Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients
NCT ID: NCT06726889
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
104 participants
OBSERVATIONAL
2024-01-25
2025-04-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard Care + DSS + Reminders + Feedback
Patients will receive educational material through a web-page, personalized reminders and feedback messages by physician
Standard care
Patient will not receive any additional interventions
Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Standard Care + DSS + Reminders
Patients will receive educational material through a web-page and personalized reminders
Standard care
Patient will not receive any additional interventions
Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Standard Care + DSS + Feedback
Patients will receive educational material through a web-page and feedback messages by physician
Standard care
Patient will not receive any additional interventions
Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Standard Care + DSS
Patients will receive educational material through a web-page
Standard care
Patient will not receive any additional interventions
Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Standard Care + Reminders + Feedback
Patients will receive personalized reminders and feedback messages by physician
Standard care
Patient will not receive any additional interventions
Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Standard Care + Reminders
Patients will receive personalized reminders
Standard care
Patient will not receive any additional interventions
Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Standard Care + Feedback
Patients will receive feedback messages by physician
Standard care
Patient will not receive any additional interventions
Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Standard Care
Patient will not receive any additional interventions
Standard care
Patient will not receive any additional interventions
Interventions
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Standard care
Patient will not receive any additional interventions
Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Eligibility Criteria
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Inclusion Criteria
* 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
* Comorbidity that may impact on compliance to study procedures
18 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Gabriella Pravettoni, MD
Role: PRINCIPAL_INVESTIGATOR
European Istitute of Oncology
Locations
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European Institute of Oncology
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Gabriella Pravettoni, MD
Role: primary
Other Identifiers
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IEO 2014
Identifier Type: -
Identifier Source: org_study_id