Clinical trial NCT05287139: QOL of Women With HR-Positive Metastatic BC Treated in the First-line Setting: Comparison Between Public and Private Institutions.
Official title: Quality of Life of Women With Hormone Receptor-Positive Metastatic Breast Cancer Treated in the First-line Setting: Comparison Between Public and Private Institutions.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Breast Neoplasm Female
Lead sponsor: Beneficência Portuguesa de São Paulo
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at the oncology outpatient clinic of Hospital Beneficência Portuguesa in São Paulo and Hospital Perola Byington

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess the quality of life
timeFrame: Baseline
measure: Assess the quality of life in breast cancer
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Pérola Byington
Study officials:
affiliation: Beneficência Portuguesa de São Paulo
name: Débora G Jardim, MD
role: PRINCIPAL_INVESTIGATOR
References: