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

NCT02979678 | Unknown

• 1 other identifier: 27-355
• Study Type: interventional
• Target: 260
• Locations: 8 countries
• Sites: 9

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.

Conditions

Quality of Life

Keywords

Breast cancer, quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Patients under Treatment are asked to complete the questionnaire

  3 years, Patients under treatment are asked once to complete the questionnaire during 3 years

Study Arms (1)

Questionnaire

EXPERIMENTAL

Breast cancer

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Also known as: EORTC QLQ-Breast Cancer Module Update

Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with early or metastatic breast cancer

You may not qualify if:

• Patients with second malignancy

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (9)

Medical University Graz

Graz, Austria

RECRUITING

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

Related Publications (2)

• Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.

  PMID: 8874337 RESULT

• Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Vesna Bjelic-Radisic

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vesna Bjelic-Radisic

CONTACT

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

Brigitte Bliem

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: December 1, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2019
• Last Updated: September 6, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); IT (2); AU (1); CR (1); PL (1); ES (1); DE (1); NL (1)