Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients

European Institute of Oncology

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Reminders; Behavioral: Standard care; Behavioral: Feedback; Behavioral: Decision Support System (DSS)

Study type: Observational

Funder types: Other

Identifiers

NCT06726889

IEO 2014

Details and patient eligibility

About

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.

Full 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).

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

104 participants in 8 patient groups

Standard Care + DSS + Reminders + Feedback

Description:

Patients will receive educational material through a web-page, personalized reminders and feedback messages by physician

Treatment:

Behavioral: Decision Support System (DSS)

Behavioral: Feedback

Behavioral: Standard care

Behavioral: Reminders

Standard Care + DSS + Reminders

Description:

Patients will receive educational material through a web-page and personalized reminders

Treatment:

Behavioral: Decision Support System (DSS)

Behavioral: Standard care

Behavioral: Reminders

Standard Care + DSS + Feedback

Description:

Patients will receive educational material through a web-page and feedback messages by physician

Treatment:

Behavioral: Decision Support System (DSS)

Behavioral: Feedback

Behavioral: Standard care

Standard Care + DSS

Description:

Patients will receive educational material through a web-page

Treatment:

Behavioral: Decision Support System (DSS)

Behavioral: Standard care

Standard Care + Reminders + Feedback

Description:

Patients will receive personalized reminders and feedback messages by physician

Treatment:

Behavioral: Feedback

Behavioral: Standard care

Behavioral: Reminders

Standard Care + Reminders

Description:

Patients will receive personalized reminders

Treatment:

Behavioral: Standard care

Behavioral: Reminders

Standard Care + Feedback

Description:

Patients will receive feedback messages by physician

Treatment:

Behavioral: Feedback

Behavioral: Standard care

Standard Care

Description:

Patient will not receive any additional interventions

Treatment:

Behavioral: Standard care