Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT02315365|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 30, 2018
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.
|Condition or disease|
|Metastatic Breast Cancer|
|Study Type :||Observational|
|Actual Enrollment :||202 participants|
|Official Title:||Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
- Pharmacoeconomic impact of current therapies for the treatment of mBC in a real-life setting. [ Time Frame: 6-month follow-up after recruitment ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315365
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|CISSS de la Montérégie-Centre (Hôpital Charles Lemoyne)|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|Lévis, Quebec, Canada, G6V 3Z1|
|CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)|
|Montreal, Quebec, Canada, H1T 2M4|
|CHU de Québec (Hôpital du Saint-Sacrement)|
|Québec, Quebec, Canada, G1S 4L8|
|Principal Investigator:||Jean Lachaine, PhD||PeriPharm|