European Organisation of Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) Breast Cancer Module Update
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|ClinicalTrials.gov Identifier: NCT02979678|
Recruitment Status : Unknown
Verified September 2017 by Medical University of Graz.
Recruitment status was: Recruiting
First Posted : December 1, 2016
Last Update Posted : September 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life||Other: Questionnaire||Not Applicable|
- Based on a systematic literature search a new issue list will be developed, containing additional issues relevant for new treatment strategies. A total of 5-10 patients from different countries (5-8) as well as health care professionals (5/country) will be interviewed (Phase 1).
- Operationalization of the issues into items; a provisional version of a the questionnaire and a hypothetic scale structure will be established (Phase2).
- The resulting provisional updated module will be tested with respect to understanding, comprehensiveness and applicability (according to the EORTC Module Development Guidelines). The items will be translated from English into other languages following a standardized forward-backward procedure. Total aof 260 patients will be interviewed from different cultural areas: Northern Europe, Central Europe, Southern Europe, Asia (Phase 3).
- The module and its scale structure will be field-tested in a large, international group of patients in order to determine its acceptability, reliability, validity, responsiveness and crosscultural applicability .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||June 2019|
The questionnaire should be updated with respect to wording, terminology.
Other Name: EORTC QLQ-Breast Cancer Module Update
- Quality of life [ Time Frame: 3 years, Patients under treatment are asked once to complete the questionnaire during 3 years ]Patients under Treatment are asked to complete the questionnaire
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): NCT02979678
|Contact: Vesna Bjelic-Radisic||+43 316 385 firstname.lastname@example.org|
|Contact: Brigitte Bliem||+43 316 385 email@example.com|
|Medical University Graz||Recruiting|
|Contact: Vesna Bjelic-Radisic, MD +43 316 385 80504 firstname.lastname@example.org|
|University Hospital Centre Rijeka||Recruiting|
|Institut de Cancerologie de Lorraine||Recruiting|
|University Medical Center Regensburg||Recruiting|
|Instituto Nazionale Tumori Fondazione Pascale||Recruiting|
|IOV Oncologico Veneto Padova||Recruiting|
|Netherlands Cancer Institute - NKI||Recruiting|
|Jagiellonian University Medical College Krakow||Recruiting|
|Oncology Department Hospital of Navarre||Recruiting|
|Principal Investigator:||Vesna Bjelic-Radisic||Medical University of Graz|