A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer

Recruiting

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT06343181
• Lead Sponsor: European Institute of Oncology

Brief Summary

Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer.

Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project."

Detailed Description

The aim of this research project is to assess the barriers and resources (both individual and environmental), as well as the psychological, clinical, and contextual factors that may influence adherence to pharmacological therapy in patients with actively treated metastatic breast cancer.

This will be achieved through a qualitative analysis focused on pharmacological therapy and its administration methods.

For this study, 4 focus groups will be conducted to identify the needs, barriers, and psychological, clinical, and contextual factors that may influence adherence to pharmacological treatment in patients with metastatic breast cancer, as well as their preferences regarding these treatments.

The number of focus groups was determined in accordance with recommendations from the literature for identifying relevant themes, which suggest that to achieve an adequate level of saturation, four or more focus groups are necessary.

Study Timeline

• Study Start: 2022-10-03
• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Age over 18 years old;
• Diagnosis of metastatic breast cancer;
• Availability of an internet connection and a PC or Tablet (for remote focus groups);
• Signing of the informed consent.

Exclusion Criteria

• Presence of psychiatric or neurological conditions impairing the ability to comprehend the questions in Focus Groups or to express free consent to participate in the study;
• Presence of medical or oncological conditions other than metastatic breast cancer;
• Refusal to sign the informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of factors influencing patients' adherence to medical therapy	1 month	Collection of data in order to evaluation of factors influencing patient's adherence to medical treatment

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy