Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer (EORTCQLQBR45)

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)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 576

Contacts and Locations

Study Locations

• Germany
  • Wuppertal, Germany, 42283
    • Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
localized disease or locally advanced disease; Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy
metastatic disease; Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery
follow up disease; Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Helios University Hospital Wuppertal
• Collaborators: Medical University of Graz; Oslo University Hospital; Jagiellonian University; University of Leeds; Taipei Veterans General Hospital, Taiwan; Sheba Medical Center; Université Catholique de Louvain; Istituto Oncologico Veneto IRCCS; The Netherlands Cancer Institute; University Hospital Rijeka; Tata Memorial Hospital; National Center for Global Health and Medicine, Japan; University Hospital Regensburg; National Taiwan University; King Hussein Cancer Center; Maria Sklodowska-Curie National Research Institute of Oncology; Hospital de Câncer de Barretos; Mekelle University; University Medical Center Freiburg; Kansai Medical University; Evangelische Kliniken Gelsenkirchen; Instituto Nazionale Tumori Fondazione Pascale; Oncology Department Hospital of Navarre; Tumor- und Brust-zentrum ZeTuP St. Gallen; Tikur Anbessa Hospital
• Investigators: Principal Investigator: Vesna Bjelic-Radisic, Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2019
• Primary Completion (ACTUAL): December 17, 2021
• Study Completion (ACTUAL): December 17, 2021

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: EORTC QLQ BR45

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