<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456920</url>
  </required_header>
  <id_info>
    <org_study_id>PROICM 2020-06 BIO</org_study_id>
    <nct_id>NCT04456920</nct_id>
  </id_info>
  <brief_title>Pain Monitoring After Breast Biopsy: Benefit of E-health</brief_title>
  <acronym>BIO-PSY</acronym>
  <official_title>Pain Monitoring After Breast Biopsy: Benefit of E-health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Each year, approximately 1500 breast biopsies (1000 microbiopsies and 500 macrobiopsies) are&#xD;
      performed in the radiologic department of the Montpellier Cancer Institute (ICM). This exam,&#xD;
      which is relatively easy for the radiologist, can however lead to major anxiety for patients.&#xD;
      Indeed, previous studies show that about 50% of women undergoing a breast biopsy have&#xD;
      significant anxiety affects.&#xD;
&#xD;
      Anxiety associated with the risks of biopsy, potential breast cancer diagnosis and/or lack of&#xD;
      routine sedation procedures increase patient concerns. Distress prior to biopsy is associated&#xD;
      with greater pain and discomfort during the procedure. The psychological distress that&#xD;
      persists after the biopsy is related to a worse psychological management of side effects of&#xD;
      the biopsy breast (e.g., sensitivity, skin irritation).&#xD;
&#xD;
      Limiting apprehension, worry and anxiety induced by the uncertainty linked to the biopsy&#xD;
      results and the biopsy-related pain should be an integral part of the medical care through&#xD;
      the patient follow-up during, after and until the diagnosis is announced. In light of these&#xD;
      challenges, new alternative methods are emerging to enhance patient knowledge, develop&#xD;
      procedural skills, improve confidence and mitigate procedural anxiety. However, to our&#xD;
      knowledge, few methods have been developed during this period of 'waiting-time'. Currently,&#xD;
      only care instructions and a consultation to announce the results (about 10 days after the&#xD;
      procedure) are proposed to patients at the end of biopsy. Patients are also encouraged to&#xD;
      call if they suspect complications such as infection or bleeding.&#xD;
&#xD;
      In this context, the investigators propose to integrate a pain management after biopsy via&#xD;
      e-health system through the patient's medical care. Radiologist/patient communication could&#xD;
      have an impact on patients' anxiety and health-related issues, given the challenging nature&#xD;
      of discussions around need for breast biopsy and potential implications of the results.&#xD;
      Indeed, paying attention and focusing on symptoms as patients experience them improves their&#xD;
      empowerment and their adjustment to the disease.&#xD;
&#xD;
      Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been&#xD;
      shown to prompt clinicians to intensify symptom management, to improve symptom control and to&#xD;
      enhance patient-clinician communication patient satisfaction, as well as well-being. In&#xD;
      addition, it is known that improved communication between patients and medical staff to less&#xD;
      anxiety after a biopsy and that anxiety is related to pain.&#xD;
&#xD;
      Taken as a whole, these elements encourage the integration of e-health and e-PRO for the&#xD;
      management of pain and anxiety in patients undergoing a biopsy. The benefits of e-PRO are&#xD;
      still being discussed in terms of quality of life (Qol) and psychological distress. The&#xD;
      investigator propose to integrate two types of e-health intervention: 1/e-PRO collected by&#xD;
      connected objects (smartphone or tablet) as they were used in previous studies, and 2/ e-PRO&#xD;
      collected by a phone consultation, which values human communication between the medical staff&#xD;
      and the patient.&#xD;
&#xD;
      In case of significant pain, the collection of e-PRO by any of these e-health interventions&#xD;
      will generate an alert and a reactive and responsive care.&#xD;
&#xD;
      In fine, the purpose of this research is to improve the medical organization and care of&#xD;
      post-biopsy patients by proposing an innovative connected patient technology, regardless of&#xD;
      their remoteness from the hospital.&#xD;
&#xD;
      Social inequalities will be reduced by lending a tablet to patients who do not have such a&#xD;
      device with a 4G key.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to compare the benefit of intervention by e-health (phone&#xD;
      consultation with a professional or connected objects (smartphone or tablet)) with the&#xD;
      standard follow up of the pain intensity of patients 4 days (D4) after un breast biopsy.&#xD;
