European Organisation of Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) Breast Cancer Module Update

Not Applicable

• Conditions: Quality of Life
• Interventions: Other: Questionnaire

• Registration Number: NCT02979678
• Lead Sponsor: Medical University of Graz

Brief Summary

The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the development of BR-23 published 1996 the standard therapy of breast cancer has changed. New therapies brought new side effects and different impact on QoL (quality of life) are not sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both from clinical and scientific point of view.

Detailed Description

1. 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).

2. Operationalization of the issues into items; a provisional version of a the questionnaire and a hypothetic scale structure will be established (Phase2).

3. 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).

4. 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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-06
• Primary Completion: 2018-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

• Patients with early or metastatic breast cancer

Exclusion Criteria

• Patients with second malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Questionnaire	Questionnaire	Breast cancer

Primary Outcome Measures

Name	Time	Method
Quality of life	3 years, Patients under treatment are asked once to complete the questionnaire during 3 years	Patients under Treatment are asked to complete the questionnaire

Trial Locations

Locations (9)

University Hospital Centre Rijeka; 🇭🇷 Rijeka, Croatia

Institut de Cancerologie de Lorraine; 🇫🇷 Lorraine, France

Instituto Nazionale Tumori Fondazione Pascale; 🇮🇹 Naples, Italy

University Medical Center Regensburg; 🇩🇪 Regensburg, Germany

IOV Oncologico Veneto Padova; 🇮🇹 Padivarma, Italy

Jagiellonian University Medical College Krakow; 🇵🇱 Krakow, Poland

Oncology Department Hospital of Navarre; 🇪🇸 Navarra, Spain

Netherlands Cancer Institute - NKI; 🇳🇱 Amsterdam, Netherlands

Medical University Graz; 🇦🇹 Graz, Austria