Adherence, TreatmentNCT06192446
Factors Influencing Adherence to Adjuvant Endocrine Therapy
An observational study of Adherence, Treatment, run by University of Zagreb at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adherence, Treatment
- What is being tested?
- Survey using a questionnaire.
- How many people
- 1,000 participants
- Where
- 1 siteCroatia
- Study dates
- 20 Sep 2021to 20 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University of Zagreb Faculty of Pharmacy and Biochemistry
Zagreb, 10000
Iva Mucalo, +3851 6461 802, imucalo@pharma.hr
Centre for Applied Pharmacy, +38516394 411, cpf@pharma.hr
About this study
Official title: 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.
- Conditions
- Adherence, Treatment
- Being tested
- Survey using a questionnaire.
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Drug
An observational study conducted in a cross-sectional manner using a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1.
Secondary outcomes (2)
Beliefs About Medicines
Investigate medication beliefs using the Medication Beliefs Questionnaire (BMQ).
Measured: 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).
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Sep 2021
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iva Mucalo, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192446
- Sponsor's protocol ID
- 380-130/134-22-4
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Adherence to Adjuvant Endocrine Therapy in Women With Early Breast Cancer in Croatia
- ClinicalTrials.gov ID
- NCT06192446
- Acronym / sponsor ID
- 380-130/134-22-4
- Conditions
- Adherence, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with hormone-sensitive early breast cancer | – | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey using a questionnaire.An observational study conducted in a cross-sectional manner using a questionnaire. | Drug | Women with hormone-sensitive early breast cancer |
Primary outcome
Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy
Time frame: 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.
2 secondary outcomes
Beliefs About Medicines
Time frame: Day 1.
Prevalence of Treatment-Emergent Adverse Events as assessed by FACT-ES
Time frame: Day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence, Treatment, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iva Mucalo (+3851 6461 802, imucalo@pharma.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence to adjuvant endocrine therapy assessment: Measurement of the level of adherence to adjuvant endocrine therapy (time frame: Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.