Biopsy Wound, Breast Cancer
Conditions
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.
Detailed description
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
Interventions
OTHERphone consultation
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.
OTHERe-PRO self-completed via connected objects (tablet/phone)
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
OTHERvisit
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.
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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 | 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 |
| 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 | 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) |
| 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 | 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 |
| 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 | Insomnia score assessed using the Index of Severity of Insomnia (from 0 "no insomnia" to 28 "maximal insomnia") administered at 10 days 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 | 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. |
| 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. | 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. |
| 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. | 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 |
| Assess Satisfaction With Specific Study Management. | 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. |
| Assess Compliance. | 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 |
Countries
France
Contacts
STUDY_CHAIRNougaret Stéphanie, MD
Institut du Cancer de Montpellier - Val d'Aurelle
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group 1 PRO (Patient Reported Outcomes) gathered via a phone consultation
phone consultation: 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 and concomitant treatment taken will be collected. If detected, pain or significative distress would be specifically managed.
phone consultation: At D4 post biopsy, patients 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 (+/- 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 and concomitant treatment taken will be collected. Insomnia will be evaluated by the Insomnia Severity Index. If detected, pain or significative distress would be managed as usually in the center. | 63 |
| Experimental Group 2 e-PRO self-completed via connected objects (tablet/phone)
e-PRO self-completed via connected objects (tablet/phone): 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 concomitant treatment taken. If detected, pain or significative distress would be specifically managed
phone consultation: 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 (+/- 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 and concomitant treatment taken will be collected. Insomnia will be evaluated by the Insomnia Severity Index. If detected, pain or significative distress would be managed as usually in the center. | 65 |
| Control Group group without e-PROs (standard care) | 65 |
| Total | 193 |
Baseline characteristics
| Characteristic | Experimental Group 1 | Total | Control Group | Experimental Group 2 |
|---|---|---|---|---|
| ACR Grade 3 of ACR (American College of Radiology) better outcome | 0 participants | 5 participants | 2 participants | 3 participants |
| ACR Grade 4-5 of ACR (American College of Radiology worse outcomes | 63 participants | 188 participants | 63 participants | 62 participants |
| Age, Continuous | 52 years | 54 years | 56 years | 55 years |
| Pain at the baseline Pain Score < 4 on a numeric pain scale (from 0 to 10) | 50 participants | 152 participants | 51 participants | 51 participants |
| Pain at the baseline Pain Score >= 4 on a numeric pain scale (from 0 to 10) | 13 participants | 41 participants | 14 participants | 14 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Sex: Female, Male Female | 63 Participants | 193 Participants | 65 Participants | 65 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Type of biopsy Macrobiopsy | 42 Participants | 127 Participants | 42 Participants | 43 Participants |
| Type of biopsy Microbiopsy | 21 Participants | 66 Participants | 23 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 44 / 63 | 27 / 65 | 31 / 65 |
| serious Total, serious adverse events | 0 / 63 | 0 / 65 | 0 / 65 |
Outcome results
Primary
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).
Time frame: From date of randomization until the Day 4 post biopsy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group 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 | Intense pain Score (6 to 7) on a a numeric pain scale | 0 participants |
| Experimental Group 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 | No pain (0) on a a numeric pain scale | 39 participants |
| Experimental Group 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 | Low pain score (1 to 3) on a a numeric pain scale | 19 participants |
| Experimental Group 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 | Moderate pain Score (4 to 5) on a a numeric pain scale | 0 participants |
| Experimental Group 2 | 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 | Intense pain Score (6 to 7) on a a numeric pain scale | 0 participants |
| Experimental Group 2 | 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 | Low pain score (1 to 3) on a a numeric pain scale | 17 participants |
| Experimental Group 2 | 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 | No pain (0) on a a numeric pain scale | 43 participants |
| Experimental Group 2 | 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 | Moderate pain Score (4 to 5) on a a numeric pain scale | 1 participants |
| Control Group | 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 | Low pain score (1 to 3) on a a numeric pain scale | 22 participants |
| Control Group | 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 | Moderate pain Score (4 to 5) on a a numeric pain scale | 1 participants |
| Control Group | 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 | Intense pain Score (6 to 7) on a a numeric pain scale | 1 participants |
| Control Group | 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 | No pain (0) on a a numeric pain scale | 36 participants |
Secondary
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
Time frame: From date of randomization until the Day 4 and the Day 10 post biopsy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group 1 | 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. | Infection | 0 participants |
| Experimental Group 1 | 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. | no bleeding | 63 participants |
| Experimental Group 1 | 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. | Bleeding | 0 participants |
| Experimental Group 1 | 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. | no infection | 63 participants |
| Experimental Group 2 | 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. | no bleeding | 64 participants |
| Experimental Group 2 | 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. | Infection | 0 participants |
| Experimental Group 2 | 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. | no infection | 65 participants |
| Experimental Group 2 | 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. | Bleeding | 1 participants |
| Control Group | 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. | no infection | 65 participants |
| Control Group | 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. | no bleeding | 64 participants |
| Control Group | 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. | Infection | 0 participants |
| Control Group | 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. | Bleeding | 1 participants |
Secondary
Assess Compliance.
