Clinical trial

Factors Influencing Adherence to Adjuvant Endocrine Therapy in Women With Early Breast Cancer in Croatia

Name
380-130/134-22-4
Description
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.
Trial arms
Trial start
2021-09-20
Estimated PCD
2024-09-20
Trial end
2024-09-20
Status
Recruiting
Treatment
Survey using a questionnaire.
An observational study conducted in a cross-sectional manner using a questionnaire.
Arms:
Women with hormone-sensitive early breast cancer
Size
1000
Primary endpoint
Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy
Day 1.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2024-01-11

1 organization

1 product

2 indications

Indication
Adherence
Indication
Therapy