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

September 5, 2017 updated by: Medical University of Graz

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
  • Croatia
      • Rijeka, Croatia
        • Recruiting
        • University Hospital Centre Rijeka
  • France
      • Lorraine, France
        • Recruiting
        • Institut de Cancérologie de Lorraine
  • Germany
      • Regensburg, Germany
        • Recruiting
        • University Medical Center Regensburg
  • Italy
      • Naples, Italy
        • Recruiting
        • Instituto Nazionale Tumori Fondazione Pascale
      • Padivarma, Italy
        • Recruiting
        • IOV Oncologico Veneto Padova
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Netherlands Cancer Institute - NKI
  • Poland
      • Krakow, Poland
        • Recruiting
        • Jagiellonian University Medical College Krakow
  • Spain
      • Navarra, Spain
        • Recruiting
        • Oncology Department Hospital of Navarre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with early or metastatic breast cancer

Exclusion Criteria:

  • Patients with second malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Questionnaire
Breast cancer
Other: Questionnaire
The questionnaire should be updated with respect to wording, terminology.
Other Names:
  • EORTC QLQ-Breast Cancer Module Update

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years, Patients under treatment are asked once to complete the questionnaire during 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Vesna Bjelic-Radisic, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (ESTIMATE)

December 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 27-355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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