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Trial record 44 of 51627 for:    questionnaire

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

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ClinicalTrials.gov Identifier: NCT02979678
Recruitment Status : Unknown
Verified September 2017 by Medical University of Graz.
Recruitment status was:  Recruiting
First Posted : December 1, 2016
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Questionnaire Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
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 : June 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Questionnaire
Breast cancer
Other: Questionnaire
The questionnaire should be updated with respect to wording, terminology.
Other Name: EORTC QLQ-Breast Cancer Module Update




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with early or metastatic breast cancer

Exclusion Criteria:

  • Patients with second malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979678


Contacts
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Contact: Vesna Bjelic-Radisic +43 316 385 80504 vesna.bjelic-radisic@medunigraz.at
Contact: Brigitte Bliem +43 316 385 81426 brigitte.bliem@medunigraz.at

Locations
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Austria
Medical University Graz Recruiting
Graz, Austria
Contact: Vesna Bjelic-Radisic, MD    +43 316 385 80504    vesna.bjelic-radisic@medunigraz.at   
Croatia
University Hospital Centre Rijeka Recruiting
Rijeka, Croatia
France
Institut de Cancerologie de Lorraine Recruiting
Lorraine, France
Germany
University Medical Center Regensburg Recruiting
Regensburg, Germany
Italy
Instituto Nazionale Tumori Fondazione Pascale Recruiting
Naples, Italy
IOV Oncologico Veneto Padova Recruiting
Padivarma, Italy
Netherlands
Netherlands Cancer Institute - NKI Recruiting
Amsterdam, Netherlands
Poland
Jagiellonian University Medical College Krakow Recruiting
Krakow, Poland
Spain
Oncology Department Hospital of Navarre Recruiting
Navarra, Spain
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Vesna Bjelic-Radisic Medical University of Graz

Publications of Results:
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02979678     History of Changes
Other Study ID Numbers: 27-355
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medical University of Graz:
Breast cancer, quality of life