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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care + DSS + Reminders + Feedback | Patients will receive educational material through a web-page, personalized reminders and feedback messages by physician |
| |
| Standard Care + DSS + Reminders | Patients will receive educational material through a web-page and personalized reminders |
| |
| Standard Care + DSS + Feedback | Patients will receive educational material through a web-page and feedback messages by physician |
| |
| Standard Care + DSS | Patients will receive educational material through a web-page |
| |
| Standard Care + Reminders + Feedback | Patients will receive personalized reminders and feedback messages by physician |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Behavioral | Patient will not receive any additional interventions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to oral medication | Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms evaluation | Collection of Beck Depression Inventory II (BDI-II) questionnaire (minimum value: 0, maximum value: 3 - higher scores mean greater depression) | 7 months |
| Anxiety evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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Metastatic breast cancer patients with a prescription for any Oral Anticancer Agent
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Pravettoni, MD | Contact | +39 0257489731 | gabriella.pravettoni@ieo.it | |
| Mara Negri | Contact | +39 0257489536 | mara.negri@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Gabriella Pravettoni, MD | European Istitute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care + Reminders | Patients will receive personalized reminders |
|
| Standard Care + Feedback | Patients will receive feedback messages by physician |
|
| Standard Care | Patient will not receive any additional interventions |
|
| Decision Support System (DSS) | Behavioral | DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link |
|
| Reminders | Behavioral | Personalized reminders will be delivered to patients through a common messaging application (WhatsApp) |
|
| Feedback | Behavioral | Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision |
|
Collection of State-Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
| 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) | 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) | 7 months |
| D017437 |
| Skin and Connective Tissue Diseases |