&#xD;
      This study is a Monocentric, prospective, open-labeled, randomized controlled trial. A total&#xD;
      of 192 patients (64 patients in group control vs 64 patients in experimental group 1 (PRO&#xD;
      gathered via a phone consultation) and 64 patients in experimental group 2 (e-PRO&#xD;
      self-completed via connected objects (tablet/phone) will be required including 10% of&#xD;
      lost-to-follow-up patients.&#xD;
&#xD;
      The inclusion period would be 8 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 9, 2021</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>From date of randomization until the Day 4 post biopsy</time_frame>
    <description>Pain score assessed (by phone) via a numeric pain scale (from 0 &quot;no pain&quot; to 10 &quot;maximal pain&quot;)completed 4 days after biopsy (Day 4).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the pain intensity of patients during the consultation of results announcement (about Day 10) after a breast biopsy.</measure>
    <time_frame>From date of randomization until the Day 10 post biopsy</time_frame>
    <description>Pain score assessed using a numeric pain scale (from 0 &quot;no pain&quot; to 10 &quot;maximal pain&quot;) administered after to biopsy and during the consultation of results announcement (approximately Day 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <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 and 10 days (Day 4, Day 10) after a breast biopsy.</measure>
    <time_frame>From date of randomization until the Day 4 / Day 10 post biopsy</time_frame>
    <description>Pain score assessed using a numeric pain scale (from 0 &quot;no pain&quot; to 10 &quot;maximal pain&quot;) administered after to biopsy, at 4 days and 10 days post biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <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 and 10 days (Day 4, Day 10) after a breast biopsy.</measure>
    <time_frame>From date of randomization until the Day 4 and Day 10 post biopsy</time_frame>
    <description>Anxiety score assessed using a numeric anxiety scale (from 0 &quot;no anxiety&quot; to 10 &quot;maximal anxiety&quot;) administered after to biopsy, at 4 days (Day 4) and 10 days (Day 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the benefit according to the type of intervention by e-health (phone consultation with a professional or connected objects) on the anxiety intensity of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy.</measure>
    <time_frame>From date of randomization until the Day 4 and Day 10 post biopsy</time_frame>
    <description>Anxiety score assessed using a numeric anxiety scale (from 0 &quot;no anxiety&quot; to 10 &quot;maximal anxiety&quot;) administered after to biopsy, at 4 days and 10 days post biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>From date of randomization until the Day 4 and Day 10 post biopsy</time_frame>
    <description>Esthetic impact score assessed using a numeric esthetic scale (from 0 &quot;no impact&quot; to 100 &quot;maximal impact&quot;) administered after to biopsy, at 4 days and 10 days post biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the benefit according to the type of intervention by e-health (phone consultation with a professional or connected objects) on the esthetic impact of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy.</measure>
    <time_frame>From date of randomization until the Day 4 and Day 10 post biopsy</time_frame>
    <description>Esthetic impact score assessed using a numeric esthetic scale (from 0 &quot;no impact&quot; to 100 &quot;maximal impact&quot;) administered after to biopsy, at 4 days and 10 days post biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the insomnia of patients at 4 and 10 days after a breast biopsy.</measure>
    <time_frame>From date of randomization until the Day 10 post biopsy</time_frame>
    <description>Insomnia score assessed using the Index of Severity of Insomnia administered (from 0 &quot;no insomnia&quot; to 28 &quot;maximal insomnia&quot;) during the baseline visit and the consultation of results announcement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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 4 days (Day 4) and at 10 days (about Day 10), after a breast biopsy.</measure>
    <time_frame>From date of randomization until the Day 10 post biopsy</time_frame>
    <description>Insomnia score assessed using the Index of Severity of Insomnia (from 0 &quot;no insomnia&quot; to 28 &quot;maximal insomnia&quot;) administered at 10 days post biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>From date of randomization until the Day 4 and the Day 10 post biopsy</time_frame>
