Breast CancerNCT06726889
Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Aim of this study is to optimize an adherence increasing intervention designed for metastatic Breast Cancer (BC) patients by applying a full factorial design in order to evaluate the optimal combination of three different intervention components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Decision Support System (DSS), Reminders and Feedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic breast cancer patients with a prescription for any Oral Anticancer Agent
Who may be able to join
- Patients with a diagnosis of metastatic BC
- Patients with a prescription for any OAA (i.e. oral chemotherapy, endocrine therapy, and Cyclin-Dependent Kinase 4/6 Inhibitors)
- Age >18 years old
- Patients with a personal smart phone with internet access
- Willingness and ability to comply with scheduled visits and other trial procedures
- Understanding and speaking Italian language
- Written informed consent
Who cannot join
- Psychiatric disorders or conditions that might impair the ability to give informed consent
- Comorbidity that may impact on compliance to study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Gabriella Pravettoni, MD, +39 0257489731, gabriella.pravettoni@ieo.it
About this study
Official title: Optimizing an Intervention to Increase Oral Medication Adherence for Metastatic Breast Cancer Patients
Aim of this study is to optimize an adherence increasing intervention designed for metastatic Breast Cancer (BC) patients by applying a full factorial design in order to evaluate the optimal combination of three different intervention components.
Read the detailed description
Today different types of Oral Anticancer Agents (OAA) are commonly prescribed to Breast Cancer (BC) patients. Patients are reported to prefer the oral modality of administration over the intravenous one for its convenience, flexibility, and easier assumption; nonetheless, the phenomenon of medication non-adherence is well-documented.
Although several interventions have been designed and tested in order to foster medication adherence among BC patients, the great majority of them were focused on adherence to endocrine therapy for early-stage BC patients, with only few exceptions involving metastatic BC patients or considering adherence to other types of OAA.
The aim of this work is to optimize an adherence increasing intervention designed for metastatic BC patients. This will be achieved by applying a full factorial design in order to evaluate the optimal combination of three different intervention components (informative documentation, personalized reminders and feedback).
- Conditions
- Breast Cancer
- Being tested
- Standard care, Decision Support System (DSS), Reminders, Feedback
- Keywords
- Metastatic Breast Cancer, Oral Anticancer Agents, Oral Medication Adherence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careBehavioural
Patient will not receive any additional interventions
Decision Support System (DSS)Behavioural
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
RemindersBehavioural
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
FeedbackBehavioural
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
| Study group | Role | What they receive |
|---|---|---|
| Standard Care + DSS + Reminders + Feedback | Patients will receive educational material through a web-page, personalized reminders and feedback messages by physician Receives: Behavioral: Standard care; Behavioral: Decision Support System (DSS); Behavioral: Reminders; Behavioral: Feedback | |
| Standard Care + DSS + Reminders | Patients will receive educational material through a web-page and personalized reminders Receives: Behavioral: Standard care; Behavioral: Decision Support System (DSS); Behavioral: Reminders | |
| Standard Care + DSS + Feedback | Patients will receive educational material through a web-page and feedback messages by physician Receives: Behavioral: Standard care; Behavioral: Decision Support System (DSS); Behavioral: Feedback | |
| Standard Care + DSS | Patients will receive educational material through a web-page Receives: Behavioral: Standard care; Behavioral: Decision Support System (DSS) | |
| Standard Care + Reminders + Feedback | Patients will receive personalized reminders and feedback messages by physician Receives: Behavioral: Standard care; Behavioral: Reminders; Behavioral: Feedback | |
| Standard Care + Reminders | Patients will receive personalized reminders Receives: Behavioral: Standard care; Behavioral: Reminders | |
| Standard Care + Feedback | Patients will receive feedback messages by physician Receives: Behavioral: Standard care; Behavioral: Feedback | |
| Standard Care | Patient will not receive any additional interventions Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to oral medication
Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed
Measured: 7 months
Secondary outcomes (4)
Depressive symptoms evaluation
Collection of Beck Depression Inventory II (BDI-II) questionnaire (minimum value: 0, maximum value: 3 - higher scores mean greater depression)
Measured: 7 months
Anxiety evaluation
Collection of State-Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
Measured: 7 months
Quality of life evaluation
Completion of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC-QLQ-C30 (minimum value: 1, maximum value: 4 - higher scores mean a greater agreement with the statement)
Measured: 7 months
Health-related quality of life evaluation
Completion of European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC-QLQ-BR23) (minimum value: 1, maximum value: 4 - higher scores mean a greater agreement with the statement)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start25 Jan 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726889
- Sponsor's protocol ID
- IEO 2014
- Status last verified
- Nov 2024
- First submitted
- 5 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing an Intervention to Increase Oral Medication Adherence for Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06726889
- Acronym / sponsor ID
- IEO 2014
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, Oral Anticancer Agents, Oral Medication Adherence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 10 Dec 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.
