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

Sponsor
Medical University of Graz (Other)
Overall Status
Unknown status
CT.gov ID
NCT02979678
Collaborator
(none)
260
Enrollment
9
Locations
1
Arm
48
Duration (Months)
28.9
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
N/A
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 :
Jun 1, 2015
Anticipated Primary Completion Date :
Mar 1, 2018
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with early or metastatic breast cancer
    Exclusion Criteria:
    • Patients with second malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Graz Graz Austria
    2 University Hospital Centre Rijeka Rijeka Croatia
    3 Institut de Cancerologie de Lorraine Lorraine France
    4 University Medical Center Regensburg Regensburg Germany
    5 Instituto Nazionale Tumori Fondazione Pascale Naples Italy
    6 IOV Oncologico Veneto Padova Padivarma Italy
    7 Netherlands Cancer Institute - NKI Amsterdam Netherlands
    8 Jagiellonian University Medical College Krakow Krakow Poland
    9 Oncology Department Hospital of Navarre Navarra Spain

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT02979678
    Other Study ID Numbers:
    • 27-355
    First Posted:
    Dec 1, 2016
    Last Update Posted:
    Sep 6, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Medical University of Graz
    Breast cancer, quality of life

    Study Results

    No Results Posted as of Sep 6, 2017