Clinical trial NCT04018235: Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Quality of Life
Lead sponsor: Helios University Hospital Wuppertal
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
name: Université Catholique de Louvain
name: Hospital de Câncer de Barretos
name: University Hospital Rijeka
name: Evangelische Kliniken Gelsenkirchen
name: University Medical Center Freiburg
name: University Hospital Regensburg
name: Sheba Medical Center
name: Instituto Nazionale Tumori Fondazione Pascale
name: Istituto Oncologico Veneto IRCCS
name: Oslo University Hospital
name: Jagiellonian University
name: Oncology Department Hospital of Navarre
name: University of Leeds
name: The Netherlands Cancer Institute
name: Tumor- und Brust-zentrum ZeTuP St. Gallen
name: National Taiwan University
name: Taipei Veterans General Hospital, Taiwan
name: National Center for Global Health and Medicine, Japan
name: King Hussein Cancer Center
name: Maria Sklodowska-Curie National Research Institute of Oncology
name: Kansai Medical University
name: Tikur Anbessa Hospital
name: Tata Memorial Hospital
name: Mekelle University
First posted: 2019-07-12
Enrollment: 576
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample will be composed of a series of consecutive cancer patients who meet the study eligibility criteria in each participating centre

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Psychometric Properties of the EORTC QLQ-BR45
timeFrame: baseline and for some patients 1-2 weeks later (test-retest) or 3 month later (responsiveness-to-change)
Secondary outcomes:
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke
Study officials:
affiliation: Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke
name: Vesna Bjelic-Radisic
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1200/JCO.1996.14.10.2756.
citation: 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.