- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01269489
Health-related Quality of Life in General Slovenian Population
March 23, 2012 updated by: Institute of Oncology Ljubljana
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
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vaneja Velenik, PhD,MD
- Phone Number: +38615879661
- Email: vvelenik@onko-i.si
Study Contact Backup
- Name: Vesna Zadnik, PhD,MD
- Phone Number: +38615879661
- Email: vzadnik@onko-i.si
Study Locations
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-
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Ljubljana, Slovenia, 1000
- Recruiting
- Institute of Oncology
-
Contact:
- Vaneja Velenik, PhD,MD
- Phone Number: +38615879661
- Email: vvelenik@onko-i.si
-
Contact:
- Vesna Zadnik, PhD,MD
- Phone Number: +3861 5879661
- Email: vzadnik@onko-i.si
-
Principal Investigator:
- Vaneja Velenik, PhD, MD
-
Sub-Investigator:
- Vesna Zadnik, PhD,MD
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Sub-Investigator:
- Danijela Strbac, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
sample from general Slovenian population
Description
Inclusion Criteria:
- age 18 y and more
Exclusion Criteria:
- serious comorbidity
- previously treated for cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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general population
a representative sample from general Slovenian population
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vaneja Velenik, PhD, MD, Institute of Oncology Ljubljana Slovenia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1016/s0959-8049(01)00448-8.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Anticipated)
September 1, 2012
Study Completion (Anticipated)
September 1, 2012
Study Registration Dates
First Submitted
January 1, 2011
First Submitted That Met QC Criteria
January 3, 2011
First Posted (Estimate)
January 4, 2011
Study Record Updates
Last Update Posted (Estimate)
March 26, 2012
Last Update Submitted That Met QC Criteria
March 23, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 134/09/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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