CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
Decision Support Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06161181
NCT06161181N/ACompleted

Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients: the Study Protocol

European Institute of Oncology·interventional·Posted Dec 7, 2023·Updated Oct 15, 2024

In Brief

A clinical study evaluating Decision Support System for Metastatic Breast Cancer. Completed, enrolled 94 participants across 1 site.

Detailed Summary

Background: Emerging evidence indicates that patients with advanced cancer, such as those with MBC, often exhibit significant levels of nonadherence to oral anticancer treatments. Leveraging of the machine learning models in clinical practice enables the provision of personalized predictions on medication adherence for individual patients, thereby supporting adherence and facilitating targeted interventions. Objective: The current protocol aims to assess the efficacy of the DSS, a web-based solution named TREAT (TREatment Adherence SupporT), and a machine learning web application in promoting adherence to oral anticancer treatments within a sample of MBC patients. Methods and Design: This protocol is part of a project titled "Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients" (Tracking Number 65080791). A sample of 100 MBC patients is enrolled consecutively and admitted to the Division of Medical Senology of the European Institute of Oncology. 50 MBC patients receive the DSS for three months (experimental group), while 50 MBC patients not subjected to the intervention receive standard medical advice (control group). The protocol foresees three assessment time points: T1 (1-Month), T2 (2-Month), and T3 (3-Month). At each time point, participants fill out a set of self-reports evaluating adherence, clinical, psychological, and QoL variables. Conclusions: our results will inform about the effectiveness of the DSS and risk-predictive models in fostering adherence to oral anticancer treatments in MBC patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsPfizer

Timeline

N/ACompletedFinished
202420252026
First PostedDec 7, 2023
Enrollment StartMay 3, 2023
Primary CompletionFeb 15, 2024
Study CompletionMay 15, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.6 years ago

Interventions

Decision Support Systemdevice

TREAT (TREatment Adherence SupporT) is a web-based DSS that comprises four sections: i) Metastatic Breast Cancer: contains information about MBC and its physical and psychological consequences; ii) Adherence to Cancer Therapies: contains information about adherence in the cancer population; iii) Promoting Adherence: contains information about resources, barriers, and available interventions used to foster adherence; iv) My Adherence Diary.