Health Status of Women With Breast Cancer (OSTaRa)

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.

Study Overview

• Status: Unknown
• Conditions: Radiotherapy; Breast Conserving Surgery; Women With Early Breast Cancer
• Intervention / Treatment: Other: EQ5D questionnaire and a demographic questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Chris Brew-Graves, MSc; Phone Number: 02076799280; Email: c.brew-graves@ucl.ac.uk
• Study Contact Backup: Name: SITU; Email: situ.ostara@ucl.ac.uk

Study Locations

• United Kingdom
  • Wiltshire
    • Swindon, Wiltshire, United Kingdom, SN3 6BB
      • Recruiting
      • Great Western Hospitals NHS Foundation Trust
      • Principal Investigator: Nathan Coombs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: EQ5D questionnaire and a demographic questionnaire; 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.	Other: EQ5D questionnaire and a demographic questionnaire; 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.	Other: EQ5D questionnaire and a demographic questionnaire; questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2019
• Primary Completion (ANTICIPATED): November 30, 2019
• Study Completion (ANTICIPATED): November 30, 2019

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (ACTUAL): December 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 18/0059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The OSTaRa study team will adhere to SITU's data sharing policy.
• IPD Sharing Time Frame: Once the study has been published
• IPD Sharing Access Criteria: Apply to SITU requesting the study data set. Send your request to situ.trial@ucl.ac.uk
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF