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

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.

Conditions

• Breast Cancer
• Quality of Life

Sponsors & Collaborators

• Medical University of Graz

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• Hospital de Câncer de Barretos

  collaborator OTHER

• University Hospital Rijeka

  collaborator OTHER

• Evangelische Kliniken Gelsenkirchen

  collaborator UNKNOWN

• University Medical Center Freiburg

  collaborator OTHER

• University Hospital Regensburg

  collaborator OTHER

• Sheba Medical Center

  collaborator OTHER_GOV

• Instituto Nazionale Tumori Fondazione Pascale

  collaborator UNKNOWN

• Istituto Oncologico Veneto IRCCS

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Jagiellonian University

  collaborator OTHER

• Oncology Department Hospital of Navarre

  collaborator UNKNOWN

• University of Leeds

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• Tumor- und Brust-zentrum ZeTuP St. Gallen

  collaborator UNKNOWN

• National Taiwan University

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• National Center for Global Health and Medicine, Japan

  collaborator OTHER_GOV

• King Hussein Cancer Center

  collaborator OTHER

• Maria Sklodowska-Curie National Research Institute of Oncology

  collaborator OTHER

• Kansai Medical University

  collaborator OTHER

• Tikur Anbessa Hospital

  collaborator UNKNOWN

• Tata Memorial Hospital

  collaborator OTHER_GOV

• Mekelle University

  collaborator OTHER

• Helios University Hospital Wuppertal

  lead OTHER

Principal Investigators

• Vesna Bjelic-Radisic · Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-14

Primary Completion

2021-12-17

Completion

2021-12-17

Countries

• Germany

Study Locations