Trial Outcomes & Findings for Pain Monitoring After Breast Biopsy: Benefit of E-health (NCT NCT04456920)
NCT ID: NCT04456920
Last Updated: 2025-12-02
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
193 participants
Primary outcome timeframe
From date of randomization until the Day 4 post biopsy
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Control Group
group without e-PROs (standard care)
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
65
|
65
|
|
Overall Study
COMPLETED
|
63
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
n=63 Participants
|
55 years
n=65 Participants
|
56 years
n=65 Participants
|
54 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=63 Participants
|
65 Participants
n=65 Participants
|
65 Participants
n=65 Participants
|
193 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=63 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=193 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of biopsy
Macrobiopsy
|
42 Participants
n=63 Participants
|
43 Participants
n=65 Participants
|
42 Participants
n=65 Participants
|
127 Participants
n=193 Participants
|
|
Type of biopsy
Microbiopsy
|
21 Participants
n=63 Participants
|
22 Participants
n=65 Participants
|
23 Participants
n=65 Participants
|
66 Participants
n=193 Participants
|
|
ACR
Grade 3 of ACR (American College of Radiology) better outcome
|
0 participants
n=63 Participants
|
3 participants
n=65 Participants
|
2 participants
n=65 Participants
|
5 participants
n=193 Participants
|
|
ACR
Grade 4-5 of ACR (American College of Radiology worse outcomes
|
63 participants
n=63 Participants
|
62 participants
n=65 Participants
|
63 participants
n=65 Participants
|
188 participants
n=193 Participants
|
|
Pain at the baseline
Pain Score < 4 on a numeric pain scale (from 0 to 10)
|
50 participants
n=63 Participants
|
51 participants
n=65 Participants
|
51 participants
n=65 Participants
|
152 participants
n=193 Participants
|
|
Pain at the baseline
Pain Score >= 4 on a numeric pain scale (from 0 to 10)
|
13 participants
n=63 Participants
|
14 participants
n=65 Participants
|
14 participants
n=65 Participants
|
41 participants
n=193 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the Day 4 post biopsyPain score assessed (by phone) via a numeric pain scale (from 0 "no pain" to 10 "maximal pain")completed 4 days after biopsy (Day 4).
Outcome measures
| Measure |
Experimental Group 1
n=58 Participants
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.
|
Experimental Group 2
n=61 Participants
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.
|
Control Group
n=60 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
Number of Participants by Pain Intensity at Day 4 Post Breast Biopsy With a Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects (Smartphone or Tablet)) Compared of the Standard Follow up
Intense pain Score (6 to 7) on a a numeric pain scale
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants by Pain Intensity at Day 4 Post Breast Biopsy With a Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects (Smartphone or Tablet)) Compared of the Standard Follow up
Moderate pain Score (4 to 5) on a a numeric pain scale
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants by Pain Intensity at Day 4 Post Breast Biopsy With a Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects (Smartphone or Tablet)) Compared of the Standard Follow up
No pain (0) on a a numeric pain scale
|
39 participants
|
43 participants
|
36 participants
|
|
Number of Participants by Pain Intensity at Day 4 Post Breast Biopsy With a Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects (Smartphone or Tablet)) Compared of the Standard Follow up
Low pain score (1 to 3) on a a numeric pain scale
|
19 participants
|
17 participants
|
22 participants
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 10 post biopsyPain 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).
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
Pain Intensity During the Consultation of Results Announcement After a Breast Biopsy Between the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) Compared to the Standard Follow up
Pain score (0,10) at J0 on a numeric pain scale
|
1 score on a scale
Interval 0.0 to 8.0
|
1 score on a scale
Interval 0.0 to 9.0
|
1 score on a scale
Interval 0.0 to 9.0
|
|
Pain Intensity During the Consultation of Results Announcement After a Breast Biopsy Between the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) Compared to the Standard Follow up
Pain score (0,10) at J10 on a numeric pain scale
|
0 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 4 / Day 10 post biopsyPain 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
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
the Benefit According to the Type of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) on the Pain Intensity of Patients at 4 Days (D4) and During the Consultation of Results Announcement After a Breast Biopsy.