numeric scale (likert scala : (from 0 no satisfy to 10 maximal satisfaction). no response 1, 2, 3, 4, 5 and 6
Time frame: At the Day 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group 1 | Assess Compliance. | satisfy Score 7 on a numeric scale | 2 participants |
| Experimental Group 1 | Assess Compliance. | satisfy Score 8 on a numeric scale | 2 participants |
| Experimental Group 1 | Assess Compliance. | satisfy Score 9 on a numeric scale | 25 participants |
| Experimental Group 1 | Assess Compliance. | satisfy Score 10 on a numeric scale | 28 participants |
| Experimental Group 1 | Assess Compliance. | No data | 6 participants |
| Experimental Group 2 | Assess Compliance. | satisfy Score 10 on a numeric scale | 41 participants |
| Experimental Group 2 | Assess Compliance. | satisfy Score 9 on a numeric scale | 15 participants |
| Experimental Group 2 | Assess Compliance. | No data | 2 participants |
| Experimental Group 2 | Assess Compliance. | satisfy Score 7 on a numeric scale | 1 participants |
| Experimental Group 2 | Assess Compliance. | satisfy Score 8 on a numeric scale | 6 participants |
| Control Group | Assess Compliance. | satisfy Score 7 on a numeric scale | 1 participants |
| Control Group | Assess Compliance. | satisfy Score 8 on a numeric scale | 6 participants |
| Control Group | Assess Compliance. | satisfy Score 10 on a numeric scale | 38 participants |
| Control Group | Assess Compliance. | No data | 0 participants |
| Control Group | Assess Compliance. | satisfy Score 9 on a numeric scale | 20 participants |
Secondary
Assess Compliance.
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
Time frame: at the Day 1, 2 and 3
Population: only arm experimental group 1 (PRO (Patient Reported Outcomes) gathered via a phone consultation) is analysed on this secondary objective other arms don't use ePRO. So this objective is only for 63 patient
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group 1 | Assess Compliance. | completion questionnaire at Day 2 | 60 participants |
| Experimental Group 1 | Assess Compliance. | completion questionnaire at Day 1 | 60 participants |
| Experimental Group 1 | Assess Compliance. | completion questionnaire at DAy 3 | 59 participants |
Secondary
Assess Satisfaction With Specific Study Management.
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.
Time frame: at the Day 10 post biopsy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group 1 | Assess Satisfaction With Specific Study Management. | 10 on a numeric scale (from 0 to 10) | 28 participants |
| Experimental Group 1 | Assess Satisfaction With Specific Study Management. | 9 on a numeric scale (from 0 to 10) | 25 participants |
| Experimental Group 1 | Assess Satisfaction With Specific Study Management. | 7 on a numeric scale (from 0 to 10) | 2 participants |
| Experimental Group 1 | Assess Satisfaction With Specific Study Management. | 8 on a numeric scale (from 0 to 10) | 2 participants |
| Experimental Group 1 | Assess Satisfaction With Specific Study Management. | no Data | 6 participants |
| Experimental Group 2 | Assess Satisfaction With Specific Study Management. | 9 on a numeric scale (from 0 to 10) | 15 participants |
| Experimental Group 2 | Assess Satisfaction With Specific Study Management. | 7 on a numeric scale (from 0 to 10) | 1 participants |
| Experimental Group 2 | Assess Satisfaction With Specific Study Management. | 8 on a numeric scale (from 0 to 10) | 6 participants |
| Experimental Group 2 | Assess Satisfaction With Specific Study Management. | 10 on a numeric scale (from 0 to 10) | 41 participants |
| Experimental Group 2 | Assess Satisfaction With Specific Study Management. | no Data | 2 participants |
| Control Group | Assess Satisfaction With Specific Study Management. | no Data | 0 participants |
| Control Group | Assess Satisfaction With Specific Study Management. | 10 on a numeric scale (from 0 to 10) | 38 participants |
| Control Group | Assess Satisfaction With Specific Study Management. | 7 on a numeric scale (from 0 to 10) | 1 participants |
| Control Group | Assess Satisfaction With Specific Study Management. | 9 on a numeric scale (from 0 to 10) | 20 participants |
| Control Group | Assess Satisfaction With Specific Study Management. | 8 on a numeric scale (from 0 to 10) | 6 participants |
Secondary
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
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).
