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Completed

NCT Number: NCT04018235

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke

Wuppertal, 42283, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Psychometric Properties of the EORTC QLQ-BR45

    Time frame: baseline and for some patients 1-2 weeks later (test-retest) or 3 month later (responsiveness-to-change)

    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)

Sponsors and collaborators

Lead sponsor

Helios University Hospital Wuppertal

Other

Collaborators

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

Registry information

Official study 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)

Acronym: EORTCQLQBR45

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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