Pain score (from 0 to10) at biopsy day on a numeric pain scale
|
2.08 score on a scale
Standard Deviation 2.50
|
1.98 score on a scale
Standard Deviation 2.21
|
1.86 score on a scale
Standard Deviation 1.78
|
|
the Benefit According to the Type of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) on the Pain Intensity of Patients at 4 Days (D4) and During the Consultation of Results Announcement After a Breast Biopsy.
Pain score (from 0 to 10) Day 4 post biopsy on a numeric pain scale
|
0.47 score on a scale
Standard Deviation 0.78
|
0.54 score on a scale
Standard Deviation 1.03
|
0.65 score on a scale
Standard Deviation 1.12
|
|
the Benefit According to the Type of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) on the Pain Intensity of Patients at 4 Days (D4) and During the Consultation of Results Announcement After a Breast Biopsy.
Pain score (from 0 to 10) Day 10 post biopsy on a numeric pain scale
|
0.75 score on a scale
Standard Deviation 1.35
|
0.54 score on a scale
Standard Deviation 1.10
|
0.54 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 4 and Day 10 post biopsyAnxiety 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)
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Anxiety Intensity of Patients at 4 Days and During the Consultation of Results Announcement, After a Breast Biopsy.
Anxiety score (0,10) at J0 on a numeric anxiety scale
|
4.52 score on a scale
Standard Deviation 3.02
|
4.12 score on a scale
Standard Deviation 3.31
|
4.57 score on a scale
Standard Deviation 3.27
|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Anxiety Intensity of Patients at 4 Days and During the Consultation of Results Announcement, After a Breast Biopsy.
Anxiety score (0,10) at J4 a numeric anxiety scale
|
1.88 score on a scale
Standard Deviation 1.63
|
2.51 score on a scale
Standard Deviation 2.75
|
3.80 score on a scale
Standard Deviation 2.50
|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Anxiety Intensity of Patients at 4 Days and During the Consultation of Results Announcement, After a Breast Biopsy.
Anxiety score (0,10) at J10 a numeric anxiety scale
|
3.43 score on a scale
Standard Deviation 3.02
|
3.83 score on a scale
Standard Deviation 3.00
|
4.65 score on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 4 and Day 10 post biopsyEsthetic 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
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Esthetic Impact of Patients at 4 and 10 Days (D4, D10) After a Breast Biopsy.
Esthetic Impact (0-100) at J0 on a numeric scale
|
4.29 score on a scale
Standard Deviation 10.88
|
4.06 score on a scale
Standard Deviation 8.49
|
6.41 score on a scale
Standard Deviation 12.77
|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Esthetic Impact of Patients at 4 and 10 Days (D4, D10) After a Breast Biopsy.
Esthetic Impact (0-100) at J4 on a numeric scale
|
7.69 score on a scale
Standard Deviation 19.00
|
10.05 score on a scale
Standard Deviation 21.77
|
4.18 score on a scale
Standard Deviation 8.43
|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of the Esthetic Impact of Patients at 4 and 10 Days (D4, D10) After a Breast Biopsy.
Esthetic Impact (0-100) at J10 on a numeric scale
|
8.69 score on a scale
Standard Deviation 17.08
|
8.54 score on a scale
Standard Deviation 15.91
|
3.08 score on a scale
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 10 post biopsyInsomnia score assessed using the Index of Severity of Insomnia (from 0 "no insomnia" to 28 "maximal insomnia") administered at 10 days post biopsy
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
the Benefit According to the Type of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) on the Insomnia of Patients at 10 Days (About Day 10), After a Breast Biopsy.
Insomnia score (0 to 28) at J0
|
7.88 score on a scale
Standard Deviation 5.90
|
7.42 score on a scale
Standard Deviation 5.97
|
7.22 score on a scale
Standard Deviation 5.57
|
|
the Benefit According to the Type of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) on the Insomnia of Patients at 10 Days (About Day 10), After a Breast Biopsy.