Time frame: From date of randomization until the Day 10 post biopsy
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental 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 up | Pain score (0,10) at J0 on a numeric pain scale | 1 score on a scale |
| Experimental 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 up | Pain score (0,10) at J10 on a numeric pain scale | 0 score on a scale |
| Experimental Group 2 | 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 | Pain score (0,10) at J0 on a numeric pain scale | 1 score on a scale |
| Experimental Group 2 | 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 | Pain score (0,10) at J10 on a numeric pain scale | 0 score on a scale |
| Control Group | 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 | Pain score (0,10) at J0 on a numeric pain scale | 1 score on a scale |
| Control Group | 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 | Pain score (0,10) at J10 on a numeric pain scale | 0 score on a scale |
Secondary
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.
Insomnia score assessed using the Index of Severity of Insomnia (from 0 no insomnia to 28 maximal insomnia) administered at 10 days post biopsy
Time frame: From date of randomization until the Day 10 post biopsy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1 | 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. | Insomnia score (0 to 28) at J0 | 7.88 score on a scale | Standard Deviation 5.9 |
| Experimental Group 1 | 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. | Insomnia score (0 to 28) at J10 | 7.43 score on a scale | Standard Deviation 6.43 |
| Experimental Group 2 | 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. | Insomnia score (0 to 28) at J0 | 7.42 score on a scale | Standard Deviation 5.97 |
| Experimental Group 2 | 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. | Insomnia score (0 to 28) at J10 | 6.65 score on a scale | Standard Deviation 5.95 |
| Control Group | 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. | Insomnia score (0 to 28) at J10 | 7.34 score on a scale | Standard Deviation 5.91 |
| Control Group | 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. | Insomnia score (0 to 28) at J0 | 7.22 score on a scale | Standard Deviation 5.57 |
Secondary
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.
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
Time frame: From date of randomization until the Day 4 / Day 10 post biopsy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1 | 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. | Pain score (from 0 to 10) Day 10 post biopsy on a numeric pain scale | 0.75 score on a scale | Standard Deviation 1.35 |
| Experimental Group 1 | 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. | Pain score (from 0 to 10) Day 4 post biopsy on a numeric pain scale | 0.47 score on a scale | Standard Deviation 0.78 |
| Experimental Group 1 | 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. | Pain score (from 0 to10) at biopsy day on a numeric pain scale | 2.08 score on a scale | Standard Deviation 2.5 |
| Experimental Group 2 | 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. | Pain score (from 0 to 10) Day 10 post biopsy on a numeric pain scale | 0.54 score on a scale | Standard Deviation 1.1 |
| Experimental Group 2 | 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. | Pain score (from 0 to10) at biopsy day on a numeric pain scale | 1.98 score on a scale | Standard Deviation 2.21 |
| Experimental Group 2 | 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. | Pain score (from 0 to 10) Day 4 post biopsy on a numeric pain scale | 0.54 score on a scale | Standard Deviation 1.03 |
| Control Group | 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. | Pain score (from 0 to 10) Day 4 post biopsy on a numeric pain scale | 0.65 score on a scale | Standard Deviation 1.12 |
| Control Group | 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. | Pain score (from 0 to10) at biopsy day on a numeric pain scale | 1.86 score on a scale | Standard Deviation 1.78 |
| Control Group | 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. | Pain score (from 0 to 10) Day 10 post biopsy on a numeric pain scale | 0.54 score on a scale | Standard Deviation 0.99 |
Secondary
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.
