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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quality of Life of Women With Hormone Receptor-Positive Metastatic Breast Cancer Treated in the First-line Setting: Comparison Between Public and Private Institutions.

Conditions
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Quality of Life, Breast Neoplasm Female

Intervention / Treatment
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* Other: Quality of Life


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital Beneficência Portuguesa de SP - BP1<br>Patients from private institutions. | Other: Quality of Life<br>* Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires<br>|
| Hospital Pérola Byington - HPB2<br>Patients from public institutions. | Other: Quality of Life<br>* Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |