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

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ClinicalTrials.gov Identifier: NCT02315365
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
PeriPharm

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.


Condition or disease
Metastatic Breast Cancer

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Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post-menopausal women with ER+/HER2- locally advanced or metastatic breast cancer.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315365


Locations
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Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
CISSS de la Montérégie-Centre (Hôpital Charles Lemoyne)
Greenfield Park, Quebec, Canada, J4V 2H1
CSSS Alphonse-Desjardins
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
Sponsors and Collaborators
PeriPharm
Pfizer
Investigators
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Principal Investigator: Jean Lachaine, PhD PeriPharm

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Responsible Party: PeriPharm
ClinicalTrials.gov Identifier: NCT02315365     History of Changes
Other Study ID Numbers: A5481055
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases