Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer

PeriPharm202 enrolled

Overview

This real-life Health Economics and Outcome Research (HEOR) study will enable to assess the impact of current therapies on quality of life (QoL), productivity loss and health care resource utilization in metastatic breast cancer (mBC). This prospective study will estimate patient-reported outcomes (PROs) and resource utilization data for mBC patients stratified according to treatment type, treatment line and disease status (progression vs. progression free) in a real-life setting. To estimate QoL, work productivity and health care resource utilization of post-menopausal patients with ER+/HER2- locally advanced or metastatic breast cancer in a real-life setting. The secondary objective is to estimate QoL and work productivity of mBC patients' caregivers. During the course of the study, data will be collected on quality of life and work productivity. Patients and caregivers will be asked to fill a set of questionnaires at their recruitment in the study, at 3 months and at 6 months after recruitment.

Study Type

OBSERVATIONAL

Enrollment

202

Conditions

Metastatic Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of locally advanced or metastatic breast cancer * Post-menopausal women * ER+/HER2- mBC * Signature of informed consent form * Ability to read and understand English or French Exclusion Criteria: * Participation to a clinical trial

Locations (5)

Kingston General Hospital

Kingston, Ontario, Canada

CISSS de la Montérégie-Centre (Hôpital Charles Lemoyne)

Greenfield Park, Quebec, Canada

CSSS Alphonse-Desjardins

Lévis, Quebec, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)

Montreal, Quebec, Canada

CHU de Québec (Hôpital du Saint-Sacrement)

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Pharmacoeconomic impact of current therapies for the treatment of mBC in a real-life setting.

Pharmacoeconomic impact will be evaluated by questionnaires completed by the patient and the caregiver. These include quality of life, health care resource utilization, work productivity and activity impairment, and health questionnaires. Data will be summarized by time points (recruitment, 3 months and 6 months) and categorized by the line of treatment (first line, second and subsequent line), by disease status (progression and progression free), by treatment type (chemotherapy and endocrine therapy, and if sample size permits by type of endocrine therapy such as anti-estrogen and aromatase inhibitors), and by specific treatment (such as letrozole and anastrozole), if sample size permits.

Time frame: 6-month follow-up after recruitment