    <description>Number of alerts that generated a phone call or number of phone calls generated directly by the patient and patient care accordingly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>From date of randomization until the Day 4 and Day 10 post biopsy</time_frame>
    <description>Quantity, nature and dose of treatments used for the biopsy and its aftermath.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>From date of randomization until the Day 4 and the Day 10 post biopsy</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assess satisfaction with specific study management.</measure>
    <time_frame>From date of randomization until the Day 4 and the Day 10 post biopsy</time_frame>
    <description>Number of positive responses to satisfaction questions related to the number of solicitations for the study and how interventions are communicated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assess compliance.</measure>
    <time_frame>From date of randomization until the Day 3</time_frame>
    <description>Rate of completion questionnaire (on the application)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assess compliance.</measure>
    <time_frame>From date of randomization until the Day 3</time_frame>
    <description>numeric scale (likert scala : (from 0 &quot;no satisfy&quot; to 10 &quot;maximal satisfy&quot;)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">192</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Biopsy Wound</condition>
  <arm_group>
    <arm_group_label>Experimental group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRO (Patient Reported Outcomes) gathered via a phone consultation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>e-PRO self-completed via connected objects (tablet/phone)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>group without e-PROs (standard care)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phone consultation</intervention_name>
    <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.</description>
    <arm_group_label>Experimental group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>e-PRO self-completed via connected objects (tablet/phone)</intervention_name>
    <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</description>
    <arm_group_label>Experimental group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phone consultation</intervention_name>
    <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.</description>
    <arm_group_label>Experimental group 1</arm_group_label>
    <arm_group_label>Experimental group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>visit</intervention_name>
    <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.</description>
    <arm_group_label>Experimental group 1</arm_group_label>
    <arm_group_label>Experimental group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with diagnostic breast biopsy at ICM&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Informed patient and signed informed consent received&#xD;
&#xD;
          -  Affiliation to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient without phone number&#xD;
&#xD;
          -  Patient with previous biopsy in 6 months prior to study&#xD;
&#xD;
          -  Pregnant and breastfeeding woman&#xD;
&#xD;
          -  Patient whose regular follow-up is initially impossible for psychological, family,&#xD;
             social or geographical reasons&#xD;
&#xD;
          -  Patient under legal protection (guardianship, curatorship or safeguarding of justice)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nougaret Stéphanie, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Institut du Cancer de Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Moussion Aurore</last_name>
    <phone>0467612446</phone>
    <email>aurore.moussion@icm.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Texier Emmanuelle</last_name>
    <phone>0467613102</phone>
    <email>DRCI-icm105@cm.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Icm Val D'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <state>Hérault</state>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nougaret Stéphanie, MD</last_name>
      <phone>0467618521</phone>
      <email>stephanie.nougaret@icm.unicancer.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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    <citation>Atkinson TM, Ryan SJ, Bennett AV, Stover AM, Saracino RM, Rogak LJ, Jewell ST, Matsoukas K, Li Y, Basch E. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 2016 Jun 3.</citation>
    <PMID>27260018</PMID>
  </reference>
  <reference>
    <citation>Miller LS, Shelby RA, Balmadrid MH, Yoon S, Baker JA, Wildermann L, Soo MS. Patient anxiety before and immediately after imaging-guided breast biopsy procedures: impact of radiologist-patient communication. J Am Coll Radiol. 2013 Jun;10(6):423-31. doi: 10.1016/j.jacr.2012.11.005. Epub 2013 Mar 15.</citation>
