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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315365
• Other study ID #: A5481055
• Status: Completed
• First received: December 4, 2014
• Last updated: March 29, 2018
• Start date: March 2015
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: PeriPharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Canada	CISSS de la Montérégie-Centre (Hôpital Charles Lemoyne)	Greenfield Park	Quebec
Canada	Kingston General Hospital	Kingston	Ontario
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

Sponsors (2)

Lead Sponsor	Collaborator
PeriPharm	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6-month follow-up after recruitment