Health-related Quality of Life in General Slovenian Popul... | NCT01269489

Studies
Health-related Quality of Life in General Slovenian Population

NCT01269489

Sponsor

Institute of Oncology Ljubljana

Status

Unknown status

Last Update Posted

Mar 26, 2012Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Health-related Quality of Life

Interventions

Not provided

Countries

Slovenia

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

Mar 2012

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

Dec 2010

Primary Completion Date

Sep 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Jan 1, 2011

First Submission Date that Met QC Criteria

Jan 3, 2011

First Posted Date

Jan 4, 2011Estimated

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

Mar 23, 2012

Last Update Posted Date

Mar 26, 2012Estimated

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 the study is to obtain reference data on health-related quality of life for the functional and symptom scales and single items of the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a representative sample of Slovenian general population.

Detailed Description

A sample of at least 600 people from the Slovenian population, randomly selected, age 18 years and more, representing geografic diversity, will take part in this postal survey. The EORTC QLQ C30 and a questionnaire about demografic data will be send by mail. This is the first study to obtain reference data from the EORTC QLQ C30 in a sample from the general Slovenian population. The results will serve as guidelines for interpreting health-related quality-of-life of different groups of patients.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
general population		a representative sample from general Slovenian population

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 y and more

Exclusion Criteria:

serious comorbidity
previously treated for cancer

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

sample from general Slovenian population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vaneja Velenik, PhD,MD	Contact	+38615879661		vvelenik@onko-i.si
Vesna Zadnik, PhD,MD	Contact	+38615879661		vzadnik@onko-i.si

Overall Officials

Name	Affiliation	Role
Vaneja Velenik, PhD, MD	Institute of Oncology Ljubljana Slovenia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Oncology	Recruiting	Ljubljana		1000	Slovenia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18599286	Background	Cocks K, King MT, Velikova G, Fayers PM, Brown JM. Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials. Eur J Cancer. 2008 Sep;44(13):1793-8. doi: 10.1016/j.ejca.2008.05.008. Epub 2008 Jul 1.
11858978