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

• Conditions: Quality of Life; Breast Neoplasm Female
• Interventions: Other: Quality of Life

• Registration Number: NCT05287139
• Lead Sponsor: Beneficência Portuguesa de São Paulo

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.

Study Timeline

• Study Start: 2021-07-14
• Status Verified: 2022-03
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 202

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospital Pérola Byington - HPB2	Quality of Life	Patients from public institutions.
Hospital Beneficência Portuguesa de SP - BP1	Quality of Life	Patients from private institutions.

Primary Outcome Measures

Name	Time	Method
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).
Assess the quality of life	Baseline	Assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire)

Trial Locations

Locations (1)

Hospital Pérola Byington; 🇧🇷 São Paulo, Brazil