QOL of Women With HR-Positive Metastatic BC Treated in the First-line Setting: Comparison Between Public and Private Institutions. (BRAVE)

Beneficência Portuguesa de São Paulo

Status

Unknown

Conditions

Breast Neoplasm Female

Quality of Life

Treatments

Other: Quality of Life

Study type

Observational

Funder types

Other

Identifiers

NCT05287139

BRAVE

Details and patient eligibility

About

Assess the quality of life in patients with hormone receptor positive, human epidermal growth factor receptor-type 2 negative metastatic breast cancer treated in first line (patients with new metastasis or recurrence during adjuvant endocrine therapy): comparison between public and private institutions. The hypothesis to be evaluated is that patients treated in private institutions have a better quality of life when compared to patients treated in public institutions.

Full description

The main objective of the study is to assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire) and the EORTC-QLQ-BR23 (EORTC Quality of Life Questionnaire - Breast Cancer) of a patient with metastatic breast cancer hormone receptor positive human epidermal growth factor receptor-type 2 negative receiving treatment in the first-line scenario, comparing public and private institutions.

Enrollment

202 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who agree to participate by signing a document of free and informed consent (ICF), indicating that the research participant was informed about all relevant aspects of the study;
Female patients ≥ 18 years of age;
Patients diagnosed with hormone receptor positive, human epidermal growth factor receptor-type 2 -negative metastatic breast cancer; in first-line treatment (metastatic de novo disease or patients with recurrence during adjuvant endocrine therapy).
First-line treatment can be considered as cytotoxic chemotherapy, isolated endocrine therapy or endocrine therapy in combination with 4/6 cyclin inhibitors.
Patients on treatment for at least three (3) months and no more than eighteen (18) months.
Have performance status Eastern Cooperative Oncology Group (ECOG scale) of 0-2.
Do not present other concomitant neoplasms.

Exclusion criteria

Patients who refuse to participate.
Illiterate patients, with low levels of education or cognitive deficits that make it difficult to answer the questions of the data collection instrument.
Patients with life expectancy <3 months.
Treatment with any product under investigation during the last 28 days.