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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02979678

Enrollment

260

Registered

2016-12-01

Start date

2015-06-30

Completion date

2019-06-30

Last updated

2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

Breast cancer, quality of life

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 .

Interventions

OTHERQuestionnaire

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with early or metastatic breast cancer

Exclusion criteria

* Patients with second malignancy

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Austria, Croatia, France, Germany, Italy, Netherlands, Poland, Spain

Contacts

Primary ContactVesna Bjelic-Radisic

vesna.bjelic-radisic@medunigraz.at+43 316 385 80504

Backup ContactBrigitte Bliem

brigitte.bliem@medunigraz.at+43 316 385 81426

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026