Factors Influencing Adherence to Adjuvant Endocrine Therapy in Women With Early Breast Cancer in Croatia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy
研究概览
简要总结
Breast cancer is the most common type of cancer and the leading cause of cancer death in women. Adjuvant endocrine therapy (AET) reduces the risk of disease recurrence and mortality in women with hormone-dependent breast cancer. This cross-sectional study aims to investigate adherence to AET and identify factors associated with adherence in the Republic of Croatia. The level of adherence, beliefs about medicines, and quality of life with AET will be investigated with validated instruments in the form of an anonymous survey. Given the available data on suboptimal adherence to AET in Europe and globally, it is clear that there is a need for investigating adherence in Croatia which hasn't been done so far. Each country, population, and health system has its own characteristics, and understanding the experience of using AET and identifying associated psychosocial factors could help in developing specific interventions supporting women and improving AET adherence.
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
- •women older than 18 years of age
- •clinical diagnosis of hormone receptor positive early breast cancer stages 0-III according to the American Joint Committee on Cancer (AJCC) classification
- •prescribed with adjuvant endocrine therapy for more than 3 months
排除标准
- •advanced metastatic breast cancer, stage IV according to the American Joint Committee on Cancer (AJCC) classification
- •other life-threatening illnesses
- •mental disorders
- •behavioral disorders caused by the use of psychoactive substances
- •behavioral syndromes related to physiological disorders and physical factors
- •cognitive impairment
- •organic and symptomatic mental disorder
- •schizophrenia
- •disorders similar to schizophrenia
- •delusional disorders
- •personality disorders
- •behavior disorders
- •mental retardation
- •psychological development disorders
- •unspecified mental disorders
- •Incapable of autonomously reaching decisions
研究组 & 干预措施
Women with hormone-sensitive early breast cancer
Women older than 18 years of age who have suffered from hormonally dependent breast cancer stages 0-III (from "in situ" to locally advanced breast cancer) according to the American Joint Committee on Cancer (AJCC) classification and have been undergoing adjuvant endocrine therapy for more than 3 months.
干预措施: Survey using a questionnaire. (Drug)
结局指标
主要结局
Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy
时间窗: Day 1.
The overall aim of the study is to determine the proportion of women adherent to oral adjuvant endocrine therapy (AEL) after the diagnosis of breast cancer in Croatia, as well as to investigate the association between AEL adherence, medication beliefs, quality of life, sociodemographic, and clinical factors.
次要结局
- Prevalence of Treatment-Emergent Adverse Events as assessed by FACT-ES(Day 1.)
- Beliefs About Medicines(Day 1.)
研究者
Iva Mucalo
Associate professor at the Center for Applied Pharmacy.
University of Zagreb