Factors Influencing Adherence to Adjuvant Endocrine Therapy

NCT06192446 | Unknown FDA Drug

• 1 other identifier: 380-130/134-22-4
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Beliefs About Medicines

  Day 1.

• Prevalence of Treatment-Emergent Adverse Events as assessed by FACT-ES

  Day 1.

Study Arms (1)

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.

Drug: Survey using a questionnaire.

Interventions

Survey using a questionnaire. DRUG

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

Women with hormone-sensitive early breast cancer

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

University of Zagreb Faculty of Pharmacy and Biochemistry

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Iva Mucalo

CONTACT

+3851 6461 802; imucalo@pharma.hr

Faculty of Pharmacy and Biochemistry

CONTACT

+3851 6394 411; cpf@pharma.hr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor at the Center for Applied Pharmacy.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 5, 2024
• Study Start: September 20, 2021
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CR (1)