Women With Early Breast CancerOSTaRaNCT03761940
Health Status of Women With Breast Cancer
An observational study of Women With Early Breast Cancer and Breast Conserving Surgery, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Women With Early Breast Cancer, Breast Conserving Surgery, Radiotherapy
- What is being tested?
- EQ5D questionnaire and a demographic questionnaire
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2019to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Participants who satisfy the inclusion exclusion criteria can be selected either from clinic notes, MDT records, or at clinic.
Who may be able to join
- 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.
Who cannot join
- Does not speak sufficiently to complete a study questionnaires.
- Has not already been approached to complete an OSTaRa questionnaire.
Trial locations and contacts
1 site in 1 country.
SITU contact
United Kingdom1 site, 1 recruiting
- Recruiting
Great Western Hospitals NHS Foundation Trust
Swindon, Wiltshire, SN3 6BB
Nathan Coombs
About this study
Official title: An Observational Study Assessing the Health Status in Women With Early Breast Cancer, Treated With Breast Conserving Surgery and Radiotherapy
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.
- Being tested
- EQ5D questionnaire and a demographic questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ5D questionnaire and a demographic questionnaireOther
questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EQ5D questionnaire and a demographic questionnaire | |
| 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. Receives: Other: EQ5D questionnaire and a demographic questionnaire | |
| 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. Receives: Other: EQ5D questionnaire and a demographic questionnaire | |
| 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. Receives: Other: EQ5D questionnaire and a demographic questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start14 Mar 2019
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Early Breast CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761940
- Sponsor's protocol ID
- 18/0059
- Acronym
- OSTaRa
- Status last verified
- May 2019
- First submitted
- 26 Oct 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The OSTaRa study team will adhere to SITU's data sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Assessing the Health Status in Women With Early Breast Cancer, Treated With Breast Conserving Surgery and Radiotherapy
- ClinicalTrials.gov ID
- NCT03761940
- Acronym / sponsor ID
- OSTaRa / 18/0059
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Disease free | – | Other: EQ5D questionnaire and a demographic questionnaireWomen 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 | – | Other: EQ5D questionnaire and a demographic questionnaireWomen 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. |
| Distant disease | – | Other: EQ5D questionnaire and a demographic questionnaireWomen 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. |
| Mastectomy | – | Other: EQ5D questionnaire and a demographic questionnaireWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Participants who satisfy the inclusion exclusion criteria can be selected either from clinic notes, MDT records, or at clinic.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Does not speak sufficiently to complete a study questionnaires.
- Has not already been approached to complete an OSTaRa questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQ5D questionnaire and a demographic questionnairequestionnaires | Other | Disease free, Distant disease, Local recurrences, Mastectomy |
Primary outcome
Questionnaire
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: Yes. The OSTaRa study team will adhere to SITU's data sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SITU contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women With Early Breast Cancer and Breast Conserving Surgery, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Brew-Graves, MSc (02076799280, c.brew-graves@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.