Health Status of Women With Breast Cancer

NCT ID: NCT03761940

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-14

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Women With Early Breast Cancer Breast Conserving Surgery Radiotherapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Disease free

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.

EQ5D questionnaire and a demographic questionnaire

Intervention Type OTHER

questionnaires

Local recurrences

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.

EQ5D questionnaire and a demographic questionnaire

Intervention Type OTHER

questionnaires

Distant disease

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.

EQ5D questionnaire and a demographic questionnaire

Intervention Type OTHER

questionnaires

Mastectomy

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.

EQ5D questionnaire and a demographic questionnaire

Intervention Type OTHER

questionnaires

Interventions

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EQ5D questionnaire and a demographic questionnaire

questionnaires

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Great Western Hospitals NHS Foundation Trust

Swindon, Wiltshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Chris Brew-Graves, MSc

Role: CONTACT

02076799280

SITU

Role: CONTACT

Other Identifiers

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18/0059

Identifier Type: -

Identifier Source: org_study_id

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