e-health and e-PRO 
in the management of pain and anxiety in patients undergoing a biopsy.  
In case of significant pain, the gathered e-PRO will generate an alert and a reactive 
and responsive care. In fine, this research aims to improve the medical 
organization and management of post-biopsy patients by proposing an innovative 
connected patient technology, regardless of their remoteness from the hospital. 

 
 
 
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Eligibility 
criteria 
1) Inclusion criteria 
- Patient with diagnostic breast biopsy at ICM 
- Age > 18 years 
- Informed patient and signed informed consent received   
- Affiliation to a social security system 
 
2) Non inclusion criteria 
- Patient without phone number 
- Patient with previous biopsy in 6 months prior to study 
- Pregnant and breastfeeding woman 
- Patient whose regular follow-up is initially impossible for psychological, family, 
social or geographical reasons 
- Patient under legal protection (guardianship, curatorship or safeguarding of 
justice) 
Enrolment 
Procedure 
After the patient has given her informed consent to participate in the study, and 
after verification of all inclusion/ non-inclusion criteria, the investigator will proceed 
to the patient registration via a dedicated form to be sent to the Biometrics Unit of 
the center. 
Treatment 
modalities 
After breast biopsy and randomization (random bloc method and ratio 1:1:1), 
patients will either be in the:  
   - 
Experimental 
Group 
1: 
PRO 
gathered 
via 
a 
phone 
consultation 
   - Experimental Group 2:  e-PRO self-completed via connected objects 
(tablet/phone)  
   - Group 3: Control group without e-PROs (standard care) 
 
 
 
 

 
 
 
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At D1, D2 and D3, patients in the experimental group 1 will receive a call from a 
neuro-psychologist during which pain, anxiety and esthetical biopsy impact will be 
assessed using numeric or visual analog scales during a semi-direct interview. 
During this call, any adverse events related to the breast biopsy will also be noted, 
as well as the amount, nature and dose of analgesics, anxiolytics, anti-
depressants, anti-inflammatory and hypnotics taken linked to the biopsy.  If 
detected, pain or significative distress would be specifically managed. 
 
Patients in the experimental group 2 will be asked by SMS or notification to 
connect to the application in order to complete online the numeric and visual anog 
scales of pain, anxiety and esthetical impact. Any adverse events related to the 
breast biopsy will also be noted online, as well as the amount, nature and dose of 
analgesics, anxiolytics, anti-depressants, anti-inflammatory and hypnotics taken for 
the biopsy. If detected, pain or significative distress would be specifically managed. 
 
At D4 post biopsy, all patients (of the 3 groups) will receive a phone call from a 
neuro-psychologist to assess pain, anxiety and esthetical impact, using numeric 
scales, and to collect adverse events. If detected, pain or significative distress 
would be specifically managed. 
 
And at D10 (+/- 3 days), all patients will have the consultation of biopsy results 
announcement. This visit will be held either on-site or by videoconference At the 
beginning of this consultation, pain, anxiety and esthetical impact will be assessed 
using numeric scales. The adverse events related to the breast biopsy will be 
collected as well as the amount, nature and dose of analgesics, anxiolytics, anti-
depressants, anti-inflammatory and hypnotics taken for the biopsy and its findings. 
Insomnia will be evaluated by the Insomnia Severity Index. If detected, pain or 
significative distress would be managed as usually in the center. 
If the consultation is to be done by telephone, it is essential that this data collection 
be done before the results are announced. 
Statistical 
considerations 
Sample size. 
A pilot study has been performed in the radiology department including 25 patients 
in order to determine the pain level on average: mean = 5 and standard deviation = 
3. 
Assuming a mean pain score on day 4 equals to 5 points with a standard deviation 
equals to 3 in the control group, with  (two-sided) = 2.5%, power= 90%, it is 
necessary to include 58 patients per group (174 patients in total), to detect a 
difference of 
2 
points 
(according 
algology 
criteria 
and 
good 
practice 
recommendations) between control arm and each experimental arm. Finally, 192 
patients will be included considering 10% non-evaluable patients.  
 
Statistical analyses.  
A statistical analysis plan (SAP) will be written before the closed database. All 
statistical analyses will be performed on ITT population and on PP (per-protocole) 
population for primary endpoint. All collected data will be described.  
Descriptive analyses will be performed using frequency (N) and percentage (%) for 
categorical variables, mean / standard deviation or median / range for continuous 
parameters. 

 
 
 
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The Pearson’s chi-square or the Fisher’s exact test will be performed for 
categorical variables and the Student test or Wilcoxon / Kruskal-Wallis test for 
continuous parameters. 
 
The primary endpoint, pain score assessed by phone 4 days after biopsy, will be 
compared between control and experimental arms (telemedicine vs control and 
smartphone vs control). 
 
The secondary endpoints will be compared between control and experimental arms 
(telemedicine vs control and smartphone vs control) and between the two e-PRO 
interventions (telemedicine vs smartphone). 
 
All statistical analyses will be performed with the Stata software v16.0 and a 
statistical report will be provided according to the current model. 
Study period 
Starting date of inclusion: February 2021 
Duration of inclusion: 34 months 
Duration of participation: 10 days (+/- 2 days) 
Date of end of patient follow-up: December 2023