Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04456920
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2020-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pain Monitoring After Breast Biopsy: Benefit of E-health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drci-icm105@icm.unicancer.fr', 'phone': '0467613102', 'title': 'Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation', 'phoneExt': '+33', 'organization': 'INSTITUT REGIONAL DU CANCER DE MONTPELLIER'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From randomization ti Day 10 post Biopsy', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 44, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 27, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 31, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 49, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Esthetic Impact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthrophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'No pain (0) on a a numeric pain scale', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Low pain score (1 to 3) on a a numeric pain scale', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Moderate pain Score (4 to 5) on a a numeric pain scale', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Intense pain Score (6 to 7) on a a numeric pain scale', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the Day 4 post biopsy', 'description': '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).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'Pain score (0,10) at J0 on a numeric pain scale', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pain score (0,10) at J10 on a numeric pain scale', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the Day 10 post biopsy', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'Pain score (from 0 to10) at biopsy day on a numeric pain scale', 'categories': [{'measurements': [{'value': '2.08', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '1.86', 'spread': '1.78', 'groupId': 'OG002'}]}]}, {'title': 'Pain score (from 0 to 10) Day 4 post biopsy on a numeric pain scale', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': 'Pain score (from 0 to 10) Day 10 post biopsy on a numeric pain scale', 'categories': [{'measurements': [{'value': '0.75', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until the Day 4 / Day 10 post biopsy', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'Anxiety score (0,10) at J0 on a numeric anxiety scale', 'categories': [{'measurements': [{'value': '4.52', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '3.31', 'groupId': 'OG001'}, {'value': '4.57', 'spread': '3.27', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety score (0,10) at J4 a numeric anxiety scale', 'categories': [{'measurements': [{'value': '1.88', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '3.80', 'spread': '2.50', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety score (0,10) at J10 a numeric anxiety scale', 'categories': [{'measurements': [{'value': '3.43', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '3.00', 'groupId': 'OG001'}, {'value': '4.65', 'spread': '3.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until the Day 4 and Day 10 post biopsy', 'description': '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)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'Esthetic Impact (0-100) at J0 on a numeric scale', 'categories': [{'measurements': [{'value': '4.29', 'spread': '10.88', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '8.49', 'groupId': 'OG001'}, {'value': '6.41', 'spread': '12.77', 'groupId': 'OG002'}]}]}, {'title': 'Esthetic Impact (0-100) at J4 on a numeric scale', 'categories': [{'measurements': [{'value': '7.69', 'spread': '19.00', 'groupId': 'OG000'}, {'value': '10.05', 'spread': '21.77', 'groupId': 'OG001'}, {'value': '4.18', 'spread': '8.43', 'groupId': 'OG002'}]}]}, {'title': 'Esthetic Impact (0-100) at J10 on a numeric scale', 'categories': [{'measurements': [{'value': '8.69', 'spread': '17.08', 'groupId': 'OG000'}, {'value': '8.54', 'spread': '15.91', 'groupId': 'OG001'}, {'value': '3.08', 'spread': '5.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until the Day 4 and Day 10 post biopsy', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'Insomnia score (0 to 28) at J0', 'categories': [{'measurements': [{'value': '7.88', 'spread': '5.90', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '5.97', 'groupId': 'OG001'}, {'value': '7.22', 'spread': '5.57', 'groupId': 'OG002'}]}]}, {'title': 'Insomnia score (0 to 28) at J10', 'categories': [{'measurements': [{'value': '7.43', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '6.65', 'spread': '5.95', 'groupId': 'OG001'}, {'value': '7.34', 'spread': '5.91', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until the Day 10 post biopsy', 'description': 'Insomnia score assessed using the Index of Severity of Insomnia (from 0 "no insomnia" to 28 "maximal insomnia") administered at 10 days post biopsy', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management", 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'Phone call', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'No phone call', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'No data', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the Day 4 and the Day 10 post biopsy', 'description': 'Number of alerts that generated a phone call or number of phone calls generated directly by the patient and patient care accordingly.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'concomitant treatment', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'No concomitant treatment', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'No data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the Day 4 and Day 10 post biopsy', 'description': 'Quantity, nature and dose of treatments used for the biopsy and its aftermath.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'no bleeding', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'no infection', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the Day 4 and the Day 10 post biopsy', 'description': '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', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess Satisfaction With Specific Study Management.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO (Patient Reported Outcomes) self-completed via connected objects (tablet/phone)\n\ne-PRO (Patient Reported Outcomes) 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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (Patient Reported Outcomes) (standard care)'}], 'classes': [{'title': '7 on a numeric scale (from 0 to 10)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '8 on a numeric scale (from 0 to 10)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '9 on a numeric scale (from 0 to 10)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': '10 on a numeric scale (from 0 to 10)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'no Data', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the Day 10 post biopsy', 'description': '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.\n\nNo response 1, 2, 3, 4, 5, and 6 done.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess Compliance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}], 'classes': [{'title': 'completion questionnaire at Day 1', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'completion questionnaire at Day 2', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'completion questionnaire at DAy 3', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the Day 1, 2 and 3', 'description': '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.\n\nindeed the objective is to evaluate compliance with an e-Health application', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Assess Compliance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'classes': [{'title': 'satisfy Score 7 on a numeric scale', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'satisfy Score 8 on a numeric scale', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'satisfy Score 9 on a numeric scale', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'satisfy Score 10 on a numeric scale', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'No data', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the Day 3', 'description': 'numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfaction).\n\nno response 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nvisit: 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.'