    <PMID>23499400</PMID>
  </reference>
  <reference>
    <citation>Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. No abstract available.</citation>
    <PMID>4899510</PMID>
  </reference>
  <reference>
    <citation>Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.</citation>
    <PMID>21621130</PMID>
  </reference>
  <reference>
    <citation>Wilkie D, Lovejoy N, Dodd M, Tesler M. Cancer pain intensity measurement: concurrent validity of three tools--finger dynamometer, pain intensity number scale, visual analogue scale. Hosp J. 1990;6(1):1-13. doi: 10.1080/0742-969x.1990.11882662.</citation>
    <PMID>2379920</PMID>
  </reference>
  <reference>
    <citation>Chen PY, Yang CM, Morin CM. Validating the cross-cultural factor structure and invariance property of the Insomnia Severity Index: evidence based on ordinal EFA and CFA. Sleep Med. 2015 May;16(5):598-603. doi: 10.1016/j.sleep.2014.11.016. Epub 2015 Feb 12.</citation>
    <PMID>25863811</PMID>
  </reference>
  <reference>
    <citation>Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44. doi: 10.1177/1054773803262222.</citation>
    <PMID>15245638</PMID>
  </reference>
  <reference>
    <citation>Hodkinson B, Maheu E, Michon M, Carrat F, Berenbaum F. Assessment and determinants of aesthetic discomfort in hand osteoarthritis. Ann Rheum Dis. 2012 Jan;71(1):45-9. doi: 10.1136/ard.2011.153965. Epub 2011 Sep 6.</citation>
    <PMID>21900283</PMID>
  </reference>
  <reference>
    <citation>Yennurajalingam S, Kang JH, Hui D, Kang DH, Kim SH, Bruera E. Clinical response to an outpatient palliative care consultation in patients with advanced cancer and cancer pain. J Pain Symptom Manage. 2012 Sep;44(3):340-50. doi: 10.1016/j.jpainsymman.2011.09.014. Epub 2012 Jun 13.</citation>
    <PMID>22699092</PMID>
  </reference>
  <reference>
    <citation>den Heijer M, Seynaeve C, Vanheusden K, Duivenvoorden HJ, Bartels CC, Menke-Pluymers MB, Tibben A. Psychological distress in women at risk for hereditary breast cancer: the role of family communication and perceived social support. Psychooncology. 2011 Dec;20(12):1317-23. doi: 10.1002/pon.1850. Epub 2010 Oct 5.</citation>
    <PMID>20925135</PMID>
  </reference>
  <reference>
    <citation>Manne S, Myers S, Ozga M, Kissane D, Kashy D, Rubin S, Heckman C, Rosenblum N. Holding back sharing concerns, dispositional emotional expressivity, perceived unsupportive responses and distress among women newly diagnosed with gynecological cancers. Gen Hosp Psychiatry. 2014 Jan-Feb;36(1):81-7. doi: 10.1016/j.genhosppsych.2013.10.001. Epub 2013 Oct 9.</citation>
    <PMID>24211156</PMID>
  </reference>
  <reference>
    <citation>Cordova MJ, Cunningham LL, Carlson CR, Andrykowski MA. Social constraints, cognitive processing, and adjustment to breast cancer. J Consult Clin Psychol. 2001 Aug;69(4):706-11.</citation>
    <PMID>11550737</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456920
org study id: PROICM 2020-06 BIO
nct id: NCT04456920
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Each year, approximately 1500 breast biopsies (1000 microbiopsies and 500 macrobiopsies) are
      performed in the radiologic department of the Montpellier Cancer Institute (ICM). This exam,
      which is relatively easy for the radiologist, can however lead to major anxiety for patients.
      Indeed, previous studies show that about 50% of women undergoing a breast biopsy have
      significant anxiety affects.

      Anxiety associated with the risks of biopsy, potential breast cancer diagnosis and/or lack of
      routine sedation procedures increase patient concerns. Distress prior to biopsy is associated
      with greater pain and discomfort during the procedure. The psychological distress that
      persists after the biopsy is related to a worse psychological management of side effects of
      the biopsy breast (e.g., sensitivity, skin irritation).

      Limiting apprehension, worry and anxiety induced by the uncertainty linked to the biopsy
      results and the biopsy-related pain should be an integral part of the medical care through
      the patient follow-up during, after and until the diagnosis is announced. In light of these
      challenges, new alternative methods are emerging to enhance patient knowledge, develop
      procedural skills, improve confidence and mitigate procedural anxiety. However, to our
      knowledge, few methods have been developed during this period of 'waiting-time'. Currently,
      only care instructions and a consultation to announce the results (about 10 days after the
      procedure) are proposed to patients at the end of biopsy. Patients are also encouraged to
      call if they suspect complications such as infection or bleeding.

