BRAVE: QOL of Women With HR-Positive Metastatic BC Treated in the First-line Setting: Comparison Between Public and Private Institutions.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hospital Beneficência Portuguesa de SP - BP1 Patients from private institutions. |
Other: Quality of Life
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. |
Other: Quality of Life
Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires
|
Outcome Measures
Primary Outcome Measures
- Assess the quality of life [Baseline]
Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)
- Assess the quality of life in breast cancer [Baseline]
Assess the quality of life using the EORTC-QLQ-BR 23 (EORTC Quality of Life Questionnaire - Breast Cancer).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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Female patients ≥ 18 years of age;
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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).
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First-line treatment can be considered as cytotoxic chemotherapy, isolated endocrine therapy or endocrine therapy in combination with 4/6 cyclin inhibitors.
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Patients on treatment for at least three (3) months and no more than eighteen (18) months.
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Have performance status Eastern Cooperative Oncology Group (ECOG scale) of 0-2.
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Do not present other concomitant neoplasms.
Exclusion Criteria:
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Patients who refuse to participate.
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Illiterate patients, with low levels of education or cognitive deficits that make it difficult to answer the questions of the data collection instrument.
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Patients with life expectancy <3 months.
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Treatment with any product under investigation during the last 28 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Pérola Byington | São Paulo | Brazil |
Sponsors and Collaborators
- Beneficência Portuguesa de São Paulo
Investigators
- Principal Investigator: Débora G Jardim, MD, Beneficência Portuguesa de São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRAVE