Health Status of Women With Breast Cancer (OSTaRa)

University College London (UCL)

Status: Unknown

Conditions: Women With Early Breast Cancer; Breast Conserving Surgery; Radiotherapy

Treatments: Other: EQ5D questionnaire and a demographic questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT03761940

18/0059

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 4 patient groups

Disease free

Description:

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.

Treatment:

Other: EQ5D questionnaire and a demographic questionnaire

Local recurrences

Description:

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.

Treatment:

Other: EQ5D questionnaire and a demographic questionnaire

Distant disease

Description:

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.

Treatment:

Other: EQ5D questionnaire and a demographic questionnaire

Mastectomy

Description:

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.

Treatment:

Other: EQ5D questionnaire and a demographic questionnaire