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Health Status of Women With Breast Cancer

An Observational Study Assessing the Health Status in Women With Early Breast Cancer, Treated With Breast Conserving Surgery and Radiotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03761940
Acronym
OSTaRa
Enrollment
200
Registered
2018-12-03
Start date
2019-03-14
Completion date
2019-11-30
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Conserving Surgery, Radiotherapy, Women With Early Breast Cancer

Brief summary

The quality-adjusted life-year (QALY) is the outcome measure of choice in England and Wales for National Institute for Health and Care Excellence (NICE). To be able to conduct a cost utility analysis, QALY data is required. This can either be collected within trial or published data can be used. In the United Kingdom (UK) there is no up to date QALY data for women with early breast cancer treated with surgery followed by radiotherapy. The OSTaRa Study aims to provide up to date QALY data for women in this cohort.

Interventions

OTHEREQ5D questionnaire and a demographic questionnaire

questionnaires

Sponsors

University College, London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

* Female * Over 18 year of age * Has had breast cancer, treated with both breast conserving surgery and radiotherapy. * Is willing to complete an EQ5D and a demographic questionnaire.

Exclusion criteria

* Does not speak sufficiently to complete a study questionnaires. * Has not already been approached to complete an OSTaRa questionnaire.

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire12 monthsEach subject will complete an EQ5D questionnaire, to allow Quality of Life to be calculated. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none, slight, moderate, severe or unable to perform. Levels are coded 1-5 and a total score is then generated. Results for the demographic measured will be displayed as a percentage value.

Countries

United Kingdom

Contacts

Primary ContactChris Brew-Graves, MSc
c.brew-graves@ucl.ac.uk02076799280
Backup ContactSITU
situ.ostara@ucl.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026