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

NCT02315365 | Completed

• 1 other identifier: A5481055
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Participation to a clinical trial

Sponsors & Collaborators

• PeriPharm: lead
• Pfizer: collaborator

Study Sites (5)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

CISSS de la Montérégie-Centre (Hôpital Charles Lemoyne)

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CSSS Alphonse-Desjardins

Lévis, Quebec, G6V 3Z1, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

CHU de Québec (Hôpital du Saint-Sacrement)

Québec, Quebec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean Lachaine, PhD

  PeriPharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 11, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

CA (5)