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

Breast Cancer Clinical Trial

— EORTCQLQBR45  

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- EORTCQLQ BR45)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018235
• Other study ID #: EORTC QLQ BR45
• Status: Completed
• Start date: June 14, 2019
• Est. completion date: December 17, 2021

Study information

• Verified date: July 2022
• Source: Helios University Hospital Wuppertal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed diagnosis of breast cancer

• no previous primary or recurrent tumour

• ability to understand the language of the questionnaire

• mental fitness to complete a questionnaire

• 18 years of age or above

• written informed consent.

Exclusion Criteria:

• no histologically confirmed diagnosis of breast cancer

• previous primary or recurrent tumour

• not mentally fit to complete a questionnaire

• not able to understand the language of the questionnaire

• younger than 18

• refusal of informed consent

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life

Locations

Country	Name	City	State
Germany	Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke	Wuppertal

Sponsors (26)

Lead Sponsor

Collaborator

Helios University Hospital Wuppertal

Evangelische Kliniken Gelsenkirchen, Hospital de Câncer de Barretos, Instituto Nazionale Tumori Fondazione Pascale, Istituto Oncologico Veneto IRCCS, Jagiellonian University, Kansai Medical University, King Hussein Cancer Center, Maria Sklodowska-Curie National Research Institute of Oncology, Medical University of Graz, Mekelle University, National Center for Global Health and Medicine, Japan, National Taiwan University, Oncology Department Hospital of Navarre, Oslo University Hospital, Sheba Medical Center, Taipei Veterans General Hospital, Taiwan, Tata Memorial Hospital, The Netherlands Cancer Institute, Tikur Anbessa Hospital, Tumor- und Brust-zentrum ZeTuP St. Gallen, Université Catholique de Louvain, University Hospital Regensburg, University Hospital Rijeka, University Medical Center Freiburg, University of Leeds

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Bjelic-Radisic V, Cardoso F, Cameron D, Brain E, Kuljanic K, da Costa RA, Conroy T, Inwald EC, Serpentini S, Pinto M, Weis J, Morag O, Lindviksmoen Astrup G, Tomaszweksi KA, Pogoda K, Sinai P, Sprangers M, Aaronson N, Velikova G, Greimel E, Arraras J, Bottomley A; EORTC Quality of Life Group and Breast Cancer Group. An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45. Ann Oncol. 2020 Feb;31(2):283-288. doi: 10.1016/j.annonc.2019.10.027. Epub 2019 Dec 18. Erratum in: Ann Oncol. 2020 Apr;31(4):552. — View Citation

Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric Properties of the EORTC QLQ-BR45	Psychometric Properties of the EORTC QLQ-BR45 (scale structure, reliability, internal consistency, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer)	baseline and for some patients 1-2 weeks later (test-retest) or 3 month later (responsiveness-to-change)