<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/NCT03777852</url>
  </required_header>
  <id_info>
    <org_study_id>Juçara Phd Thesis</org_study_id>
    <secondary_id>Helio Carrara</secondary_id>
    <nct_id>NCT03777852</nct_id>
  </id_info>
  <brief_title>Emotional Evaluation and Reconstructed Breast Satisfaction</brief_title>
  <official_title>Emotional Evaluation and Reconstructed Breast Satisfaction After Breast Cancer Treatment: Breast Q Questionary</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      Data from the National Cancer Institute (Inca) reveal that breast cancer is the most common&#xD;
      type of cancer among women worldwide. In Brazil, it is second only to non-melanoma skin&#xD;
      cancer. Breast cancer is a feared disease in the female universe because it is considered one&#xD;
      of the major causes of death due to neoplasia among women. It brings also the stigma of&#xD;
      suffering, mutilation, loss of female identity and loss of body contour. Among other issues,&#xD;
      problems with body self-image may have an impact on sexuality and fertility, and also, the&#xD;
      incapacity to breastfeed. Breast reconstruction can restore the patient's shape and physical&#xD;
      integrity, among other benefits. The research justifies itself because information about the&#xD;
      satisfaction of breast reconstruction can be achieved. It is also known that women having&#xD;
      breast reconstruction after a mastectomy due to cancer have a favorable evolution. This study&#xD;
      will analyze body contour satisfaction of women undergoing mastectomy and breast&#xD;
      reconstruction as part of their breast cancer treatment. The Breast Q questionnaire will be&#xD;
      used to measure patients satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, quasi-experimental study. The subject sample will be composed of women&#xD;
      submitted to mastectomy due to breast cancer and to breast reconstruction as part of their&#xD;
      treatment. They will be evaluated twice. One when they receive the cancer diagnosis and the&#xD;
      other six months after de reconstruction surgery. On both occasions, they will answer the&#xD;
      Brest Q questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A group of women will be evaluated twice, being one before the intervention and the second after the breast cancer reconstruction surgery</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-treatment Satisfaction</measure>
    <time_frame>Six month</time_frame>
    <description>Comparison of results between the first and the second Breast Q score. This score represents questionnaries about diferents domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Malignant Neoplasm of the Breast</condition>
  <arm_group>
    <arm_group_label>Pre-surgery First Breast Q</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-surgery Second Breast Q</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Second Breast Q questionnaire will be applied to this group that will be composed of the women of the first group submitted to reconstructive breast cancer surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>First Questionnaire application</intervention_name>
    <description>Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.</description>
    <arm_group_label>Pre-surgery First Breast Q</arm_group_label>
    <other_name>First Breast Q questionnaire</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Second Questionnaire application</intervention_name>
    <description>Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.</description>
    <arm_group_label>Post-surgery Second Breast Q</arm_group_label>
    <other_name>Post reconstruction breast cancer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women over eighteen years of age;&#xD;
&#xD;
          -  women with proven histological diagnosis of breast cancer;&#xD;
&#xD;
          -  women who have an indication of mastectomy as part of their treatment;&#xD;
&#xD;
          -  women who have breast reconstruction, regardless of the technique used, as part of&#xD;
             their treatment;&#xD;
&#xD;
          -  women under 70 years of age at the time of the reconstructive surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women diagnosed with breast cancer and treated with conservative surgeries;&#xD;
&#xD;
          -  women who refuse reconstruction as part of treatment;&#xD;
&#xD;
          -  women who refused surgery as part of the treatment for breast cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helio HA Carrara, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynecology &amp; Obstetrics Departament, Ribeirão Preto Medical School, USP.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Helio HA Carrara, MD, PhD</last_name>
    <phone>551636021000</phone>
    <phone_ext>2589</phone_ext>
    <email>carrara@fmrp.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francisco JC Reis, MD, PhD</last_name>
    <phone>551636022589</phone>
    <email>fjcreis@fmrp.usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clínicas de Ribeirão Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>SP</state>
        <zip>14048900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Cohen WA, Mundy LR, Ballard TN, Klassen A, Cano SJ, Browne J, Pusic AL. The BREAST-Q in surgical research: A review of the literature 2009-2015. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):149-62. doi: 10.1016/j.bjps.2015.11.013. Epub 2015 Nov 26.</citation>
    <PMID>26740288</PMID>
  </reference>
  <reference>
    <citation>Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.</citation>
    <PMID>19644246</PMID>
  </reference>
  <reference>
    <citation>Mundy LR, Homa K, Klassen AF, Pusic AL, Kerrigan CL. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2017 May;139(5):1046e-1055e. doi: 10.1097/PRS.0000000000003241.</citation>
    <PMID>28445351</PMID>
  </reference>
  <reference>
    <citation>Payne RM, Siotos C, Manahan MA, Rosson GD, Cooney CM. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2018 Jan;141(1):180e-181e. doi: 10.1097/PRS.0000000000003970. No abstract available.</citation>