}, {'id': 'FG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation\n\nphone 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.\n\nphone 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.\n\nAnd 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.'}, {'id': 'BG001', 'title': 'Experimental Group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)\n\ne-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\n\nphone 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.\n\nAnd 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.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'group without e-PROs (standard care)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '85'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '82'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '81'}, {'value': '54', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Type of biopsy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Macrobiopsy', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}, {'title': 'Microbiopsy', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ACR', 'classes': [{'title': 'Grade 3 of ACR (American College of Radiology) better outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Grade 4-5 of ACR (American College of Radiology worse outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain at the baseline', 'classes': [{'title': 'Pain Score < 4 on a numeric pain scale (from 0 to 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}]}, {'title': 'Pain Score >= 4 on a numeric pain scale (from 0 to 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'patients were randomized to the following stratification factors:\n\n* Ultrasound-guided biopsy (Microbiopsies) versus stereotactic biopsy/MRI (macrobiopsies)\n* ACR3 vs. ACR 4-5\n* Pain \\< 4 versus 4 at inclusion'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-29', 'size': 563940, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-03T09:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2020-06-23', 'resultsFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-03', 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'From date of randomization until the Day 4 post biopsy', 'description': '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).'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'From date of randomization until the Day 10 post biopsy', 'description': '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).'}, {'measure': '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.', 'timeFrame': 'From date of randomization until the Day 4 / Day 10 post biopsy', 'description': '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'}, {'measure': '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.', 'timeFrame': 'From date of randomization until the Day 4 and Day 10 post biopsy', 'description': '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)'}, {'measure': '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.', 'timeFrame': 'From date of randomization until the Day 4 and Day 10 post biopsy', 'description': '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'}, {'measure': '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.', 'timeFrame': 'From date of randomization until the Day 10 post biopsy', 'description': 'Insomnia score assessed using the Index of Severity of Insomnia (from 0 "no insomnia" to 28 "maximal insomnia") administered at 10 days post biopsy'}, {'measure': "the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management", 'timeFrame': 'From date of randomization until the Day 4 and the Day 10 post biopsy', 'description': 'Number of alerts that generated a phone call or number of phone calls generated directly by the patient and patient care accordingly.'}, {'measure': '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.', 'timeFrame': 'From date of randomization until the Day 4 and Day 10 post biopsy', 'description': 'Quantity, nature and dose of treatments used for the biopsy and its aftermath.'}, {'measure': '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.', 'timeFrame': 'From date of randomization until the Day 4 and the Day 10 post biopsy', 'description': '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'}, {'measure': 'Assess Satisfaction With Specific Study Management.', 'timeFrame': 'at the Day 10 post biopsy', 'description': '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.\n\nNo response 1, 2, 3, 4, 5, and 6 done.'}, {'measure': 'Assess Compliance.', 'timeFrame': 'at the Day 1, 2 and 3', 'description': '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.\n\nindeed the objective is to evaluate compliance with an e-Health application'}, {'measure': 'Assess Compliance.', 'timeFrame': 'At the Day 3', 'description': 'numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfaction).\n\nno response 1, 2, 3, 4, 5 and 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Biopsy Wound']}, 'referencesModule': {'references': [{'pmid': '17723985', 'type': 'BACKGROUND', 'citation': "Pineault P. 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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.\n\nAnxiety 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).\n\nLimiting 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.\n\nIn 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.\n\nWeb-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.\n\nTaken 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.\n\nIn 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.\n\nIn 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.\n\nSocial inequalities will be reduced by lending a tablet to patients who do not have such a device with a 4G key.", 'detailedDescription': '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.\n\nThis 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.\n\nThe inclusion period would be 8 months'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with diagnostic breast biopsy at ICM\n* Age \\> 18 years\n* Informed patient and signed informed consent received\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Patient without phone number\n* Patient with previous biopsy in 6 months prior to study\n* Pregnant and breastfeeding woman\n* Patient whose regular follow-up is initially impossible for psychological, family, social or geographical reasons\n* Patient under legal protection (guardianship, curatorship or safeguarding of justice)'}, 'identificationModule': {'nctId': 'NCT04456920', 'acronym': 'BIO-PSY', 'briefTitle': 'Pain Monitoring After Breast Biopsy: Benefit of E-health', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Pain Monitoring After Breast Biopsy: Benefit of E-health', 'orgStudyIdInfo': {'id': 'PROICM 2020-06 BIO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group 1', 'description': 'PRO (Patient Reported Outcomes) gathered via a phone consultation', 'interventionNames': ['Other: phone consultation', 'Other: visit']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group 2', 'description': 'e-PRO self-completed via connected objects (tablet/phone)', 'interventionNames': ['Other: e-PRO self-completed via connected objects (tablet/phone)', 'Other: phone consultation', 'Other: visit']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'group without e-PROs (standard care)'}], 'interventions': [{'name': 'phone consultation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental group 1']}, {'name': 'e-PRO self-completed via connected objects (tablet/phone)', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Experimental group 2']}, {'name': 'phone consultation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental group 1', 'Experimental group 2']}, {'name': 'visit', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental group 1', 'Experimental group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'state': 'Hérault', 'country': 'France', 'facility': "Icm Val D'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Nougaret Stéphanie, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Institut du Cancer de Montpellier - Val d'Aurelle"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients All participant data collected during the trial, after encoding with an inclusion number, 1st letter of the name and surname may be shared.\n\nThe data of the participants will be available upon request and with the completion of a contract between the promoter and the applicant.\n\nThe study protocol, the statistical analysis plan (PAS) and the analytical code may also be subject to data sharing as part of a transfer contract (RGPD)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}