Lung CancerNCT02745691
Psychometric Properties of the EORTC QLQ-LC29
An observational study of Lung Cancer, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients diagnosed with lung cancer. Participants will be enrolled in four groups according to their primary therapy (A. Surgery, B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Surgery, Radiochemotherapy and Targeted therapy
- How many people
- 523 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2016to 26 Sep 2018
- 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: Patients with histologically confirmed diagnosis of lung cancer
Who may be able to join
- histologically confirmed diagnosis of lung cancer
- no previous primary or recurrent tumour
- ability to understand the language of the questionnaire
- mental fitness to complete a questionnaire
- 18 years of age or above
- written informed consent.-
Who cannot join
- no histologically confirmed diagnosis of lung cancer-
- previous primary or recurrent tumour
- not mentally fit to complete a questionnaire
- not able to understand the language of the questionnaire
- younger than 18
- refusal of informed consent.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Clinical Studies, University Hospital Regensburg
Regensburg
About this study
Official title: An International Phase 4 Field Study for Analyzing the Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Lung Cancer (EORTC QLQ-LC29)
The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients diagnosed with lung cancer. Participants will be enrolled in four groups according to their primary therapy (A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy). According to sample size calculations the investigators will include a total of N = 450 patients, but inflating the recruitment goal is permissible.
Read the detailed description
Background The EORTC QLQ-C30 assesses quality of life of cancer patients and comprises 30 items that are grouped in five functional scales (physical, role, cognitive, emotional and social), one scale to rate global health and quality of life, three multi-item symptom scales (fatigue, nausea and vomiting, pain) and five single symptom items (dyspnoea, insomnia, appetite loss, constipation and diarrhea), one item assessing perceived financial impact of disease and treatment.
The updated lung cancer module, the QLQ-LC29, is a module to be used in conjunction with the QLQ-C30 for the assessment of specific aspects of quality of life in patients with lung cancer. All items are accompanied by the classic EORTC four-point Likert response scale with the labels 1 "not at all", 2 "a little", 3 "quite a bit", and 4 "very much". The time frame is the past week ("Please indicate the extent to which you have experienced these symptoms or problems during the past week").
Eligibility Patients are eligible for this study if they have a histologically confirmed diagnosis of lung cancer, are able to understand the language of the questionnaire, are mentally fit to complete the questionnaire, and have provided written informed consent.
Sampling matrix Participants will be enrolled in four groups according to their primary therapy: A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy. Various combinations of therapies are possible, resulting in a total of eight subgroups: A.1 Surgery alone and/or before any adjuvant therapy, A.2 Surgery (late effects), B.1 Chemotherapy alone, B.2 Radiotherapy alone, B.3 Sequential radiochemotherapy, B.4 Concurrent radiochemotherapy, C.1 Targeted therapy alone, C.2 Targeted therapy in combination with any other therapy, D. Immunotherapy.
Procedure Patients are informed about the goal of the study. After granting informed consent, patients fill in the self-administered paper version of the EORTC QLQ-C30 plus the new lung module QLQ-LC29. Their physicians provide the clinical documentation. A subsample of the patients will fill in the questionnaires at a second time point two to four weeks later.
Sample size According to sample size calculations we will include a total of N = 450 patients, but inflating the recruitment goal is permissible.
Statistical analyses Scale structure will be analysed by confirmatory factor analyses, and backed by classical test theory (convergent/discriminant validity). Reliability will be calculated by means of Cronbach's alpha (internal consistency) and intra-class coefficient (ICC, test-retest reliability). Sensitivity of the module will be assessed by means of known group differences (Karnofsky Performance Status). Responsiveness to change over time will take into account differences between the second and first assessment.
