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

NCT ID: NCT05287139

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-14

Study Completion Date

2022-07-30

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.

Conditions

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Quality of Life Breast Neoplasm Female

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hospital Beneficência Portuguesa de SP - BP1

Patients from private institutions.

Quality of Life

Intervention Type OTHER

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.

Quality of Life

Intervention Type OTHER

Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires

Interventions

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Quality of Life

Assessment of patients' quality of life using the EORTC QLQ-C30 and EORTC-QLQ-BR 23 questionnaires

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beneficência Portuguesa de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Debora de Melo Gagliato Jardim

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Débora G Jardim, MD

Role: PRINCIPAL_INVESTIGATOR

Beneficência Portuguesa de São Paulo

Locations

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Hospital Pérola Byington

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BRAVE

Identifier Type: -

Identifier Source: org_study_id

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