Emotional Evaluation and Reconstructed Breast Satisfaction
NCT ID: NCT03777852
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2019-07-01
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Pre-surgery First Breast Q
Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..
First Questionnaire application
Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.
Post-surgery Second Breast Q
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.
Second Questionnaire application
Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.
Interventions
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First Questionnaire application
Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.
Second Questionnaire application
Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* women with proven histological diagnosis of breast cancer;
* women who have an indication of mastectomy as part of their treatment;
* women who have breast reconstruction, regardless of the technique used, as part of their treatment;
* women under 70 years of age at the time of the reconstructive surgery
Exclusion Criteria
* women who refuse reconstruction as part of treatment;
* women who refused surgery as part of the treatment for breast cancer
18 Years
70 Years
FEMALE
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Helio Carrara
Principal Investigator
Principal Investigators
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Helio HA Carrara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP.
Locations
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Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Helio Carrara
Identifier Type: OTHER
Identifier Source: secondary_id
Juçara Phd Thesis
Identifier Type: -
Identifier Source: org_study_id
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