Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients

December 17, 2024 updated by: European Institute of Oncology

Optimizing an Intervention to Increase Oral Medication Adherence for Metastatic Breast Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Metastatic breast cancer patients with a prescription for any Oral Anticancer Agent

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard Care + DSS + Reminders
Patients will receive educational material through a web-page and personalized reminders
Behavioral: Standard care
Patient will not receive any additional interventions
Behavioral: Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Behavioral: Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Standard Care + DSS
Patients will receive educational material through a web-page
Behavioral: Standard care
Patient will not receive any additional interventions
Behavioral: Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Standard Care + Reminders
Patients will receive personalized reminders
Behavioral: Standard care
Patient will not receive any additional interventions
Behavioral: Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Standard Care
Patient will not receive any additional interventions
Behavioral: Standard care
Patient will not receive any additional interventions
Standard Care + DSS + Reminders + Feedback
Patients will receive educational material through a web-page, personalized reminders and feedback messages by physician
Behavioral: Standard care
Patient will not receive any additional interventions
Behavioral: Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Behavioral: Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Behavioral: Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Standard Care + DSS + Feedback
Patients will receive educational material through a web-page and feedback messages by physician
Behavioral: Standard care
Patient will not receive any additional interventions
Behavioral: Decision Support System (DSS)
DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link
Behavioral: Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Standard Care + Reminders + Feedback
Patients will receive personalized reminders and feedback messages by physician
Behavioral: Standard care
Patient will not receive any additional interventions
Behavioral: Reminders
Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)
Behavioral: Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision
Standard Care + Feedback
Patients will receive feedback messages by physician
Behavioral: Standard care
Patient will not receive any additional interventions
Behavioral: Feedback
Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to oral medication
Time Frame: 7 months
Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms evaluation
Time Frame: 7 months
Collection of Beck Depression Inventory II (BDI-II) questionnaire (minimum value: 0, maximum value: 3 - higher scores mean greater depression)
7 months
Anxiety evaluation
Time Frame: 7 months
Collection of State-Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)
7 months
Health-related quality of life evaluation
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)
7 months
Quality of life evaluation
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)
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Gabriella Pravettoni, MD, European Istitute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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