Pain Monitoring After Breast Biopsy: Benefit of E-health

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary objective is 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. This study is a Monocentric, prospective, open-labeled, randomized controlled trial. A total of 192 patients (64 patients in group control vs 64 patients in experimental group 1 (PRO gathered via a phone consultation) and 64 patients in experimental group 2 (e-PRO self-completed via connected objects (tablet/phone) will be required including 10% of lost-to-follow-up patients. The inclusion period would be 8 months

Official Title
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Pain Monitoring After Breast Biopsy: Benefit of E-health

Conditions
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Breast Cancer, Biopsy Wound

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


Participation Criteria
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Eligibility Criteria
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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 Exclusion 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group 1<br>PRO (Patient Reported Outcomes) gathered via a phone consultation | Other: phone consultation<br>* 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.<br>Other: phone consultation<br>* 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.<br>Other: visit<br>* 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.<br>|
| Experimental: Experimental group 2<br>e-PRO self-completed via connected objects (tablet/phone) | Other: e-PRO self-completed via connected objects (tablet/phone)<br>* 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<br>Other: phone consultation<br>* 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.<br>Other: visit<br>* 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.<br>|
| No Intervention: Control group<br>group without e-PROs (standard care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Day 10) after a breast 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). | 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 and 10 days (Day 4, Day 10) after a breast 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 | 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 and 10 days (Day 4, Day 10) after a breast 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) | 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 anxiety intensity of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy. | Anxiety score assessed using a numeric anxiety scale (from 0 no anxiety to 10 maximal anxiety) administered after to biopsy, at 4 days and 10 days post 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. | 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 | 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 esthetic impact of patients at 4 and 10 days (Day 4, Day 10) after a breast 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 | 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 insomnia of patients at 4 and 10 days after a breast biopsy. | Insomnia score assessed using the Index of Severity of Insomnia administered (from 0 no insomnia to 28 maximal insomnia) during the baseline visit and the consultation of results announcement. | 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 insomnia of patients at 4 days (Day 4) and at 10 days (about Day 10), after a breast 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 | From date of randomization until the 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 patient's management | Number of alerts that generated a phone call or number of phone calls generated directly by the patient and patient care accordingly. | From date of randomization until the Day 4 and the Day 10 post biopsy | 
| 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. | Quantity, nature and dose of treatments used for the biopsy and its aftermath. | From date of randomization until the Day 4 and Day 10 post biopsy | 
| 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. | 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 | From date of randomization until the Day 4 and the Day 10 post biopsy | 
| assess satisfaction with specific study management. | Number of positive responses to satisfaction questions related to the number of solicitations for the study and how interventions are communicated | From date of randomization until the Day 4 and the Day 10 post biopsy | 
| assess compliance. | Rate of completion questionnaire (on the application) | From date of randomization until the Day 3 | 
| assess compliance. | numeric scale (likert scala : (from 0 no satisfy to 10 maximal satisfy) | From date of randomization until the Day 3 |