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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01209091
First received: August 30, 2010
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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.


Condition
Solid Tumours

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

A hundred members of the general public will be recruited in the Netherlands and in Sweden to participate in time trade off (TTO) interviews. In Sweden in order to try to match the socio-demographic profile of women suffering from HER2+ MBC, recruitment will be aimed at females aged over 50. In the Netherlands participants will be from both genders, and of mixed age, ethnicity, education and employment status categories. In Sweden, interviews will be conducted in Stockholm, Tyresö and Malmo. In the Netherlands, interviews will be conducted in Rotterdam, Amsterdam and Colmschate.

Criteria

Inclusion Criteria:

  • Age > 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209091

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01209091     History of Changes
Other Study ID Numbers: 113547, n/a/
Study First Received: August 30, 2010
Last Updated: September 23, 2010
Health Authority: Sweden: Läkemedelsverket

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014