Time frame: From date of randomization until the Day 4 and the Day 10 post biopsy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group 1 | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | No phone call | 0 participants |
| Experimental Group 1 | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | Phone call | 60 participants |
| Experimental Group 1 | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | No data | 3 participants |
| Experimental Group 2 | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | No phone call | 1 participants |
| Experimental Group 2 | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | Phone call | 62 participants |
| Experimental Group 2 | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | No data | 2 participants |
| Control Group | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | Phone call | 62 participants |
| Control Group | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | No data | 3 participants |
| Control Group | the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management | No phone call | 0 participants |
Secondary
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.
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)
Time frame: From date of randomization until the Day 4 and Day 10 post biopsy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1 | 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. | Anxiety score (0,10) at J4 a numeric anxiety scale | 1.88 score on a scale | Standard Deviation 1.63 |
| Experimental Group 1 | 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. | Anxiety score (0,10) at J0 on a numeric anxiety scale | 4.52 score on a scale | Standard Deviation 3.02 |
| Experimental Group 1 | 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. | Anxiety score (0,10) at J10 a numeric anxiety scale | 3.43 score on a scale | Standard Deviation 3.02 |
| Experimental Group 2 | 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. | Anxiety score (0,10) at J4 a numeric anxiety scale | 2.51 score on a scale | Standard Deviation 2.75 |
| Experimental Group 2 | 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. | Anxiety score (0,10) at J0 on a numeric anxiety scale | 4.12 score on a scale | Standard Deviation 3.31 |
| Experimental Group 2 | 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. | Anxiety score (0,10) at J10 a numeric anxiety scale | 3.83 score on a scale | Standard Deviation 3 |
| Control Group | 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. | Anxiety score (0,10) at J0 on a numeric anxiety scale | 4.57 score on a scale | Standard Deviation 3.27 |
| Control Group | 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. | Anxiety score (0,10) at J10 a numeric anxiety scale | 4.65 score on a scale | Standard Deviation 3.19 |
| Control Group | 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. | Anxiety score (0,10) at J4 a numeric anxiety scale | 3.80 score on a scale | Standard Deviation 2.5 |
Secondary
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
Time frame: From date of randomization until the Day 4 and Day 10 post biopsy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1 | 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 (0-100) at J4 on a numeric scale | 7.69 score on a scale | Standard Deviation 19 |
| Experimental Group 1 | 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 (0-100) at J0 on a numeric scale | 4.29 score on a scale | Standard Deviation 10.88 |
| Experimental Group 1 | 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 (0-100) at J10 on a numeric scale | 8.69 score on a scale | Standard Deviation 17.08 |
| Experimental Group 2 | 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 (0-100) at J4 on a numeric scale | 10.05 score on a scale | Standard Deviation 21.77 |
| Experimental Group 2 | 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 (0-100) at J0 on a numeric scale | 4.06 score on a scale | Standard Deviation 8.49 |
| Experimental Group 2 | 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 (0-100) at J10 on a numeric scale | 8.54 score on a scale | Standard Deviation 15.91 |
| Control Group | 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 (0-100) at J0 on a numeric scale | 6.41 score on a scale | Standard Deviation 12.77 |
| Control Group | 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 (0-100) at J10 on a numeric scale | 3.08 score on a scale | Standard Deviation 5.84 |
| Control Group | 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 (0-100) at J4 on a numeric scale | 4.18 score on a scale | Standard Deviation 8.43 |
Secondary
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.
Time frame: From date of randomization until the Day 4 and Day 10 post biopsy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group 1 | 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. | No data | 0 participants |
| Experimental Group 1 | 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. | No concomitant treatment | 40 participants |
| Experimental Group 1 | 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. | concomitant treatment | 23 participants |
| Experimental Group 2 | 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. | No data | 1 participants |
| Experimental Group 2 | 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. | concomitant treatment | 28 participants |
| Experimental Group 2 | 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. | No concomitant treatment | 36 participants |
| Control Group | 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. | No data | 0 participants |
| Control Group | 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. | No concomitant treatment | 38 participants |
| Control Group | 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. | concomitant treatment | 27 participants |