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NCT01269489 Clinical Trial

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
Secondary ID
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

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

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