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.
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 Type
OBSERVATIONAL
Enrollment
104
Patient will not receive any additional interventions
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
European Institute of Oncology
Milan, Italy
RECRUITINGAdherence to oral medication
Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed
Time frame: 7 months
Depressive symptoms evaluation
Collection of Beck Depression Inventory II (BDI-II) questionnaire (minimum value: 0, maximum value: 3 - higher scores mean greater depression)
Time frame: 7 months
Anxiety evaluation
Collection of State-Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
Time frame: 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)
Time frame: 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)
Time frame: 7 months
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Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision