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

March 29, 2018 updated by: PeriPharm

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Montérégie-Centre (Hôpital Charles Lemoyne)
      • Lévis, Quebec, Canada, G6V 3Z1
        • CSSS Alphonse-Desjardins
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
      • Québec, Quebec, Canada, G1S 4L8
        • CHU de Québec (Hôpital du Saint-Sacrement)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Post-menopausal women with ER+/HER2- locally advanced or metastatic breast cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-month follow-up after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeriPharm

Collaborators

Pfizer

Investigators

  • Principal Investigator: Jean Lachaine, PhD, PeriPharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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