Breast Neoplasm Female, Quality of Life
Conditions
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.
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.
Interventions
OTHERQuality of Life
Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires
Sponsors
Beneficência Portuguesa de São Paulo
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Brazil
Outcome results
None listed