Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)
研究概览
简要总结
Breast cancer directly affects women physically, psychologically and socially in the process of diagnosis, treatment and post-treatment. Despite the improvement in conventional breast cancer treatments that led to longer disease-free survival, many patients still suffer from physical, psychological, social and spiritual problems after treatment. The neglect of physical and psychosocial problems faced by patients who are between 1 and 2 years after the end of treatment negatively impacts the quality of life of this population.
详细描述
The purpose of the study is to assess the overall quality of life and measure the impact on women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment and to identify possible repercussions of breast cancer and its treatments associated with Quality of Life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer
- •Adult women (age ≥ 20 years old and less than 60 years old)
- •Patient who has been treated by surgery, with or without adjuvant chemotherapy
- •Clinical Stages I, II and III
- •Patients considered cured, without history of recurrences
- •Patients who completed treatment within a minimum of 1 year and are currently being undergoing outpatient follow-up
排除标准
- •Initial diagnosis of another type of cancer, other than breast cancer
- •Bilateral breast cancer
- •Patient unable to fill out the QoL questionnaire
- •Patient with disease recurrence
- •Patient with metastatic breast cancer
结局指标
主要结局
Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)
时间窗: 1 year after treatment ends; 2 years after treatment ends;
This questionnaire was designed to be cancer specific, and includes all emotional, social and physical aspects of the individual's life. The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.
次要结局
- Quality of life specific for breast cancer by EORTC QLQ-BR23 (European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire)(1 year after treatment ends; 2 years after treatment ends;)
- Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast)(1 year after treatment ends; 2 years after treatment ends;)
研究者
Thiago Vidal Brito
Principal Investigator
Instituto Brasileiro de Controle do Cancer