- Conditions
- Lung Cancer
- Being tested
- Surgery, Radiochemotherapy, Targeted therapy, Immunotherapy
- Keywords
- quality of life, psychometric validation, international field study, patient-reported outcome (PRO)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Thoracic surgery for lung cancer
RadiochemotherapyOther
Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)
Targeted therapyOther
Also called Bevacizumab, Erlotinib, Gefitinib, and Crizotinib
New targeted therapies for lung cancer
ImmunotherapyOther
New immunotherapies for lung cancer
| Study group | Role | What they receive |
|---|---|---|
| A. Surgery | A.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects) Receives: Other: Surgery | |
| B. Radiochemotherapy | B.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy Receives: Other: Radiochemotherapy | |
| C. Targeted therapy | C.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy Receives: Other: Targeted therapy | |
| D. Immunotherapy | Any new immunotherapy for lung cancer Receives: Other: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
QLQ-LC29
Self-reported symptoms related to lung cancer. Each item is rated on a response scale 1 = not at all to 4 = very much and refer to the time frame "during the past week"
Measured: In the course of therapy or up to three months after having completed therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start1 Apr 2016
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
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 Lung 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
- Prospective
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Koller, University Hospital Regensburg
- Investigators
- Michael Koller, PhD, Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745691
- Sponsor's protocol ID
- LC29_Phase4
- Status last verified
- Dec 2019
- First submitted
- 15 Apr 2016
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Koch M, Grafenstein L, Karnosky J, Schulz C, Koller M. Psychosocial Burden and Quality of Life of Lung Cancer Patients: Results of the EORTC QLQ-C30/QLQ-LC29 Questionnaire and Hornheide Screening Instrument. Cancer Manag Res. 2021 Aug 7;13:6191-6197. doi: 10.2147/CMAR.S314310. eCollection 2021.
PubMed 34393512Koller M, Shamieh O, Hjermstad MJ, Hornslien K, Young T, Chalk T, Ioannidis G, Harle A, Johnson CD, Tomaszewski KA, Serpentini S, Pinto M, van der Weijst L, Janssens A, Morag O, Chie WC, Arraras JI, Pompili C, Jungraithmayr W, Hechtner M, Katsochi D, Muller K, Grafenstein L, Schulz C, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group; EORTC Lung Cancer Group; European Society of Thoracic Surgeons. Psychometric properties of the updated EORTC module for assessing quality of life in patients with lung cancer (QLQ-LC29): an international, observational field study. Lancet Oncol. 2020 May;21(5):723-732. doi: 10.1016/S1470-2045(20)30093-0. Epub 2020 Mar 23.
PubMed 32213338
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Phase 4 Field Study for Analyzing the Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Lung Cancer (EORTC QLQ-LC29)
- ClinicalTrials.gov ID
- NCT02745691
- Acronym / sponsor ID
- LC29_Phase4
- Conditions
- Lung Cancer
- Keywords
- quality of life, psychometric validation, international field study, patient-reported outcome (PRO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 20 Apr 2016 (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 aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients diagnosed with lung cancer. Participants will be enrolled in four groups according to their primary therapy (A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy). According to sample size calculations the investigators will include a total of N = 450 patients, but inflating the recruitment goal is permissible.
Detailed description
Background The EORTC QLQ-C30 assesses quality of life of cancer patients and comprises 30 items that are grouped in five functional scales (physical, role, cognitive, emotional and social), one scale to rate global health and quality of life, three multi-item symptom scales (fatigue, nausea and vomiting, pain) and five single symptom items (dyspnoea, insomnia, appetite loss, constipation and diarrhea), one item assessing perceived financial impact of disease and treatment.
The updated lung cancer module, the QLQ-LC29, is a module to be used in conjunction with the QLQ-C30 for the assessment of specific aspects of quality of life in patients with lung cancer. All items are accompanied by the classic EORTC four-point Likert response scale with the labels 1 "not at all", 2 "a little", 3 "quite a bit", and 4 "very much". The time frame is the past week ("Please indicate the extent to which you have experienced these symptoms or problems during the past week").
Eligibility Patients are eligible for this study if they have a histologically confirmed diagnosis of lung cancer, are able to understand the language of the questionnaire, are mentally fit to complete the questionnaire, and have provided written informed consent.
