European Institute of Oncology
Milan, 20141, Italy
Location status: Recruiting
NCT Number: NCT06726889
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milan, 20141, Italy
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Time frame: 7 months
Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed
Time frame: 7 months
Collection of Beck Depression Inventory II (BDI-II) questionnaire (minimum value: 0, maximum value: 3 - higher scores mean greater depression)
Time frame: 7 months
Collection of State-Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
Time frame: 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)
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Gabriella Pravettoni, MD
CONTACT
Mara Negri
CONTACT
European Institute of Oncology
Other
Optimizing an Intervention to Increase Oral Medication Adherence for Metastatic Breast Cancer Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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