Clinical trial NCT06683482: A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
Official title: Ethnographic Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Key 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

Primary outcomes:
measure: Number of Participants With Responses to the Open-ended questionnaires
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Number of Participants with Responses to the Open-ended Questionnaires Related to Intimacy and Sexuality
timeFrame: Up to 4 weeks
measure: Number of Participants With Responses to the Economic Impact of the Disease
timeFrame: Up to 4 weeks
measure: Number of Participants With Responses Open-ended Interviews to Assess Importance of Hereditary BC, Genetic Testing and Generic Counselling in ABC Patients
timeFrame: Up to 4 weeks
measure: 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
timeFrame: Up to 4 weeks
measure: 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
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Salvetti & Llombart Sl
state: Catalonia
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: