Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard care, Decision Support System (DSS), Reminders, Feedback.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing an Intervention to Increase Oral Medication Adherence for Metastatic Breast Cancer Patients
Overview
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).
Interventions
- Behavioral Standard care
Patient will not receive any additional interventions - Behavioral Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link - Behavioral Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp) - Behavioral Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Primary outcome measures
- Adherence to oral medication [Time frame: 7 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Psychiatric disorders or conditions that might impair the ability to give informed consent
- Comorbidity that may impact on compliance to study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Identifiers
NCT: NCT06726889 · IEO 2014