Health-related Quality of Life in General Slovenian Population

Health-related Quality of Life Clinical Trial

Official title:

Health-related Quality of Life in General Slovenian Poplation Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire QLQ-C30

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01269489
• Other study ID #: 134/09/09
• Status: Recruiting
• Phase: N/A
• First received: January 1, 2011
• Last updated: March 23, 2012
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: March 2012
• Source: Institute of Oncology Ljubljana
• Contact: Vaneja Velenik, PhD,MD
• Phone: +38615879661
• Email: vvelenik[@]onko-i.si
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 18 y and more

Exclusion Criteria:

• serious comorbidity

• previously treated for cancer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Health-related Quality of Life

Locations

Country	Name	City	State
Slovenia	Institute of Oncology	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

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. Review. — View Citation

Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. — View Citation