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Clinical Trials/NCT03777852
NCT03777852
Unknown
Not Applicable

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

University of Sao Paulo1 site in 1 country110 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Neoplasm of the Breast
Sponsor
University of Sao Paulo
Enrollment
110
Locations
1
Primary Endpoint
Post-treatment Satisfaction
Last Updated
7 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
February 28, 2022
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Helio Carrara

Principal Investigator

University of Sao Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Post-treatment Satisfaction

Time Frame: Six month

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).

Study Sites (1)

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