Factors Influencing Adherence to Adjuvant Endocrine Therapy

University of Zagreb

Status: Enrolling

Conditions: Adherence, Treatment

Treatments: Drug: Survey using a questionnaire.

Study type: Observational

Funder types: Other

Identifiers

NCT06192446

380-130/134-22-4

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Women with hormone-sensitive early breast cancer

Description:

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.

Treatment:

Drug: Survey using a questionnaire.