The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3

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

Sponsors

Lead sponsor: Medical University of Graz

Source 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 .

Overall Status Unknown status
Start Date June 2015
Completion Date June 2019
Primary Completion Date March 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Quality of life 3 years, Patients under treatment are asked once to complete the questionnaire during 3 years
Enrollment 260
Condition
Intervention

Intervention type: Other

Intervention name: Questionnaire

Description: The questionnaire should be updated with respect to wording, terminology.

Arm group label: Questionnaire

Other name: EORTC QLQ-Breast Cancer Module Update

Eligibility

Criteria:

Inclusion Criteria:

- Patients with early or metastatic breast cancer

Exclusion Criteria:

- Patients with second malignancy

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Vesna Bjelic-Radisic Principal Investigator Medical University of Graz
Overall Contact

Last name: Vesna Bjelic-Radisic

Phone: +43 316 385 80504

Email: [email protected]

Location
facility status contact
Medical University Graz | Graz, Austria Recruiting Vesna Bjelic-Radisic, MD +43 316 385 80504 [email protected]
University Hospital Centre Rijeka | Rijeka, Croatia Recruiting
Institut de Cancerologie de Lorraine | Lorraine, France Recruiting
University Medical Center Regensburg | Regensburg, Germany Recruiting
Instituto Nazionale Tumori Fondazione Pascale | Naples, Italy Recruiting
IOV Oncologico Veneto Padova | Padivarma, Italy Recruiting
Netherlands Cancer Institute - NKI | Amsterdam, Netherlands Recruiting
Jagiellonian University Medical College Krakow | Krakow, Poland Recruiting
Oncology Department Hospital of Navarre | Navarra, Spain Recruiting
Location Countries

Austria

Croatia

France

Germany

Italy

Netherlands

Poland

Spain

Verification Date

September 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: Questionnaire

Arm group type: Experimental

Description: Breast cancer

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov