Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, Oral Anticancer Agents, Oral Medication Adherence
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).
Interventions
BEHAVIORALStandard care
Patient will not receive any additional interventions
BEHAVIORALDecision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
BEHAVIORALReminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
BEHAVIORALFeedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to oral medication | 7 months | Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Contacts
Primary ContactGabriella Pravettoni, MD
Backup ContactMara Negri
Outcome results
None listed