Factors Influencing Adherence to Adjuvant Endocrine Therapy

Recruiting

• Conditions: Adherence, Treatment
• Interventions: Drug: Survey using a questionnaire.

• Registration Number: NCT06192446
• Lead Sponsor: University of Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-20
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-20
• Status Verified: 2024-01
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Primary Completion: 2024-09-20
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with hormone-sensitive early breast cancer	Survey using a questionnaire.	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.

Primary Outcome Measures

Name	Time	Method
Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy	Day 1.	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Treatment-Emergent Adverse Events as assessed by FACT-ES	Day 1.	Examine the quality of life using the Quality of Life Questionnaire with endocrine symptoms (FACT-ES).
Beliefs About Medicines	Day 1.	Investigate medication beliefs using the Medication Beliefs Questionnaire (BMQ).

Trial Locations

Locations (1)

University of Zagreb Faculty of Pharmacy and Biochemistry; 🇭🇷 Zagreb, Croatia