Emotional Evaluation and Reconstructed Breast Satisfaction

Malignant Neoplasm of the Breast Clinical Trial

Official title:

Emotional Evaluation and Reconstructed Breast Satisfaction After Breast Cancer Treatment: Breast Q Questionary

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03777852
• Other study ID #: Juçara Phd Thesis
• Secondary ID: Helio Carrara
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2018
• Source: University of Sao Paulo
• Contact: Helio HA Carrara, MD, PhD
• Phone: 551636021000
• Email: carrara[@]fmrp.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• women over eighteen years of age;

• 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 diagnosed with breast cancer and treated with conservative surgeries;

• women who refuse reconstruction as part of treatment;

• women who refused surgery as part of the treatment for breast cancer

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Neoplasm of the Breast
• Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Ribeirão Preto	Ribeirão Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. Review. — View 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. — View 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. — View 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. — View 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):345-53. doi: 10.1097/PRS.0b013e3181aee807. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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