An EORTC Study Updating the QLQ-BR23 to BR45

An International Phase 4 Field Study to Analyse the Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer (EORTC QLQ-BR23, Update EORTC QLQ-BR45)

Female breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC Quality of life group decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies.

The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ-C30 in patients diagnosed with breast cancer. Participants will be enrolled in four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible.

According to sample size calculations, we will include a total of N =490 patients from 12 countries.

Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF).

Study Overview

• Status: Completed
• Conditions: Cancer; Breast Cancer
• Intervention / Treatment: Other: EORTC QLQ-BR45 questionnaire

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

• Study Contact: Name: Galina Velikova; Phone Number: 0113 2067917; Email: G.Velikova@leeds.ac.uk
• Study Contact Backup: Name: Sarah Dickinson; Phone Number: 01132068968; Email: s.dickinson@leeds.ac.uk

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients

Description

Inclusion Criteria:

• Adult females aged 18 years or over
• Histologically confirmed diagnosis of breast cancer (any type) with no previous primary or recurrent tumour
• Receiving or have previously received curative or palliative treatment.
• Able to understand/speak English and complete the questionaires
• Have the capacity/mental fitness to give written informed consent and complete the questionnaires.

Exclusion Criteria:

• Male gender or transgender
• Inability to understand/speak English and complete the questionnaire
• Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Group 1 consists of breast cancer patients with local or locally advanced disease. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. A subgroup of participants within this group (those who have changed disease or treatment status) will be asked to complete the above questionnaires again, three months later (+-1 week). They will also complete an anchor question. Completing twice is for the responsiveness to change analysis.	Other: EORTC QLQ-BR45 questionnaire; The EORTC QLQ-BR23 questionnaire has been updated with a further twenty-two items to create the EORTC QLQ-BR45. This updated questionnaire contains items to encapsulate advancements in knowledge about the epidemiology of breast cancer and side effects experienced with new treatments. This study will test the psychometric properties of the EORTC QLQ-BR45 as a measure of quality of life in patients with breast cancer.
Group 2; Group 2 consists of metastatic breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires at one time point only.	Other: EORTC QLQ-BR45 questionnaire; The EORTC QLQ-BR23 questionnaire has been updated with a further twenty-two items to create the EORTC QLQ-BR45. This updated questionnaire contains items to encapsulate advancements in knowledge about the epidemiology of breast cancer and side effects experienced with new treatments. This study will test the psychometric properties of the EORTC QLQ-BR45 as a measure of quality of life in patients with breast cancer.
Group 3 - follow up; Group 3 consists of follow up breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. One-to two weeks later, a subgroup of participants in this group (with no evidence of disease and /or change in health status) will complete the above questionnaires, as well as an anchor question. Completing twice is for the test-retest analysis.	Other: EORTC QLQ-BR45 questionnaire; The EORTC QLQ-BR23 questionnaire has been updated with a further twenty-two items to create the EORTC QLQ-BR45. This updated questionnaire contains items to encapsulate advancements in knowledge about the epidemiology of breast cancer and side effects experienced with new treatments. This study will test the psychometric properties of the EORTC QLQ-BR45 as a measure of quality of life in patients with breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC-BR45 questionnaire	This is a questionnaire validation study. No reporting score on scale.	2020-2021

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: The Leeds Teaching Hospitals NHS Trust; European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Principal Investigator: Galina Velikova, University of Leeds

Publications and helpful links

Helpful Links

• Webpage with brief study description

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; PRO; PROM; EORTC; Adverse Event
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 275142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No