Health-related Quality of LifeNCT01269489
Health-related Quality of Life in General Slovenian Population
An observational study of Health-related Quality of Life, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Health-related Quality of Life
- How many people
- 600 participants
- Where
- 1 siteSlovenia
- Study dates
- Dec 2010to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: sample from general Slovenian population
Who may be able to join
- age 18 y and more
Who cannot join
- serious comorbidity
- previously treated for cancer
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology
Ljubljana, 1000
Vaneja Velenik, PhD,MD, +38615879661, vvelenik@onko-i.si
Vesna Zadnik, PhD,MD, +3861 5879661, vzadnik@onko-i.si
About this study
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
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.
Read the 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.
- Conditions
- Health-related Quality of Life
- Keywords
- quality of life, general Slovenian population, EORTC QLQ C30
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| general population | a representative sample from general Slovenian population |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health-related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Investigators
- Vaneja Velenik, PhD, MD, Principal investigator, Institute of Oncology Ljubljana Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269489
- Sponsor's protocol ID
- 134/09/09
- Status last verified
- Mar 2012
- First submitted
- 1 Jan 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18599286Fayers 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.
PubMed 11858978
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01269489
- Acronym / sponsor ID
- 134/09/09
- Conditions
- Health-related Quality of Life
- Keywords
- quality of life, general Slovenian population, EORTC QLQ C30
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general population | – | –a representative sample from general Slovenian population |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- sample from general Slovenian population
Key inclusion criteria (1 listed)
- age 18 y and more
Key exclusion criteria (2 listed)
- serious comorbidity
- previously treated for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Background: PubMed 18599286Cocks 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.
- Background: PubMed 11858978Fayers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaneja Velenik, PhD, MD principal investigator
Institute of Oncology Ljubljana Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health-related Quality of Life, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vaneja Velenik, PhD,MD (+38615879661, vvelenik@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269489, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.