      In this context, the investigators propose to integrate a pain management after biopsy via
      e-health system through the patient's medical care. Radiologist/patient communication could
      have an impact on patients' anxiety and health-related issues, given the challenging nature
      of discussions around need for breast biopsy and potential implications of the results.
      Indeed, paying attention and focusing on symptoms as patients experience them improves their
      empowerment and their adjustment to the disease.

      Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been
      shown to prompt clinicians to intensify symptom management, to improve symptom control and to
      enhance patient-clinician communication patient satisfaction, as well as well-being. In
      addition, it is known that improved communication between patients and medical staff to less
      anxiety after a biopsy and that anxiety is related to pain.

      Taken as a whole, these elements encourage the integration of e-health and e-PRO for the
      management of pain and anxiety in patients undergoing a biopsy. The benefits of e-PRO are
      still being discussed in terms of quality of life (Qol) and psychological distress. The
      investigator propose to integrate two types of e-health intervention: 1/e-PRO collected by
      connected objects (smartphone or tablet) as they were used in previous studies, and 2/ e-PRO
      collected by a phone consultation, which values human communication between the medical staff
      and the patient.

      In case of significant pain, the collection of e-PRO by any of these e-health interventions
      will generate an alert and a reactive and responsive care.

      In fine, the purpose of this research is to improve the medical organization and care of
      post-biopsy patients by proposing an innovative connected patient technology, regardless of
      their remoteness from the hospital.

      Social inequalities will be reduced by lending a tablet to patients who do not have such a
      device with a 4G key.
The primary objective is to compare the benefit of intervention by e-health (phone
      consultation with a professional or connected objects (smartphone or tablet)) with the
      standard follow up of the pain intensity of patients 4 days (D4) after un breast biopsy.

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

      The inclusion period would be 8 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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
time frame: 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).
measure: the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the pain intensity of patients during the consultation of results announcement (about Day 10) after a breast biopsy.
time frame: 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 and 10 days (Day 4, Day 10) after a breast biopsy.
time frame: 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 and 10 days (Day 4, Day 10) after a breast biopsy.
time frame: 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 according to the type of intervention by e-health (phone consultation with a professional or connected objects) on the anxiety intensity of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy.
time frame: 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 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 esthetic impact of patients at 4 and 10 days (D4, D10) after a breast biopsy.
time frame: 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 esthetic impact of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy.
time frame: 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 of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the insomnia of patients at 4 and 10 days after a breast biopsy.
time frame: From date of randomization until the Day 10 post biopsy
description: Insomnia score assessed using the Index of Severity of Insomnia administered (from 0 "no insomnia" to 28 "maximal insomnia") during the baseline visit and the consultation of results announcement.
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 4 days (Day 4) and at 10 days (about Day 10), after a breast biopsy.
time frame: 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
time frame: 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.
time frame: 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.
time frame: 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.
time frame: From date of randomization until the Day 4 and the Day 10 post biopsy
description: Number of positive responses to satisfaction questions related to the number of solicitations for the study and how interventions are communicated
measure: assess compliance.
time frame: From date of randomization until the Day 3
description: Rate of completion questionnaire (on the application)
measure: assess compliance.
time frame: From date of randomization until the Day 3
description: numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfy")
arm group label: Experimental group 1
arm group type: Experimental
description: PRO (Patient Reported Outcomes) gathered via a phone consultation
arm group label: Experimental group 2
arm group type: Experimental
description: e-PRO self-completed via connected objects (tablet/phone)
arm group label: Control group
arm group type: No Intervention
description: group without e-PROs (standard care)
intervention type: Other
intervention name: phone consultation
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.
arm group label: Experimental group 1
intervention type: Other
intervention name: e-PRO self-completed via connected objects (tablet/phone)
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
arm group label: Experimental group 2
intervention type: Other
intervention name: phone consultation
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.
