Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- localized disease or locally advanced disease
- description
- Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy
- label
- metastatic disease
- description
- Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery
- label
- follow up disease
- description
- Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery
Primary outcomes (1)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSprangers 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. PMID 8874337
- BACKGROUNDBjelic-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. PMID 31959345