CancerNCT05479682
Investigating the Equivalence of the EORTC QLQ-C30 and the QLQ-F17
An observational study of Cancer and Quality of Life, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
The EORTC QLQ-C30, a patient-reported outcome measure (PROM) that is available in 110 different languages, has been used in thousands of clinical cancer trials worldwide. The QLQ-C30 is composed of six functioning scales (including a measure for global quality of life), three symptom scales, and six single items. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Quality of Life
- How many people
- 2,672 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2023to 30 Mar 2023
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample will include patients with the following diagnoses: Breast, Lung, Colorectal, Prostate, Head\&Neck, Melanoma, Haematological, others The sample will include patients with the following treatment states: Active, Regular aftercare, Off (survivors, long-term survivors) The survey will be conducted in the following language regions: English-speaking countries: UK, US, Australia; West-Germanic language: German; Scandinavian language: Swedish; Slavic languages: Polish; Romance languages: French (France), Italian, Spanish (Spain), Romanian; Other European language: Finnish
Who may be able to join
- Patients suffering from cancer or in remission
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Clinical Studies, University Hospital Regensburg
Regensburg
About this study
The EORTC QLQ-C30, a patient-reported outcome measure (PROM) that is available in 110 different languages, has been used in thousands of clinical cancer trials worldwide. The QLQ-C30 is composed of six functioning scales (including a measure for global quality of life), three symptom scales, and six single items.
Researchers and regulatory bodies came up with the idea to construct a shortened EORTC questionnaire that solely consists of functioning scales and to use additional symptom items according to the side effect profile of the specific medication under investigation.
Read more
This shortened form termed QLQ-F17 includes the Physical Functioning (PF), Role Functioning (RF), Emotional Functioning (EF), Cognitive Functioning (CF), and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. This functioning questionnaire can be amended with symptom-specific items taken from the EORTC item library. This method provides a flexible and economic testing strategy that fits the demands of regulators and users in industry and academia.
It is an open question, however, whether the QLQ-F17 is equivalent to the QLQ-C30 in terms of measurement properties. Based on empirical research on response biases and order effects, one might argue that elimination of the symptoms between RF and CF-Dyspnea (DY), Pain (PA), Fatigue (FA), Insomnia (SL), Appetite (AP), Nausea/Vomiting (NV), Constipation (CO), and Diarrhea (DI)-and of the Financial difficulties (FI) item between SF and QL may alter the manner in which subsequent items are completed.
Thus, from a methodological point of view, it is essential to confirm the psychometric properties of the QLQ-F17 and to present evidence that scale values derived from the QLQ-F17 are equivalent to those of the QLQ-C30. Only in the case of equivalence may studies using either of the two basic questionnaires be compared directly. The present project is designed to address this research question.
This is an international multicenter survey study that will include respondents with cancer from Australia, Finland, France, Germany, Italy, Poland, Romania, Spain, Sweden, and United Kingdom. A randomized cross-over design will be applied, enabling between-patients as well as within-patients comparisons of the QLQ-C30 and the QLQ-F17. One group of respondents will first fill in the QLQ-C30 followed by the QLQ-F17, the other group will start with the QLQ-F17 followed by the QLQ-C30.
A sample size of 1.500 cancer patients is sufficient to get precise estimates with narrow confidence intervals regarding item and scale-level agreement. Thresholds and margins to be used for the analyses in this study will be consented by a statistical advisory group. Reliability and psychometric properties can also be precisely estimated with a sample of this size. The present study is based on the hypothesis that the QLQ-F17 and the QLQ-C30 questionnaires are equivalent.
- Conditions
- Cancer, Quality of Life
- Medical subject headings
- Neoplasms
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 |
|---|---|---|
| EORTC QLQ-C30 first, EORTC QLQ-F17 second | Intervention relates to the order of questionnaires to be completed. In this cohort, the EORTC QLQ-C30 will be completed first and after a short interim task the QLQ-F17 second. | |
| EORTC QLQ-F17 first, EORTC QLQ-C30 second | Intervention relates to the order of questionnaires to be completed. In this cohort, the order of questionnaires is reversed: EORTC QLQ-F17 will be completed first and after a short interim task the QLQ-C30 second. |
What is being measured
The primary outcome is the main question the study is designed to answer.
QLQ-C30
The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions
Measured: Day 1
QLQ-F17
The QLQ-F17 is the shortened version of the QLQ-C30 that is composed solely of items related to functioning, which include Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Feb 2023
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Cross-sectional
- Enrolment
- 2,672 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC, Kantar Health
- Responsible party
- Principal investigator, Michael Koller, University Hospital Regensburg
- Investigators
- Michael Koller, Prof. Dr., Principal investigator, Head of Center for Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479682
- Sponsor's protocol ID
- Z-2021-1709-7
- Status last verified
- May 2023
- First submitted
- 26 Jul 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeman F, Giesinger JM, Pukrop T, Petersen MA, Groenvold M, Nolte S, Kulis D, Shrestha S, Leysen L, Cocks K, Coens C, Ioannidis G, Pompili C, Koller M; of the EORTC QLG. The EORTC QLQ-F17 as a shortened version of the EORTC QLQ-C30 to assess self-reported functioning in cancer patients: investigating equivalence and psychometric properties in a randomized cross-over trial. EClinicalMedicine. 2025 Jun 3;84:103262. doi: 10.1016/j.eclinm.2025.103262. eCollection 2025 Jun.