Insomnia score (0 to 28) at J10
|
7.43 score on a scale
Standard Deviation 6.43
|
6.65 score on a scale
Standard Deviation 5.95
|
7.34 score on a scale
Standard Deviation 5.91
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 4 and the Day 10 post biopsyNumber of alerts that generated a phone call or number of phone calls generated directly by the patient and patient care accordingly.
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management
Phone call
|
60 participants
|
62 participants
|
62 participants
|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management
No phone call
|
0 participants
|
1 participants
|
0 participants
|
|
the Benefit of Intervention by E-health (Phone Consultation With a Professional or Connected Objects) With the Standard Follow up of Patient's Management
No data
|
3 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 4 and Day 10 post biopsyQuantity, nature and dose of treatments used for the biopsy and its aftermath.
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
the Use of a Biopsy-related Drug Intervention in Patients With E-health Interventions (Phone Consultation or Smartphone), With the Standard Follow-up, at 10 Days After a Breast Biopsy.
concomitant treatment
|
23 participants
|
28 participants
|
27 participants
|
|
the Use of a Biopsy-related Drug Intervention in Patients With E-health Interventions (Phone Consultation or Smartphone), With the Standard Follow-up, at 10 Days After a Breast Biopsy.
No concomitant treatment
|
40 participants
|
36 participants
|
38 participants
|
|
the Use of a Biopsy-related Drug Intervention in Patients With E-health Interventions (Phone Consultation or Smartphone), With the Standard Follow-up, at 10 Days After a Breast Biopsy.
No data
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From date of randomization until the Day 4 and the Day 10 post biopsyAdverse 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
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
Adverse Events in Patients With E-health Interventions (Phone Consultation With a Professional or Connected Objects), With the Standard Follow-up, During the Consultation of Results Announcement (About D10) After a Breast Biopsy.
Bleeding
|
0 participants
|
1 participants
|
1 participants
|
|
Adverse Events in Patients With E-health Interventions (Phone Consultation With a Professional or Connected Objects), With the Standard Follow-up, During the Consultation of Results Announcement (About D10) After a Breast Biopsy.
no bleeding
|
63 participants
|
64 participants
|
64 participants
|
|
Adverse Events in Patients With E-health Interventions (Phone Consultation With a Professional or Connected Objects), With the Standard Follow-up, During the Consultation of Results Announcement (About D10) After a Breast Biopsy.
Infection
|
0 participants
|
0 participants
|
0 participants
|
|
Adverse Events in Patients With E-health Interventions (Phone Consultation With a Professional or Connected Objects), With the Standard Follow-up, During the Consultation of Results Announcement (About D10) After a Breast Biopsy.
no infection
|
63 participants
|
65 participants
|
65 participants
|
SECONDARY outcome
Timeframe: at the Day 10 post biopsyNumber 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.
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
Assess Satisfaction With Specific Study Management.
7 on a numeric scale (from 0 to 10)
|
2 participants
|
1 participants
|
1 participants
|
|
Assess Satisfaction With Specific Study Management.
8 on a numeric scale (from 0 to 10)
|
2 participants
|
6 participants
|
6 participants
|
|
Assess Satisfaction With Specific Study Management.
9 on a numeric scale (from 0 to 10)
|
25 participants
|
15 participants
|
20 participants
|
|
Assess Satisfaction With Specific Study Management.