Sampling matrix Participants will be enrolled in four groups according to their primary therapy: A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy. Various combinations of therapies are possible, resulting in a total of eight subgroups: A.1 Surgery alone and/or before any adjuvant therapy, A.2 Surgery (late effects), B.1 Chemotherapy alone, B.2 Radiotherapy alone, B.3 Sequential radiochemotherapy, B.4 Concurrent radiochemotherapy, C.1 Targeted therapy alone, C.2 Targeted therapy in combination with any other therapy, D. Immunotherapy.
Procedure Patients are informed about the goal of the study. After granting informed consent, patients fill in the self-administered paper version of the EORTC QLQ-C30 plus the new lung module QLQ-LC29. Their physicians provide the clinical documentation. A subsample of the patients will fill in the questionnaires at a second time point two to four weeks later.
Sample size According to sample size calculations we will include a total of N = 450 patients, but inflating the recruitment goal is permissible.
Statistical analyses Scale structure will be analysed by confirmatory factor analyses, and backed by classical test theory (convergent/discriminant validity). Reliability will be calculated by means of Cronbach's alpha (internal consistency) and intra-class coefficient (ICC, test-retest reliability). Sensitivity of the module will be assessed by means of known group differences (Karnofsky Performance Status). Responsiveness to change over time will take into account differences between the second and first assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A. Surgery | – | Other: SurgeryA.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects) |
| B. Radiochemotherapy | – | Other: RadiochemotherapyB.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy |
| C. Targeted therapy | – | Other: Targeted therapyC.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy |
| D. Immunotherapy | – | Other: ImmunotherapyAny new immunotherapy for lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed diagnosis of lung cancer
Key inclusion criteria (6 listed)
- histologically confirmed diagnosis of lung cancer
- no previous primary or recurrent tumour
- ability to understand the language of the questionnaire
- mental fitness to complete a questionnaire
- 18 years of age or above
Key exclusion criteria (6 listed)
- no histologically confirmed diagnosis of lung cancer-
- previous primary or recurrent tumour
- not mentally fit to complete a questionnaire
- not able to understand the language of the questionnaire
- younger than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryThoracic surgery for lung cancer | Other | A. Surgery |
| RadiochemotherapyEither chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent) | Other | B. Radiochemotherapy |
| Targeted therapyAlso: Bevacizumab, Erlotinib, Gefitinib, and CrizotinibNew targeted therapies for lung cancer | Other | C. Targeted therapy |
| ImmunotherapyNew immunotherapies for lung cancer | Other | D. Immunotherapy |
Primary outcome
QLQ-LC29
Time frame: In the course of therapy or up to three months after having completed therapy
Self-reported symptoms related to lung cancer. Each item is rated on a response scale 1 = not at all to 4 = very much and refer to the time frame "during the past week"
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 13 Dec 2019.
- Derived from this study: PubMed 34393512Koch M, Grafenstein L, Karnosky J, Schulz C, Koller M. Psychosocial Burden and Quality of Life of Lung Cancer Patients: Results of the EORTC QLQ-C30/QLQ-LC29 Questionnaire and Hornheide Screening Instrument. Cancer Manag Res. 2021 Aug 7;13:6191-6197. doi: 10.2147/CMAR.S314310. eCollection 2021.
- Derived from this study: PubMed 32213338Koller M, Shamieh O, Hjermstad MJ, Hornslien K, Young T, Chalk T, Ioannidis G, Harle A, Johnson CD, Tomaszewski KA, Serpentini S, Pinto M, van der Weijst L, Janssens A, Morag O, Chie WC, Arraras JI, Pompili C, Jungraithmayr W, Hechtner M, Katsochi D, Muller K, Grafenstein L, Schulz C, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group; EORTC Lung Cancer Group; European Society of Thoracic Surgeons. Psychometric properties of the updated EORTC module for assessing quality of life in patients with lung cancer (QLQ-LC29): an international, observational field study. Lancet Oncol. 2020 May;21(5):723-732. doi: 10.1016/S1470-2045(20)30093-0. Epub 2020 Mar 23.
- 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, PhD principal investigator
University Hospital Regensburg
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 Lung Cancer, 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 6 inclusion and 6 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 13 Dec 2019. 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-LC29 (time frame: In the course of therapy or up to three months after having completed therapy). 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 NCT02745691, 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 13 Dec 2019.