Pain Monitoring After Breast Biopsy: Benefit of E-health

NCT04456920 | Completed Results DMC

• 1 other identifier: PROICM 2020-06 BIO
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Biopsy Wound

Outcome Measures

Primary Outcomes (1)

• 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 up

  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).

  From date of randomization until the Day 4 post biopsy

Secondary Outcomes (11)

• 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 up

  From date of randomization until the Day 10 post biopsy

• 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.

  From date of randomization until the Day 4 / Day 10 post biopsy

• 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.

  From date of randomization until the Day 4 and Day 10 post biopsy

• 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.

  From date of randomization until the Day 4 and Day 10 post biopsy

• 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.

  From date of randomization until the Day 10 post biopsy

Study Arms (3)

Experimental group 1

EXPERIMENTAL

PRO (Patient Reported Outcomes) gathered via a phone consultation

Other: phone consultation; Other: visit

Experimental group 2

EXPERIMENTAL

e-PRO self-completed via connected objects (tablet/phone)

Other: e-PRO self-completed via connected objects (tablet/phone); Other: phone consultation; Other: visit

Control group

NO INTERVENTION

group without e-PROs (standard care)

Interventions

phone consultation OTHER

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.

Experimental group 1

e-PRO self-completed via connected objects (tablet/phone) OTHER

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

Experimental group 2

visit OTHER

And at D10 (+/- 2 days), all patients will physically come to the Cancer center in the consultation of biopsy results announcement. 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.

Experimental group 1; Experimental group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with diagnostic breast biopsy at ICM
• Age \> 18 years
• Informed patient and signed informed consent received
• Affiliation to a social security system

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Icm Val D'Aurelle

Montpellier, Hérault, 34298, France

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tablets

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation
• Organization: INSTITUT REGIONAL DU CANCER DE MONTPELLIER

drci-icm105@icm.unicancer.fr

0467613102

Study Officials

• Nougaret Stéphanie, MD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 7, 2020
• Study Start: February 9, 2021
• Primary Completion: November 20, 2023
• Study Completion: April 19, 2024
• Last Updated: December 2, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)