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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1 | Experimental | PRO (Patient Reported Outcomes) gathered via a phone consultation |
|
| Experimental group 2 | Experimental | e-PRO self-completed via connected objects (tablet/phone) |
|
| Control group | No Intervention | group without e-PROs (standard care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nougaret Stéphanie, MD | Institut du Cancer de Montpellier - Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icm Val D'Aurelle | Montpellier | Hérault | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17723985 | Background | Pineault P. Breast Cancer Screening: Women's Experiences of Waiting for Further Testing. Oncol Nurs Forum. 2007 Jul;34(4):847-53. doi: 10.1188/07.ONF.847-853. | |
| 11267855 | Background | Lampic C, Thurfjell E, Bergh J, Sjoden PO. Short- and long-term anxiety and depression in women recalled after breast cancer screening. Eur J Cancer. 2001 Mar;37(4):463-9. doi: 10.1016/s0959-8049(00)00426-3. |
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All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. visit: 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. |
| FG001 | 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. |
| FG002 | Control Group | group without e-PROs (standard care) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patients were randomized to the following stratification factors:
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | participants | From date of randomization until the Day 4 post biopsy |
|
From randomization ti Day 10 post Biopsy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PAIN | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation | INSTITUT REGIONAL DU CANCER DE MONTPELLIER | 0467613102 | +33 | drci-icm105@icm.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2023 | Mar 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| 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 |
|
| phone consultation | Other | 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. |
|
| 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. |
|
| 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. | 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 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) | 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 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 | 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 (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. | at the Day 10 post biopsy |
| 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 | at the Day 1, 2 and 3 |
| Assess Compliance. | numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfaction). no response 1, 2, 3, 4, 5 and 6 | At the Day 3 |
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| BG001 | 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. |
| BG002 | Control Group | group without e-PROs (standard care) |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type of biopsy | Count of Participants | Participants |
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| ACR | Number | participants |
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| Pain at the baseline | Number | participants |
|
| OG001 | 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. |
| OG002 | Control Group | group without e-PROs (standard care) |
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| 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). | Posted | Median | Full Range | score on a scale | From date of randomization until the Day 10 post biopsy |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | From date of randomization until the Day 4 / Day 10 post biopsy |
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| 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) | Posted | Mean | Standard Deviation | score on a scale | From date of randomization until the Day 4 and Day 10 post biopsy |
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|
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| 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 | Posted | Mean | Standard Deviation | score on a scale | From date of randomization until the Day 4 and Day 10 post biopsy |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | From date of randomization until the Day 10 post biopsy |
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| 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. | Posted | Number | participants | From date of randomization until the Day 4 and the Day 10 post biopsy |
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| 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. | Posted | Number | participants | From date of randomization until the Day 4 and Day 10 post biopsy |
|
|
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| 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 | Posted | Number | participants | From date of randomization until the Day 4 and the Day 10 post biopsy |
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|
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| 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. | Posted | Number | participants | at the Day 10 post biopsy |
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| 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 | 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 | Posted | Number | participants | at the Day 1, 2 and 3 |
|
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| Secondary | Assess Compliance. | numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfaction). no response 1, 2, 3, 4, 5 and 6 | Posted | Number | participants | At the Day 3 |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 44 |
| 63 |
| EG001 | 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. | 0 | 65 | 0 | 65 | 27 | 65 |
| EG002 | Control Group | group without e-PROs (standard care) | 0 | 65 | 0 | 65 | 31 | 65 |
| Anxiety | General disorders | Non-systematic Assessment |
|
| Esthetic Impact | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Arthrophlebitis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hematome | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Irritation | General disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Male |
|
| Microbiopsy |
|
|
|
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| Pain score (from 0 to 10) Day 10 post biopsy on a numeric pain scale |
|
|
| Anxiety score (0,10) at J10 a numeric anxiety scale |
|
|
| Esthetic Impact (0-100) at J10 on a numeric scale |
|
|
| Title | Measurements |
|---|---|
|
| No data |
|
|
| No data |
|
| Title | Measurements |
|---|---|
|
| Infection |
|
| no infection |
|
|
| 9 on a numeric scale (from 0 to 10) |
|
| 10 on a numeric scale (from 0 to 10) |
|
| no Data |
|
| Title | Measurements |
|---|---|
|
|
| satisfy Score 9 on a numeric scale |
|
| satisfy Score 10 on a numeric scale |
|
| No data |
|