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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey using a questionnaire. | Drug | An observational study conducted in a cross-sectional manner using a questionnaire. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy | 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. | Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Beliefs About Medicines | Investigate medication beliefs using the Medication Beliefs Questionnaire (BMQ). | Day 1. |
| Prevalence of Treatment-Emergent Adverse Events as assessed by FACT-ES | Examine the quality of life using the Quality of Life Questionnaire with endocrine symptoms (FACT-ES). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iva Mucalo | Contact | +3851 6461 802 | imucalo@pharma.hr | |
| Faculty of Pharmacy and Biochemistry | Contact | +3851 6394 411 | cpf@pharma.hr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zagreb Faculty of Pharmacy and Biochemistry | Recruiting | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Day 1. |