NCT06161181Completed
Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients
Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients: the Study Protocol
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 30 Nov 2023
- Start date
- 3 May 2023
- Primary completion date
- 15 Feb 2024
- Lead sponsor
- European Institute of Oncology
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06161181
What you commit to
- Study type: Interventional
- Participants enrolled: 94
- From 3 May 2023 to the primary completion date, 15 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of primary psychiatric or neurological conditions;
Other
- Patients who refused to sign the informed consent.
Who the study is looking for
- Patients \> 18 years-old;
- Having a metastatic breast cancer diagnosis;
- Taking oral treatment intervention for metastatic breast cancer;
- Patients with internet access and a personal smartphone or tablet;
- Patients who have read and signed the informed consent.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| European Institute fo Oncology Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.