NCT03761940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 14, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

October 26, 2018

Last Update Submit

May 2, 2019

Conditions

Women With Early Breast CancerBreast Conserving SurgeryRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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.

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.

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.

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.

Other: EQ5D questionnaire and a demographic questionnaire

Interventions

EQ5D questionnaire and a demographic questionnaireOTHER

questionnaires

Disease freeDistant diseaseLocal recurrencesMastectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who satisfy the inclusion exclusion criteria can be selected either from clinic notes, MDT records, or at clinic.

You may qualify if:

  • 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.

You may not qualify if:

  • Does not speak sufficiently to complete a study questionnaires.
  • Has not already been approached to complete an OSTaRa questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Western Hospitals NHS Foundation Trust

Swindon, Wiltshire, SN3 6BB, United Kingdom

RECRUITING

Central Study Contacts

Chris Brew-Graves, MSc

CONTACT

02076799280c.brew-graves@ucl.ac.uk

SITU

CONTACT

situ.ostara@ucl.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

December 3, 2018

Study Start

March 14, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

The OSTaRa study team will adhere to SITU's data sharing policy.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Once the study has been published
Access Criteria
Apply to SITU requesting the study data set. Send your request to situ.trial@ucl.ac.uk
More information

Locations

GB(1)