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

Quality of Life Clinical Trial

— BRAVE  

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05287139
• Other study ID #: BRAVE
• Status: Enrolling by invitation
• Start date: July 14, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: March 2022
• Source: Beneficência Portuguesa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 202
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Quality of Life

Intervention

Other:
• Quality of Life
Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires

Locations

Country	Name	City	State
Brazil	Hospital Pérola Byington	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Beneficência Portuguesa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the quality of life	Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)	Baseline
Primary	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