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

NCT06683482 | Completed

• 1 other identifier: GS-ES-984-6674
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Responses to the Open-ended questionnaires

  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.

  Up to 4 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

Participants with Advanced Breast Cancer Living in Spain and their Caregivers

Participants with different types of breast cancers living in Spain will be observed in this study. Participants will not receive any study drug in this study.

Other: No intervention

Interventions

No intervention OTHER

No study drug will be administered as a part of this study.

Participants with Advanced Breast Cancer Living in Spain and their Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes individuals with BC subtypes in the advanced setting (TNBC, HR+/HER2-, and HER2+ \[with any HR\]), and also their caregivers will be observed in this study.

You may qualify if:

• Informed consent to individual in the qualitative study and to allow the recording of the interview for analyses purposes (individual and/or caregiver).
• Women or men (individual and/or caregiver) over 18 years of age.
• 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).
• Individuals must have initiated at least the firstline treatment.
• Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2 (individual).
• Ability to conduct interviews from home (individual and/or caregiver) or remotely (ie, with technology available for an online interview).

You may not qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Salvetti & Llombart Sl

Barcelona, Catalonia, 08008, Spain

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: February 21, 2025
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)