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| ID | Type | Description | Link |
|---|---|---|---|
| Helio Carrara | Other Identifier | DGO-FMRP-USP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-surgery First Breast Q | Experimental | Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire.. |
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| Post-surgery Second Breast Q | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First Questionnaire application | Diagnostic Test | Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment Satisfaction | 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). | Six month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helio HA Carrara, MD, PhD | Contact | 551636021000 | 2589 | carrara@fmrp.usp.br |
| Francisco JC Reis, MD, PhD | Contact | 551636022589 | fjcreis@fmrp.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Helio HA Carrara, MD, PhD | Gynecology & Obstetrics Departament, Ribeirão Preto Medical School, USP. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas de Ribeirão Preto | Ribeirão Preto | São Paulo | 14048900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26740288 | Background | 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. | |
| 19644246 | Background | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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A group of women will be evaluated twice, being one before the intervention and the second after the breast cancer reconstruction surgery
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| Second Questionnaire application | Diagnostic Test | Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery. |
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| 28445351 | Background | 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. |
| 28938344 | Background | 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. |
| 27179527 | Background | 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. |
| 28279888 | Background | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |