Emotional Evaluation and Reconstructed Breast Satisfaction After Breast Cancer Treatment: Breast Q Questionary
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Post-treatment Satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pre-surgery First Breast Q
Women with proven breast cancer diagnosis. Respond to the First Breast Q questionnaire..
干预措施: First Questionnaire application (Diagnostic Test)
Post-surgery Second Breast Q
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.
干预措施: Second Questionnaire application (Diagnostic Test)
结局指标
主要结局
Post-treatment Satisfaction
时间窗: 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).
次要结局
未报告次要终点
研究者
Helio Carrara
Principal Investigator
University of Sao Paulo