Health Status of Women with Breast Cancer
Research type
Research Study
Full title
A cross-sectional Observational study assessing the Health Status in Women with Early Breast Cancer, Treated with Breast Conserving Surgery and Radiotherapy (OSTaRa).
IRAS ID
222801
Contact name
Jayant Vaidya
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Data Protection Registration No, Z6364106/2018/05/19 cancer research
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
For the National Institute of Health and Care Excellence (NICE) to be able to provide guidance as to whether new treatments can be used in the National Health Service, they need information on whether the treatment works and whether it is good value for money.
Clinical trials answer the question, does the treatment work, but to work out whether it is good value for money economist need to carry out an economic analysis. These analysis involve looking at costs (money and risks) and benefits (improved quality and quantity of life). NICE recommends the use of a simple, standard questionnaire called the EQ5D, to calculate the combination of quality and quantity of life. For women with early breast cancer, who have been treated with breast conserving surgery and radiotherapy there is no up to date EQ5D data in published journals for the use of developing guidelines for NICE and other reviews.
The OSTaRa Study is designed to approach a minimum of 200 women in a 12 month period to collect completed EQ5D questionnaires, calculate the utility scores (the combination of quality & quantity of life) for this group of women in the United Kingdom and make this data publically available, for economists and other researcher to use.REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1764
Date of REC Opinion
3 Dec 2018
REC opinion
Further Information Favourable Opinion