A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06683482
• Lead Sponsor: Gilead Sciences

Brief Summary

The main goal of this ethnographic study is to learn a holistic and enriched view of the behaviors, actions, and views of a group of people with advanced breast cancer (ABC) cancer living in Spain. The primary objective of this study is to collect data on the psychosocial needs of (ABC) patients to identify spaces and strategies to improve these needs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Study Start: 2025-02-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Informed consent to individual in the qualitative study and to allow the recording of the interview for analyses purposes (individual and/or caregiver).
2. Women or men (individual and/or caregiver) over 18 years of age.
3. Confirmed diagnosis of triple-negative breast cancer (TNBC), hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-, HER2+ unresectable locally advanced breast cancer (ULABC) or metastatic breast cancer (mBC) (individual).
4. Individuals must have initiated at least the firstline treatment.
5. Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2 (individual).
6. Ability to conduct interviews from home (individual and/or caregiver) or remotely (ie, with technology available for an online interview).

Key

Exclusion Criteria

1. Individual unable to collaborate in the collection of necessary information (alteration in mental status, noncollaboration, limited language comprehension).
2. Individual unable or unwilling to provide informed consent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Responses to the Open-ended questionnaires	Up to 4 weeks	This qualitative ethnographic study will be carried out through the transcriptions of open-ended interviews. The variables of interest will consist of a set of sociodemographic data, as well as results from emotional and psychological.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Responses to the Open-ended Questionnaires Related to Intimacy and Sexuality	Up to 4 weeks
Number of Participants With Responses to the Economic Impact of the Disease	Up to 4 weeks
Number of Participants With Responses Open-ended Interviews to Assess Importance of Hereditary BC, Genetic Testing and Generic Counselling in ABC Patients	Up to 4 weeks
Number of Participants With Responses to the Open-ended interviews to assess the Level of Insight and Opportunities for Access to Clinical Studies to Promote Research and Access to Novel Therapeutic Options	Up to 4 weeks
Number of Participants With Responses to the Open-ended Interviews to Assess Whether There is any Difference Between the Analyses of the Above Characteristics by BC Subtype	Up to 4 weeks

Trial Locations

Locations (1)

Salvetti & Llombart Sl; 🇪🇸 Barcelona, Catalonia, Spain