    <PMID>28938344</PMID>
  </reference>
  <reference>
    <citation>Saiga M, Taira N, Kimata Y, Watanabe S, Mukai Y, Shimozuma K, Mizoo T, Nogami T, Iwamoto T, Motoki T, Shien T, Matsuoka J, Doihara H. Development of a Japanese version of the BREAST-Q and the traditional psychometric test of the mastectomy module for the assessment of HRQOL and patient satisfaction following breast surgery. Breast Cancer. 2017 Mar;24(2):288-298. doi: 10.1007/s12282-016-0703-6. Epub 2016 May 14.</citation>
    <PMID>27179527</PMID>
  </reference>
  <reference>
    <citation>Fuzesi S, Cano SJ, Klassen AF, Atisha D, Pusic AL. Validation of the electronic version of the BREAST-Q in the army of women study. Breast. 2017 Jun;33:44-49. doi: 10.1016/j.breast.2017.02.015. Epub 2017 Mar 7.</citation>
    <PMID>28279888</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Helio Carrara</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>breast cancer, breast surgery, breast reconstruction,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03777852
org study id: Juçara Phd Thesis
secondary id: Helio Carrara
nct id: NCT03777852
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Data from the National Cancer Institute (Inca) reveal that breast cancer is the most common
      type of cancer among women worldwide. In Brazil, it is second only to non-melanoma skin
      cancer. Breast cancer is a feared disease in the female universe because it is considered one
      of the major causes of death due to neoplasia among women. It brings also the stigma of
      suffering, mutilation, loss of female identity and loss of body contour. Among other issues,
      problems with body self-image may have an impact on sexuality and fertility, and also, the
      incapacity to breastfeed. Breast reconstruction can restore the patient's shape and physical
      integrity, among other benefits. The research justifies itself because information about the
      satisfaction of breast reconstruction can be achieved. It is also known that women having
      breast reconstruction after a mastectomy due to cancer have a favorable evolution. This study
      will analyze body contour satisfaction of women undergoing mastectomy and breast
      reconstruction as part of their breast cancer treatment. The Breast Q questionnaire will be
      used to measure patients satisfaction.
This is a prospective, quasi-experimental study. The subject sample will be composed of women
      submitted to mastectomy due to breast cancer and to breast reconstruction as part of their
      treatment. They will be evaluated twice. One when they receive the cancer diagnosis and the
      other six months after de reconstruction surgery. On both occasions, they will answer the
      Brest Q questionnaire.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: A group of women will be evaluated twice, being one before the intervention and the second after the breast cancer reconstruction surgery
primary purpose: Other
masking: Single (Participant)
measure: Post-treatment Satisfaction
time frame: Six month
description: Comparison of results between the first and the second Breast Q score. This score represents questionnaries about diferents domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).
arm group label: Pre-surgery First Breast Q
arm group type: Experimental
description: Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..
arm group label: Post-surgery Second Breast Q
arm group type: Active Comparator
description: The Second Breast Q questionnaire will be applied to this group that will be composed of the women of the first group submitted to reconstructive breast cancer surgery.
intervention type: Diagnostic Test
intervention name: First Questionnaire application
description: Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.
arm group label: Pre-surgery First Breast Q
other name: First Breast Q questionnaire
intervention type: Diagnostic Test
intervention name: Second Questionnaire application
description: Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.
arm group label: Post-surgery Second Breast Q
other name: Post reconstruction breast cancer
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Helio HA Carrara, MD, PhD
role: Principal Investigator
affiliation: Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP.
last name: Helio HA Carrara, MD, PhD
phone: 551636021000
phone ext: 2589
email: carrara@fmrp.usp.br
last name: Francisco JC Reis, MD, PhD
phone: 551636022589
email: fjcreis@fmrp.usp.br
facility: 
country: Brazil
citation: Cohen WA, Mundy LR, Ballard TN, Klassen A, Cano SJ, Browne J, Pusic AL. The BREAST-Q in surgical research: A review of the literature 2009-2015. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):149-62. doi: 10.1016/j.bjps.2015.11.013. Epub 2015 Nov 26.
PMID: 26740288
citation: Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PMID: 19644246
citation: Mundy LR, Homa K, Klassen AF, Pusic AL, Kerrigan CL. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2017 May;139(5):1046e-1055e. doi: 10.1097/PRS.0000000000003241.
PMID: 28445351
citation: Payne RM, Siotos C, Manahan MA, Rosson GD, Cooney CM. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2018 Jan;141(1):180e-181e. doi: 10.1097/PRS.0000000000003970. No abstract available.
PMID: 28938344
citation: Saiga M, Taira N, Kimata Y, Watanabe S, Mukai Y, Shimozuma K, Mizoo T, Nogami T, Iwamoto T, Motoki T, Shien T, Matsuoka J, Doihara H. Development of a Japanese version of the BREAST-Q and the traditional psychometric test of the mastectomy module for the assessment of HRQOL and patient satisfaction following breast surgery. Breast Cancer. 2017 Mar;24(2):288-298. doi: 10.1007/s12282-016-0703-6. Epub 2016 May 14.
PMID: 27179527
citation: Fuzesi S, Cano SJ, Klassen AF, Atisha D, Pusic AL. Validation of the electronic version of the BREAST-Q in the army of women study. Breast. 2017 Jun;33:44-49. doi: 10.1016/j.breast.2017.02.015. Epub 2017 Mar 7.
PMID: 28279888
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Helio Carrara
investigator title: Principal Investigator
mesh term: Neoplasms
mesh term: Breast Neoplasms
sharing ipd: No