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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343181
• Other study ID #: IEO 1824
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Gabriella Pravettoni
• Phone: +390257489731
• Email: gabriella.pravettoni[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of factors influencing patients' adherence to medical therapy	Collection of data in order to evaluation of factors influencing patient's adherence to medical treatment	1 month