10 on a numeric scale (from 0 to 10)
|
28 participants
|
41 participants
|
38 participants
|
|
Assess Satisfaction With Specific Study Management.
no Data
|
6 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at the Day 1, 2 and 3Population: 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
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
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
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.
|
Control Group
group without e-PROs (standard care)
|
|---|---|---|---|
|
Assess Compliance.
completion questionnaire at Day 1
|
60 participants
|
—
|
—
|
|
Assess Compliance.
completion questionnaire at Day 2
|
60 participants
|
—
|
—
|
|
Assess Compliance.
completion questionnaire at DAy 3
|
59 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the Day 3numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfaction). no response 1, 2, 3, 4, 5 and 6
Outcome measures
| Measure |
Experimental Group 1
n=63 Participants
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.
|
Experimental Group 2
n=65 Participants
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.
|
Control Group
n=65 Participants
group without e-PROs (standard care)
|
|---|---|---|---|
|
Assess Compliance.
satisfy Score 7 on a numeric scale
|
2 participants
|
1 participants
|
1 participants
|
|
Assess Compliance.
satisfy Score 8 on a numeric scale
|
2 participants
|
6 participants
|
6 participants
|
|
Assess Compliance.
satisfy Score 9 on a numeric scale
|
25 participants
|
15 participants
|
20 participants
|
|
Assess Compliance.
satisfy Score 10 on a numeric scale
|
28 participants
|
41 participants
|
38 participants
|
|
Assess Compliance.
No data
|
6 participants
|
2 participants
|
0 participants
|
Adverse Events
Experimental Group 1
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Experimental Group 2
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group 1
n=63 participants at risk
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.
|
Experimental Group 2
n=65 participants at risk
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.
|
Control Group
n=65 participants at risk
group without e-PROs (standard care)
|
|---|---|---|---|
|
General disorders
PAIN
|
15.9%
10/63 • Number of events 14 • From randomization ti Day 10 post Biopsy
|
1.5%
1/65 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
4.6%
3/65 • Number of events 4 • From randomization ti Day 10 post Biopsy
|
|
General disorders
Anxiety
|
36.5%
23/63 • Number of events 49 • From randomization ti Day 10 post Biopsy
|
20.0%
13/65 • Number of events 15 • From randomization ti Day 10 post Biopsy
|
36.9%
24/65 • Number of events 30 • From randomization ti Day 10 post Biopsy
|
|
Musculoskeletal and connective tissue disorders
Esthetic Impact
|
3.2%
2/63 • Number of events 3 • From randomization ti Day 10 post Biopsy
|
4.6%
3/65 • Number of events 4 • From randomization ti Day 10 post Biopsy
|
1.5%
1/65 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
|
Blood and lymphatic system disorders
Edema
|
3.2%
2/63 • Number of events 3 • From randomization ti Day 10 post Biopsy
|
3.1%
2/65 • Number of events 2 • From randomization ti Day 10 post Biopsy
|
0.00%
0/65 • From randomization ti Day 10 post Biopsy
|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/63 • From randomization ti Day 10 post Biopsy
|
1.5%
1/65 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
1.5%
1/65 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
|
Blood and lymphatic system disorders
Arthrophlebitis
|
1.6%
1/63 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
0.00%
0/65 • From randomization ti Day 10 post Biopsy
|
0.00%
0/65 • From randomization ti Day 10 post Biopsy
|
|
Blood and lymphatic system disorders
Hematome
|
6.3%
4/63 • Number of events 12 • From randomization ti Day 10 post Biopsy
|
9.2%
6/65 • Number of events 7 • From randomization ti Day 10 post Biopsy
|
1.5%
1/65 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
|
General disorders
Irritation
|
0.00%
0/63 • From randomization ti Day 10 post Biopsy
|
1.5%
1/65 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
0.00%
0/65 • From randomization ti Day 10 post Biopsy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/63 • Number of events 2 • From randomization ti Day 10 post Biopsy
|
0.00%
0/65 • From randomization ti Day 10 post Biopsy
|
0.00%
0/65 • From randomization ti Day 10 post Biopsy
|
|
General disorders
Insomnia
|
1.6%
1/63 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
0.00%
0/65 • From randomization ti Day 10 post Biopsy
|
1.5%
1/65 • Number of events 1 • From randomization ti Day 10 post Biopsy
|
Additional Information
Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation
INSTITUT REGIONAL DU CANCER DE MONTPELLIER
Phone: 0467613102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place