NCT04018235

Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer

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- EORTCQLQ BR45)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 576 (actual)
• Sponsor: Helios University Hospital Wuppertal · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Females 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 QLG 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 three groups according to their disease stage (1. localized disease or locally advanced disease, 2. metastatic disease, 3. follow up). Various combinations of therapies are permissible, resulting in a total of 17 subgroups.

Conditions

• Breast Cancer
• Quality of Life

Timeline

• Start date: 2019-06-14
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2019-07-12
• Last updated: 2022-07-20

Locations

1 site across 1 country: Germany