Aim of this study is to optimize an adherence increasing intervention designed for metastatic Breast Cancer (BC) patients by applying a full factorial design in order to evaluate the optimal combination of three different intervention components.
Detailed description
Today different types of Oral Anticancer Agents (OAA) are commonly prescribed to Breast Cancer (BC) patients. Patients are reported to prefer the oral modality of administration over the intravenous one for its convenience, flexibility, and easier assumption; nonetheless, the phenomenon of medication non-adherence is well-documented.
Although several interventions have been designed and tested in order to foster medication adherence among BC patients, the great majority of them were focused on adherence to endocrine therapy for early-stage BC patients, with only few exceptions involving metastatic BC patients or considering adherence to other types of OAA.
The aim of this work is to optimize an adherence increasing intervention designed for metastatic BC patients. This will be achieved by applying a full factorial design in order to evaluate the optimal combination of three different intervention components (informative documentation, personalized reminders and feedback).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Standard Care + DSS + Reminders + Feedback | – | Behavioral: Standard care, Behavioral: Decision Support System (DSS), Behavioral: Reminders, Behavioral: FeedbackPatients will receive educational material through a web-page, personalized reminders and feedback messages by physician |
| Standard Care + DSS + Reminders | – | Behavioral: Standard care, Behavioral: Decision Support System (DSS), Behavioral: RemindersPatients will receive educational material through a web-page and personalized reminders |
| Standard Care + DSS + Feedback | – | Behavioral: Standard care, Behavioral: Decision Support System (DSS), Behavioral: FeedbackPatients will receive educational material through a web-page and feedback messages by physician |
| Standard Care + DSS | – | Behavioral: Standard care, Behavioral: Decision Support System (DSS)Patients will receive educational material through a web-page |
| Standard Care + Reminders + Feedback | – | Behavioral: Standard care, Behavioral: Reminders, Behavioral: FeedbackPatients will receive personalized reminders and feedback messages by physician |
| Standard Care + Reminders | – | Behavioral: Standard care, Behavioral: RemindersPatients will receive personalized reminders |
| Standard Care + Feedback | – | Behavioral: Standard care, Behavioral: FeedbackPatients will receive feedback messages by physician |
| Standard Care | – | Behavioral: Standard carePatient will not receive any additional interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic breast cancer patients with a prescription for any Oral Anticancer Agent
Key inclusion criteria (7 listed)
- Patients with a diagnosis of metastatic BC
- Patients with a prescription for any OAA (i.e. oral chemotherapy, endocrine therapy, and Cyclin-Dependent Kinase 4/6 Inhibitors)
- Age >18 years old
- Patients with a personal smart phone with internet access
- Willingness and ability to comply with scheduled visits and other trial procedures
Key exclusion criteria (2 listed)
- Psychiatric disorders or conditions that might impair the ability to give informed consent
- Comorbidity that may impact on compliance to study procedures
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 |
|---|---|---|
| Standard carePatient will not receive any additional interventions | Behavioural | Standard Care, Standard Care + DSS, Standard Care + DSS + Feedback, Standard Care + DSS + Reminders, Standard Care + DSS + Reminders + Feedback, Standard Care + Feedback, Standard Care + Reminders, Standard Care + Reminders + Feedback |
| Decision Support System (DSS)DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link | Behavioural | Standard Care + DSS, Standard Care + DSS + Feedback, Standard Care + DSS + Reminders, Standard Care + DSS + Reminders + Feedback |
| RemindersPersonalized reminders will be delivered to patients through a common messaging application (WhatsApp) | Behavioural | Standard Care + DSS + Reminders, Standard Care + DSS + Reminders + Feedback, Standard Care + Reminders, Standard Care + Reminders + Feedback |
| FeedbackFeedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision | Behavioural | Standard Care + DSS + Feedback, Standard Care + DSS + Reminders + Feedback, Standard Care + Feedback, Standard Care + Reminders + Feedback |
Primary outcome
Adherence to oral medication
Time frame: 7 months
Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed
4 secondary outcomes
Depressive symptoms evaluation
Time frame: 7 months
Anxiety evaluation
Time frame: 7 months
Quality of life evaluation
Time frame: 7 months
Health-related quality of life evaluation
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Gabriella Pravettoni, MD principal investigator
European Istitute of Oncology
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 Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Dec 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Pravettoni, MD (+39 0257489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to oral medication (time frame: 7 months). 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 20 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.