Clinical trial NCT06726889: Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients
Official title: Optimizing an Intervention to Increase Oral Medication Adherence for Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Metastatic Breast Cancer
Oral Anticancer Agents
Oral Medication Adherence
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic breast cancer patients with a prescription for any Oral Anticancer Agent

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).

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to oral medication
timeFrame: 7 months
Secondary outcomes:
measure: Depressive symptoms evaluation
timeFrame: 7 months
measure: Anxiety evaluation
timeFrame: 7 months
measure: Quality of life evaluation
timeFrame: 7 months
measure: Health-related quality of life evaluation
timeFrame: 7 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Gabriella Pravettoni, MD
role: PRINCIPAL_INVESTIGATOR
References: