European Organisation of Research and Treatment (EORTC) Q... | NCT02979678

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

NCT02979678

Sponsor

Medical University of Graz

Status

Unknown status

Last Update Posted

Sep 6, 2017Actual

Enrollment

260Estimated

Phase

Not Applicable

Conditions

Quality of Life

Interventions

Questionnaire

Countries

Austria
Croatia
France
Germany
Italy
Netherlands
Poland
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Mar 2018Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Oct 13, 2016

First Submission Date that Met QC Criteria

Nov 29, 2016

First Posted Date

Dec 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2017

Last Update Posted Date

Sep 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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).
Operationalization of the issues into items; a provisional version of a the questionnaire and a hypothetic scale structure will be established (Phase2).
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).
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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Questionnaire	Experimental	Breast cancer	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	The questionnaire should be updated with respect to wording, terminology.	Questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with early or metastatic breast cancer

Exclusion Criteria:

Patients with second malignancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vesna Bjelic-Radisic	Contact	+43 316 385 80504		vesna.bjelic-radisic@medunigraz.at
Brigitte Bliem	Contact	+43 316 385 81426		brigitte.bliem@medunigraz.at

Overall Officials

Name	Affiliation	Role
Vesna Bjelic-Radisic	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Graz	Recruiting	Graz			Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8874337	Result	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.
	Result	Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms