Health Status of Women With Breast Cancer

Radiotherapy Clinical Trial

— OSTaRa  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03761940
• Other study ID #: 18/0059
• Status: Recruiting
• Start date: March 14, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: May 2019
• Source: University College, London
• Contact: Chris Brew-Graves, MSc
• Phone: 02076799280
• Email: c.brew-graves[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Conserving Surgery
• Breast Neoplasms
• Radiotherapy
• Women With Early Breast Cancer

Intervention

Other:
• EQ5D questionnaire and a demographic questionnaire
questionnaires

Locations

Country	Name	City	State
United Kingdom	Great Western Hospitals NHS Foundation Trust	Swindon	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	Each 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.	12 months