Factors Influencing Adherence to Adjuvant Endocrine Therapy

Adherence, Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192446
• Other study ID #: 380-130/134-22-4
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Adherence, Treatment

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.