Emotional Evaluation and Reconstructed Breast Satisfaction

University of Sao Paulo

Status: Unknown

Conditions: Malignant Neoplasm of the Breast

Treatments: Diagnostic Test: Second Questionnaire application; Diagnostic Test: First Questionnaire application

Study type: Interventional

Funder types: Other

Identifiers

NCT03777852

Juçara Phd Thesis

Helio Carrara (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Pre-surgery First Breast Q

Experimental group

Description:

Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..

Treatment:

Diagnostic Test: First Questionnaire application

Post-surgery Second Breast Q

Active Comparator group

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.

Treatment:

Diagnostic Test: Second Questionnaire application