Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden

Solid Tumours Clinical Trial

Official title:

Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209091
• Other study ID #: 113547
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: February 1, 2016
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: February 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Läkemedelsverket
• Study type: Observational

Clinical Trial Summary

Introduction: Many reimbursement authorities use economic evaluation to help guide decisions regarding the adoption of new treatments in reimbursement systems. Survival and quality of life are often the main measure of benefit used in an economic evaluation - expressed as a quality adjusted life year (QALY). In addition though, some decision makers will also consider the impact of a treatment on a patient's ability to continue working (expressed in terms of productivity). The aim of the present study is to estimate quality of life weights (utilities) and productivity loss for women with metastatic breast cancer (Human Epidermal Growth Factor Receptor 2 positive or HER 2+).

Methods: Separate surveys will be used to assess utilities and productivity in HER2+ metastatic breast cancer (MBC). To capture utilities health state descriptions or vignettes describing progressive disease, stable disease, and seven grade 3/4 adverse events (diarrhoea, fatigue, anaemia, leukopenia, anorexia, decreases in left ventricular ejection fraction (LVEF), and skin rash) will be developed. The vignettes will be developed based on a literature review and in depth interviews with women with MBC in the Netherlands and Sweden. Clinical experts in both countries will review the health states for content validity. The health states will be translated using forward and back translation. Members of the general public will rate the states (100 men and women in NL; 100 women aged 50+ in Sweden) using the visual analogue scale and Time Trade Off method to determine utility values. In a separate survey women who are currently being treated or have recently completed their treatment for MBC will be surveyed regarding the impact of disease on their ability to work using a validated work productivity measure (Work Productivity and Activity Impairment) in women in the Netherlands and Sweden.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age > 18

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Solid Tumours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health utility: is a measure of strength of preference that people have for particular health states. A year in full health is arbitrarily assigned a value of 1: a state that is considered equivalent to death is assigned a value of zero			No
Secondary	Productivity loss: productive working time lost due to health related inability to work. These include the costs of lost work due to absenteeism or early retirement, impaired productivity at work, and lost or impaired leisure activity.			No