Health Status of Women With Breast Cancer

• Conditions: Breast Conserving Surgery; Radiotherapy; Women With Early Breast Cancer
• Interventions: Other: EQ5D questionnaire and a demographic questionnaire

• Registration Number: NCT03761940
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Study Start: 2019-03-14
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Distant disease	EQ5D questionnaire and a demographic questionnaire	Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with distant disease and may be undergoing treatment for this.
Disease free	EQ5D questionnaire and a demographic questionnaire	Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires are disease free.
Local recurrences	EQ5D questionnaire and a demographic questionnaire	Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with local recurrence and may be undergoing treatment for this.
Mastectomy	EQ5D questionnaire and a demographic questionnaire	Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have undergone a mastectomy.

Primary Outcome Measures

Name	Time	Method
Questionnaire	12 months	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.

Trial Locations

Locations (1)

Great Western Hospitals NHS Foundation Trust; 🇬🇧 Swindon, Wiltshire, United Kingdom