An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45.

Breast Neoplasms / drug therapy Clinical Trials as Topic Humans Psychometrics Quality of Life Reproducibility of Results Surveys and Questionnaires
breast cancer module development patient-reported outcome (PRO) quality of life

Journal

Annals of oncology : official journal of the European Society for Medical Oncology
ISSN: 1569-8041
Titre abrégé: Ann Oncol
Pays: England
ID NLM: 9007735

Informations de publication

Date de publication:
02 2020
Historique:
received: 18 07 2019
revised: 25 10 2019
accepted: 28 10 2019
entrez: 22 1 2020
pubmed: 22 1 2020
medline: 7 1 2021
Statut: ppublish

Résumé

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire. The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items. The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale. Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.

Sections du résumé

BACKGROUND
The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire.
PATIENTS AND METHODS
The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items.
RESULTS
The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale.
CONCLUSION
Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.

Identifiants

DOI: 10.1016/j.annonc.2019.10.027 PMID: 31959345
pubmed: 31959345
pii: S0923-7534(19)36084-3
doi: 10.1016/j.annonc.2019.10.027
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

283-288

Investigateurs

Eveline Bleiker (E)
Brigitte Bliem (B)
Weichu Chie (W)
Carien Creutzberg (C)
Valerie Deville (V)
Francois Duhoux (F)
Kirsten Eilf (K)
Sue Hartup (S)
Michael Koller (M)
Eva Nagele (E)
Ourania Nicolatou-Galitis (O)
Anne Oberguggenberger (A)
Claudia Schmalz (C)
Zoe Winters (Z)

Commentaires et corrections

Type : ErratumIn

Informations de copyright

Copyright © 2019 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

Auteurs

V Bjelic-Radisic (V)

Breast Unit, Helios University Clinic, University Witten/Herdecke, Wuppertal, Germany. Electronic address: vesna.bjelic-radisic@helios-gesundheit.de.

F Cardoso (F)

Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.

D Cameron (D)

Cancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UK.

E Brain (E)

Department of Medical Oncology Institute Curie - Hôpital René Huguenin, Saint-Cloud, France.

K Kuljanic (K)

Department of Obstetrics and Gynecology, Clinical Center Rijeka, Rijeka, Croatia.

R A da Costa (RA)

Department of Mastology and Breast Reconstruction, Barretos Cancer Hospital, Barretos, Brazil.

T Conroy (T)

Department of Medical Oncology, Lorraine Cancer Institute, Vandoeuvre-lès-Nancy, France.

E C Inwald (EC)

Department of Gynecology and Obstetrics, University Medical Center Regensburg, Regensburg, Germany.

S Serpentini (S)

Unit for Psychooncology, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.

M Pinto (M)

National Tumor Institute, Instituto Nazionale Tumori Fondazione Pascale Naples, Naples, Italy.

J Weis (J)

Comprehensive Cancer Center, Medical Faculty, University Medical Center Freiburg, Freiburg, Germany.

O Morag (O)

Unit Pain Clinic, Sheba - Tel Ha Shomer Hospital, Tel Aviv, Israel.

G Lindviksmoen Astrup (G)

Department of Oncology, Oslo University Hospital, Oslo, Norway.

K A Tomaszweksi (KA)

Department of Surgery, Jagillonian University Medical College Krakow, Krakow, Poland.

K Pogoda (K)

Department of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.

P Sinai (P)

Southmead Hospital, University of Bristol, Bristol, UK.

M Sprangers (M)

Department of Medical Psychology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

N Aaronson (N)

Department of Psychosocial Research, NKI Netherlands, Amsterdam, The Netherlands.

G Velikova (G)

Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK.

E Greimel (E)

Department of Gynecology and Obstetrics, Medical University Graz, Graz, Austria.

J Arraras (J)

Oncology Department, Hospital of Navarre, Pamplona, Spain.

A Bottomley (A)

EORTC HQ, Quality of Life Department, Brussels, Belgium.

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Classifications MeSH

questionsmedicales.fr › Maladies de la peau et du tissu conjonctif › Maladies de la peau › Maladies du sein › Tumeurs du sein › An international update of the EORTC...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › An international update of the EORTC...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › An international update of the EORTC...
questionsmedicales.fr › Disciplines et activités comportementales › Tests psychologiques › Psychométrie › An international update of the EORTC...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › An international update of the EORTC...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Reproductibilité des résultats › An international update of the EORTC...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › An international update of the EORTC...