Emotional Evaluation and Reconstructed Breast Satisfaction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malignant Neoplasm of the Breast

Intervention / Treatment
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* Diagnostic Test: First Questionnaire application
* Diagnostic Test: Second Questionnaire application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A group of women will be evaluated twice, being one before the intervention and the second after the breast cancer reconstruction surgery
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-surgery First Breast Q<br>Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire.. | Diagnostic Test: First Questionnaire application<br>* Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.<br>* Other names: First Breast Q questionnaire;|
| Active Comparator: Post-surgery Second Breast Q<br>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. | Diagnostic Test: Second Questionnaire application<br>* Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.<br>* Other names: Post reconstruction breast cancer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, breast surgery, breast reconstruction,