PubMed 40521164
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Equivalence of the EORTC QLQ-C30 and the QLQ-F17
- ClinicalTrials.gov ID
- NCT05479682
- Acronym / sponsor ID
- Z-2021-1709-7
- Conditions
- Cancer, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,672 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC, Kantar Health
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- 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 EORTC QLQ-C30, a patient-reported outcome measure (PROM) that is available in 110 different languages, has been used in thousands of clinical cancer trials worldwide. The QLQ-C30 is composed of six functioning scales (including a measure for global quality of life), three symptom scales, and six single items.
Researchers and regulatory bodies came up with the idea to construct a shortened EORTC questionnaire that solely consists of functioning scales and to use additional symptom items according to the side effect profile of the specific medication under investigation.
This shortened form termed QLQ-F17 includes the Physical Functioning (PF), Role Functioning (RF), Emotional Functioning (EF), Cognitive Functioning (CF), and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. This functioning questionnaire can be amended with symptom-specific items taken from the EORTC item library. This method provides a flexible and economic testing strategy that fits the demands of regulators and users in industry and academia.
It is an open question, however, whether the QLQ-F17 is equivalent to the QLQ-C30 in terms of measurement properties. Based on empirical research on response biases and order effects, one might argue that elimination of the symptoms between RF and CF-Dyspnea (DY), Pain (PA), Fatigue (FA), Insomnia (SL), Appetite (AP), Nausea/Vomiting (NV), Constipation (CO), and Diarrhea (DI)-and of the Financial difficulties (FI) item between SF and QL may alter the manner in which subsequent items are completed.
Thus, from a methodological point of view, it is essential to confirm the psychometric properties of the QLQ-F17 and to present evidence that scale values derived from the QLQ-F17 are equivalent to those of the QLQ-C30. Only in the case of equivalence may studies using either of the two basic questionnaires be compared directly. The present project is designed to address this research question.
This is an international multicenter survey study that will include respondents with cancer from Australia, Finland, France, Germany, Italy, Poland, Romania, Spain, Sweden, and United Kingdom. A randomized cross-over design will be applied, enabling between-patients as well as within-patients comparisons of the QLQ-C30 and the QLQ-F17. One group of respondents will first fill in the QLQ-C30 followed by the QLQ-F17, the other group will start with the QLQ-F17 followed by the QLQ-C30.
A sample size of 1.500 cancer patients is sufficient to get precise estimates with narrow confidence intervals regarding item and scale-level agreement. Thresholds and margins to be used for the analyses in this study will be consented by a statistical advisory group. Reliability and psychometric properties can also be precisely estimated with a sample of this size. The present study is based on the hypothesis that the QLQ-F17 and the QLQ-C30 questionnaires are equivalent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EORTC QLQ-C30 first, EORTC QLQ-F17 second | – | –Intervention relates to the order of questionnaires to be completed. In this cohort, the EORTC QLQ-C30 will be completed first and after a short interim task the QLQ-F17 second. |
| EORTC QLQ-F17 first, EORTC QLQ-C30 second | – | –Intervention relates to the order of questionnaires to be completed. In this cohort, the order of questionnaires is reversed: EORTC QLQ-F17 will be completed first and after a short interim task the QLQ-C30 second. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will include patients with the following diagnoses: Breast, Lung, Colorectal, Prostate, Head\&Neck, Melanoma, Haematological, others The sample will include patients with the following treatment states: Active, Regular aftercare, Off (survivors, long-term survivors) The survey will be conducted in the following language regions: English-speaking countries: UK, US, Australia; West-Germanic language: German; Scandinavian language: Swedish; Slavic languages: Polish; Romance languages: French (France), Italian, Spanish (Spain), Romanian; Other European language: Finnish
Key inclusion criteria (1 listed)
- Patients suffering from cancer or in remission
Key exclusion criteria (1 listed)
- none
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
QLQ-C30
Time frame: Day 1
The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions
QLQ-F17
Time frame: Day 1
The QLQ-F17 is the shortened version of the QLQ-C30 that is composed solely of items related to functioning, which include Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 40521164Zeman F, Giesinger JM, Pukrop T, Petersen MA, Groenvold M, Nolte S, Kulis D, Shrestha S, Leysen L, Cocks K, Coens C, Ioannidis G, Pompili C, Koller M; of the EORTC QLG. The EORTC QLQ-F17 as a shortened version of the EORTC QLQ-C30 to assess self-reported functioning in cancer patients: investigating equivalence and psychometric properties in a randomized cross-over trial. EClinicalMedicine. 2025 Jun 3;84:103262. doi: 10.1016/j.eclinm.2025.103262. eCollection 2025 Jun.
- Individual participant dataSharing planned: No
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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.
Michael Koller, Prof. Dr. principal investigator
Head of Center for Clinical Trials
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 Cancer and Quality of Life, run by University Hospital Regensburg at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 9 May 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QLQ-C30 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479682, which also lists 1 linked publication.
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 9 May 2023.