Factors Influencing Adherence to Adjuvant Endocrine Therapy

NCT ID: NCT06192446

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-20

Study Completion Date

2024-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adherence, Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Survey using a questionnaire.

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Survey using a questionnaire.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Iva Mucalo

Associate professor at the Center for Applied Pharmacy.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Zagreb Faculty of Pharmacy and Biochemistry

Zagreb, , Croatia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Croatia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Iva Mucalo

Role: CONTACT

+3851 6461 802

Faculty of Pharmacy and Biochemistry

Role: CONTACT

+3851 6394 411

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Iva Mucalo

Role: primary

+3851 6461 802

Centre for Applied Pharmacy

Role: backup

+38516394 411

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

380-130/134-22-4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.