Last updated: 11/03/2018 15:16:58

Utility and work productivity data for economic evaluation of breast cancer therapies in the Netherlands and Sweden

GSK study ID
113547
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Utility and work productivity data for economic evaluation of breast cancer therapies in the Netherlands and Sweden
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: n/a

Secondary outcomes:

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.

Timeframe: n/a

Interventions:
Not applicable
Enrollment:
200
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Solid Tumours
Product
lapatinib
Collaborators
Not applicable
Study date(s)
August 2009 to October 2009
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
  • Age > 18
  • N/A

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-01-10

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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