JOURNAL ONKOLOGIE – STUDIE
EORTCQLQBR45 Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer
Rekrutierend
NCT-Nummer:
NCT04018235
Studienbeginn:
Juni 2019
Letztes Update:
12.12.2019
Wirkstoff:
-
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Helios University Hospital Wuppertal
Collaborator:
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, Insti
Studienleiter
Principal Investigator
Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke
Kontakt
Kontakt:
Phone: +49 202 896-1411
E-Mail: Vesna.Bjelic-Radisic@helios-gesundheit.de» Kontaktdaten anzeigen
Kontakt:
Phone: +49 202 896-1475
E-Mail: Sina-Maria.Schafer@helios-gesundheit.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke
42283 Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vesna Bjelic-Radisic
Phone: +49 202 896-1411
E-Mail: Vesna.Bjelic-Radisic@helios-gesundheit.de
Sina Schafer
Phone: +49 202 896-1475
E-Mail: Sina-Maria.Schafer@helios-gesundheit.de» Ansprechpartner anzeigen
42283 Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vesna Bjelic-Radisic
Phone: +49 202 896-1411
E-Mail: Vesna.Bjelic-Radisic@helios-gesundheit.de
Sina Schafer
Phone: +49 202 896-1475
E-Mail: Sina-Maria.Schafer@helios-gesundheit.de» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome: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)
Studien-Arme
- 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
Quelle: ClinicalTrials.gov