QOL of Women With HR-Positive Metastatic BC Treated in the First-line Setting: Comparison Between Public and Private Institutions. (BRAVE)
March 10, 2022 updated by: Debora de Melo Gagliato Jardim, Beneficência Portuguesa de São Paulo
Quality of Life of Women With Hormone Receptor-Positive Metastatic Breast Cancer Treated in the First-line Setting: Comparison Between Public and Private Institutions.
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
202
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil
- Hospital Perola Byington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hospital Beneficência Portuguesa de SP - BP1
Patients from private institutions.
|
Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires
|
|
Hospital Pérola Byington - HPB2
Patients from public institutions.
|
Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the quality of life
Time Frame: Baseline
|
Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)
|
Baseline
|
|
Assess the quality of life in breast cancer
Time Frame: Baseline
|
Assess the quality of life using the EORTC-QLQ-BR 23 (EORTC Quality of Life Questionnaire - Breast Cancer).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Débora G Jardim, MD, Beneficencia Portuguesa de Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2021
Primary Completion (Anticipated)
July 30, 2022
Study Completion (Anticipated)
July 30, 2022
Study Registration Dates
First Submitted
March 10, 2022
First Submitted That Met QC Criteria
March 10, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 18, 2022
Last Update Submitted That Met QC Criteria
March 10, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRAVE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.