arm group label: Experimental group 1
arm group label: Experimental group 2
intervention type: Other
intervention name: visit
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.
arm group label: Experimental group 1
arm group label: Experimental group 2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nougaret Stéphanie, MD
role: Study Chair
affiliation: Institut du Cancer de Montpellier
last name: Moussion Aurore
phone: 0467612446
email: aurore.moussion@icm.unicancer.fr
last name: Texier Emmanuelle
phone: 0467613102
email: DRCI-icm105@cm.unicancer.fr
facility: 
status: Recruiting
contact: 
country: France
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citation: Atkinson TM, Ryan SJ, Bennett AV, Stover AM, Saracino RM, Rogak LJ, Jewell ST, Matsoukas K, Li Y, Basch E. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 2016 Jun 3.
PMID: 27260018
citation: Miller LS, Shelby RA, Balmadrid MH, Yoon S, Baker JA, Wildermann L, Soo MS. Patient anxiety before and immediately after imaging-guided breast biopsy procedures: impact of radiologist-patient communication. J Am Coll Radiol. 2013 Jun;10(6):423-31. doi: 10.1016/j.jacr.2012.11.005. Epub 2013 Mar 15.
PMID: 23499400
citation: Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. No abstract available.
PMID: 4899510
citation: Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
PMID: 21621130
citation: Wilkie D, Lovejoy N, Dodd M, Tesler M. Cancer pain intensity measurement: concurrent validity of three tools--finger dynamometer, pain intensity number scale, visual analogue scale. Hosp J. 1990;6(1):1-13. doi: 10.1080/0742-969x.1990.11882662.
PMID: 2379920
citation: Chen PY, Yang CM, Morin CM. Validating the cross-cultural factor structure and invariance property of the Insomnia Severity Index: evidence based on ordinal EFA and CFA. Sleep Med. 2015 May;16(5):598-603. doi: 10.1016/j.sleep.2014.11.016. Epub 2015 Feb 12.
PMID: 25863811
citation: Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44. doi: 10.1177/1054773803262222.
PMID: 15245638
citation: Hodkinson B, Maheu E, Michon M, Carrat F, Berenbaum F. Assessment and determinants of aesthetic discomfort in hand osteoarthritis. Ann Rheum Dis. 2012 Jan;71(1):45-9. doi: 10.1136/ard.2011.153965. Epub 2011 Sep 6.
PMID: 21900283
citation: Yennurajalingam S, Kang JH, Hui D, Kang DH, Kim SH, Bruera E. Clinical response to an outpatient palliative care consultation in patients with advanced cancer and cancer pain. J Pain Symptom Manage. 2012 Sep;44(3):340-50. doi: 10.1016/j.jpainsymman.2011.09.014. Epub 2012 Jun 13.
PMID: 22699092
citation: den Heijer M, Seynaeve C, Vanheusden K, Duivenvoorden HJ, Bartels CC, Menke-Pluymers MB, Tibben A. Psychological distress in women at risk for hereditary breast cancer: the role of family communication and perceived social support. Psychooncology. 2011 Dec;20(12):1317-23. doi: 10.1002/pon.1850. Epub 2010 Oct 5.
PMID: 20925135
citation: Manne S, Myers S, Ozga M, Kissane D, Kashy D, Rubin S, Heckman C, Rosenblum N. Holding back sharing concerns, dispositional emotional expressivity, perceived unsupportive responses and distress among women newly diagnosed with gynecological cancers. Gen Hosp Psychiatry. 2014 Jan-Feb;36(1):81-7. doi: 10.1016/j.genhosppsych.2013.10.001. Epub 2013 Oct 9.
PMID: 24211156
citation: Cordova MJ, Cunningham LL, Carlson CR, Andrykowski MA. Social constraints, cognitive processing, and adjustment to breast cancer. J Consult Clin Psychol. 2001 Aug;69(4):706-11.
PMID: 11550737
responsible party type: Sponsor
sharing ipd: No