Quality of Life of Women With Hormone Receptor-Positive Metastatic Breast Cancer Treated in the First-line Setting: Comparison Between Public and Private Institutions.
试验速览
- 阶段
- 不适用
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Assess the quality of life in breast cancer
研究概览
简要总结
Assess the quality of life in patients with hormone receptor positive, human epidermal growth factor receptor-type 2 negative metastatic breast cancer treated in first line (patients with new metastasis or recurrence during adjuvant endocrine therapy): comparison between public and private institutions. The hypothesis to be evaluated is that patients treated in private institutions have a better quality of life when compared to patients treated in public institutions.
详细描述
The main objective of the study is to assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire) and the EORTC-QLQ-BR23 (EORTC Quality of Life Questionnaire - Breast Cancer) of a patient with metastatic breast cancer hormone receptor positive human epidermal growth factor receptor-type 2 negative receiving treatment in the first-line scenario, comparing public and private institutions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who agree to participate by signing a document of free and informed consent (ICF), indicating that the research participant was informed about all relevant aspects of the study;
- •Female patients ≥ 18 years of age;
- •Patients diagnosed with hormone receptor positive, human epidermal growth factor receptor-type 2 -negative metastatic breast cancer; in first-line treatment (metastatic de novo disease or patients with recurrence during adjuvant endocrine therapy).
- •First-line treatment can be considered as cytotoxic chemotherapy, isolated endocrine therapy or endocrine therapy in combination with 4/6 cyclin inhibitors.
- •Patients on treatment for at least three (3) months and no more than eighteen (18) months.
- •Have performance status Eastern Cooperative Oncology Group (ECOG scale) of 0-
- •Do not present other concomitant neoplasms.
排除标准
- •Patients who refuse to participate.
- •Illiterate patients, with low levels of education or cognitive deficits that make it difficult to answer the questions of the data collection instrument.
- •Patients with life expectancy <3 months.
- •Treatment with any product under investigation during the last 28 days.
结局指标
主要结局
Assess the quality of life in breast cancer
时间窗: Baseline
Assess the quality of life using the EORTC-QLQ-BR 23 (EORTC Quality of Life Questionnaire - Breast Cancer).
Assess the quality of life
时间窗: Baseline
Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)
次要结局
未报告次要终点
研究者
Debora de Melo Gagliato Jardim
MD
Beneficência Portuguesa de São Paulo