Quality of LifeBRAVENCT05287139
QOL of Women With HR-Positive Metastatic BC Treated in the First-line Setting: Comparison Between Public and Private Institutions.
An observational study of Quality of Life and Breast Neoplasm Female, run by Beneficência Portuguesa de São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Life, Breast Neoplasm Female
- What is being tested?
- Quality of Life
- How many people
- 202 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jul 2021to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at the oncology outpatient clinic of Hospital Beneficência Portuguesa in São Paulo and Hospital Perola Byington
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Quality of Life, Breast Neoplasm Female
- Being tested
- Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of LifeOther
Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Hospital Beneficência Portuguesa de SP - BP1 | Patients from private institutions. Receives: Other: Quality of Life | |
| Hospital Pérola Byington - HPB2 | Patients from public institutions. Receives: Other: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the quality of life
Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start14 Jul 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beneficência Portuguesa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debora de Melo Gagliato Jardim, Beneficência Portuguesa de São Paulo
- Investigators
- Débora G Jardim, MD, Principal investigator, Beneficência Portuguesa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287139
- Sponsor's protocol ID
- BRAVE
- Acronym
- BRAVE
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05287139
- Acronym / sponsor ID
- BRAVE / BRAVE
- Conditions
- Quality of Life, Breast Neoplasm Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Beneficência Portuguesa de São PauloUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital Beneficência Portuguesa de SP - BP1 | – | Other: Quality of LifePatients from private institutions. |
| Hospital Pérola Byington - HPB2 | – | Other: Quality of LifePatients from public institutions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the oncology outpatient clinic of Hospital Beneficência Portuguesa in São Paulo and Hospital Perola Byington
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of LifeAssessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires | Other | Hospital Beneficência Portuguesa de SP - BP1, Hospital Pérola Byington - HPB2 |
Primary outcome
Assess the quality of life
Time frame: Baseline
Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Débora G Jardim, MD principal investigator
Beneficência Portuguesa de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Breast Neoplasm Female, run by Beneficência Portuguesa de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the quality of life (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.