An EORTC Study Updating the QLQ-BR23 to BR45

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270123
• Other study ID #: 275142
• Status: Completed
• Start date: November 2, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2023
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 31, 2022
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Leeds	European Organisation for Research and Treatment of Cancer - EORTC, The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC-BR45 questionnaire	This is a questionnaire validation study. No reporting score on scale.	2020-2021

External Links

•   Webpage with brief study description