Psychometric Properties of the EORTC QLQ-LC29

December 11, 2019 updated by: Michael Koller, University Hospital Regensburg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

523

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany
        • Center for Clinical Studies, University Hospital Regensburg

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed diagnosis of lung cancer

Description

Inclusion Criteria:

  • 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.-

Exclusion Criteria:

  • 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.

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
Intervention / Treatment
A. Surgery
A.1 Surgery alone and/or before any adjuvant therapy A.2 Surgery (late effects)
Other: Surgery
Thoracic surgery for lung cancer
B. Radiochemotherapy
B.1 Chemotherapy alone B.2 Radiotherapy alone B.3 Sequential radiochemotherapy B.4 Concurrent radiochemotherapy
Other: Radiochemotherapy
Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)
C. Targeted therapy
C.1 Targeted therapy alone C.2 Targeted therapy in combination with any other therapy
Other: Targeted therapy
New targeted therapies for lung cancer
Other Names:
  • Bevacizumab, Erlotinib, Gefitinib, and Crizotinib
D. Immunotherapy
Any new immunotherapy for lung cancer
Other: Immunotherapy
New immunotherapies for lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
In the course of therapy or up to three months after having completed therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Regensburg

Investigators

  • Principal Investigator: Michael Koller, PhD, University Hospital Regensburg

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

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 (Actual)

April 1, 2016

Primary Completion (Actual)

September 26, 2018

Study Completion (Actual)

September 26, 2018

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 17, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC29_Phase4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Lung Cancer

Clinical Trials on Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe