- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06343181
A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer
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."
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gabriella Pravettoni
- Phone Number: +390257489731
- Email: gabriella.pravettoni@ieo.it
Study Locations
-
-
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Milan, Italy
- Recruiting
- European Institute of Oncology
-
Contact:
- Gabriella Pravettoni
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Metastatic breast cancer (BC)
Patients with diagnosis of BC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of factors influencing patients' adherence to medical therapy
Time Frame: 1 month
|
Collection of data in order to evaluation of factors influencing patient's adherence to medical treatment
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriella Pravettoni, European Institute of Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEO 1824
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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