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Update of Psychometric Properties Quality of Life of Patients With Breast Cancer (EORTCQLQBR45)

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ClinicalTrials.gov Identifier: NCT04018235
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Medical University of Graz
Université Catholique de Louvain
Hospital de Câncer de Barretos
University Hospital Rijeka
Evangelische Kliniken Gelsenkirchen, Germany
University Medical Center Freiburg
University Hospital Regensburg
Sheba Medical Center
Instituto Nazionale Tumori Fondazione Pascale
Istituto Oncologico Veneto IRCCS
Oslo University Hospital
Jagiellonian University
Oncology Department Hospital of Navarre
University of Leeds
The Netherlands Cancer Institute
Tumor- und Brust­zentrum ZeTuP St. Gallen
National Taiwan University
Information provided by (Responsible Party):
Helios University Hospital Wuppertal

Brief 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.


Condition or disease
Breast Cancer Quality of Life

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Study Type : Observational
Estimated Enrollment : 490 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official 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)
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018235


Contacts
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Contact: Vesna Bjelic-Radisic +49 202 896-1411 Vesna.Bjelic-Radisic@helios-gesundheit.de
Contact: Sina Schafer +49 202 896-1475 Sina-Maria.Schafer@helios-gesundheit.de

Locations
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Germany
Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke Recruiting
Wuppertal, Germany, 42283
Contact: Vesna Bjelic-Radisic    +49 202 896-1411    Vesna.Bjelic-Radisic@helios-gesundheit.de   
Contact: Sina Schafer    +49 202 896-1475    Sina-Maria.Schafer@helios-gesundheit.de   
Sponsors and Collaborators
Helios University Hospital Wuppertal
Medical University of Graz
Université Catholique de Louvain
Hospital de Câncer de Barretos
University Hospital Rijeka
Evangelische Kliniken Gelsenkirchen, Germany
University Medical Center Freiburg
University Hospital Regensburg
Sheba Medical Center
Instituto Nazionale Tumori Fondazione Pascale
Istituto Oncologico Veneto IRCCS
Oslo University Hospital
Jagiellonian University
Oncology Department Hospital of Navarre
University of Leeds
The Netherlands Cancer Institute
Tumor- und Brust­zentrum ZeTuP St. Gallen
National Taiwan University
Investigators
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Principal Investigator: Vesna Bjelic-Radisic Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke

Publications:
Bjelic-Radisic, V. (2018, October). An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients (EORTC QLQ-BC23)- EORTC QLQ-BR45. Presentation at the European Society for Medical Oncology [ESMO] Congress, Munich, Germany.

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Responsible Party: Helios University Hospital Wuppertal
ClinicalTrials.gov Identifier: NCT04018235     History of Changes
Other Study ID Numbers: EORTC QLQ BR45
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases