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NCT Number: NCT06683482

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Salvetti & Llombart Sl

Barcelona, Catalonia, 08008, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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).

Key Exclusion Criteria:

  • 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Number of Participants With Responses to the Open-ended questionnaires

    Time frame: 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 outcomes

  1. Number of Participants with Responses to the Open-ended Questionnaires Related to Intimacy and Sexuality

    Time frame: Up to 4 weeks

  2. Number of Participants With Responses to the Economic Impact of the Disease

    Time frame: Up to 4 weeks

  3. Number of Participants With Responses Open-ended Interviews to Assess Importance of Hereditary BC, Genetic Testing and Generic Counselling in ABC Patients

    Time frame: Up to 4 weeks

  4. 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

    Time frame: Up to 4 weeks

  5. 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

    Time frame: Up to 4 weeks

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

Ethnographic Study on Advanced Breast Cancer Patients and Their Caregivers in Spain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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