Clinical trial NCT06192446: Factors Influencing Adherence to Adjuvant Endocrine Therapy
Official title: Factors Influencing Adherence to Adjuvant Endocrine Therapy in Women With Early Breast Cancer in Croatia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adherence, Treatment
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises women aged 18 and older who have been diagnosed with hormone-dependent breast cancer at stages 0-III, as per the American Joint Committee on Cancer (AJCC) classification. These women have been receiving adjuvant endocrine therapy for a duration exceeding 3 months.

Brief summary: 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.


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

Primary outcomes:
measure: Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy
timeFrame: Day 1.
Secondary outcomes:
measure: Beliefs About Medicines
timeFrame: Day 1.
measure: Prevalence of Treatment-Emergent Adverse Events as assessed by FACT-ES
timeFrame: Day 1.
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University of Zagreb Faculty of Pharmacy and Biochemistry
Study officials:
References: