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Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients

NCT06161181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Decision Support System

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Gabriella pravettoni, PhD · Istituto Europeo di Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2024-02-15
Completion
2024-05-15

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161181 on ClinicalTrials.gov