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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06192446
Other study ID # 380-130/134-22-4
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2021
Est. completion date September 20, 2024

Study information

Verified date January 2024
Source University of Zagreb
Contact Iva Mucalo
Phone +3851 6461 802
Email imucalo@pharma.hr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date September 20, 2024
Est. primary completion date September 20, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Survey using a questionnaire.
An observational study conducted in a cross-sectional manner using a questionnaire.

Locations

Country Name City State
Croatia University of Zagreb Faculty of Pharmacy and Biochemistry Zagreb

Sponsors (1)

Lead Sponsor Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary Beliefs About Medicines Investigate medication beliefs using the Medication Beliefs Questionnaire (BMQ). Day 1.
Secondary 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). Day 1.
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