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

NCT05287139 | Unknown

• 1 other identifier: BRAVE
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Breast Neoplasm Female

Outcome Measures

Primary Outcomes (2)

• Assess the quality of life

  Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)

  Baseline

• Assess the quality of life in breast cancer

  Assess the quality of life using the EORTC-QLQ-BR 23 (EORTC Quality of Life Questionnaire - Breast Cancer).

  Baseline

Study Arms (2)

Hospital Beneficência Portuguesa de SP - BP1

Patients from private institutions.

Other: Quality of Life

Hospital Pérola Byington - HPB2

Patients from public institutions.

Other: Quality of Life

Interventions

Quality of Life OTHER

Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires

Hospital Beneficência Portuguesa de SP - BP1; Hospital Pérola Byington - HPB2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo: lead

Study Sites (1)

Hospital Pérola Byington

São Paulo, Brazil

Location

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Débora G Jardim, MD

  Beneficência Portuguesa de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: July 14, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

BR (1)