Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06726889
• Lead Sponsor: European Institute of Oncology

Brief 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.

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 Timeline

• Study Start: 2024-01-25
• Status Verified: 2024-11
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to oral medication	7 months	Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms evaluation	7 months	Collection of Beck Depression Inventory II (BDI-II) questionnaire (minimum value: 0, maximum value: 3 - higher scores mean greater depression)
Anxiety evaluation	7 months	Collection of State-Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
Quality of life evaluation	7 months	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)
Health-related quality of life evaluation	7 months	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)

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy