Factors Influencing Adherence to Adjuvant Endocrine Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adherence, Treatment
• Intervention / Treatment: Drug: Survey using a questionnaire.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Iva Mucalo; Phone Number: +3851 6461 802; Email: imucalo@pharma.hr
• Study Contact Backup: Name: Faculty of Pharmacy and Biochemistry; Phone Number: +3851 6394 411; Email: cpf@pharma.hr

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • University of Zagreb Faculty of Pharmacy and Biochemistry
    • Contact: Iva Mucalo; Phone Number: +3851 6461 802; Email: imucalo@pharma.hr
    • Contact: Centre for Applied Pharmacy; Phone Number: +38516394 411; Email: cpf@pharma.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; An observational study conducted in a cross-sectional manner using a questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beliefs About Medicines	Investigate medication beliefs using the Medication Beliefs Questionnaire (BMQ).	Day 1.
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.

Collaborators and Investigators

• Sponsor: University of Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 380-130/134-22-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No