Quality of life research within the EORTC—the EORTC QLQ-C30

doi:10.1016/S0959-8049(01)00448-8

European Journal of Cancer

Volume 38, Supplement 4, March 2002, Pages 125-133

https://doi.org/10.1016/S0959-8049(01)00448-8 Get rights and content

Abstract

In forming its Quality of Life Group, the EORTC created one of the earliest and largest of such groups in Europe. The EORTC QLQ-C30 which this group developed has become the most widely used questionnaire in Europe for cancer patients, and is extensively used around the world. The Quality of Life Group continues to build upon this success, both by refining the QLQ-C30, whilst developing a range of additional modules, and by initiating research projects that explore aspects of quality of life assessment, evaluation and interpretation. We review the progress to date and indicate directions of further research and development.

Introduction

One of the principal functions of the European Organisation for Research and Treatment of Cancer (EORTC) is the execution of large, prospective, randomised, multicentre cancer clinical trials, covering the full range of cancer sites and therapies. Quality of life (QoL) has always been an important aspect of the EORTC approach to treatment as stated in the aims of the organisation: “to conduct, develop, coordinate, and stimulate laboratory and clinical research in Europe to improve the management of cancer and related problems by increasing survival, but also patients' quality of life.” Both cancer and its treatment are severely debilitating, and the need to consider their impact upon health-related QoL when making patient management or treatment decisions is nowadays well accepted. Given the current recognition of the importance of formal assessment of QoL, and the consequent proliferation of QoL questionnaires, it is interesting to note that as recently as 15 years ago there were hardly any validated instruments for patients' self-completion, and most of the few that were available focused narrowly upon the physical aspects of disease. Thus, the EORTC showed considerable foresight when creating the EORTC Quality of Life Group (QLG) in 1980 to advise the EORTC Data Center and the various cooperative groups on the design, implementation and analysis of QoL studies within selected phase III studies. The first major achievement of the EORTC QLG was in 1987, when the QLG developed its first generation core questionnaire, the EORTC Quality of Life Questionnaire-Core 36 (QLQ-C36). Throughout the years since then, the QLG has continued to build upon its initial successes, in particular taking advantage of its unique situation of having a multidisciplinary mix of members from diverse linguistic and cultural backgrounds.

The other crucial component in the EORTC strategy was the establishment in 1993 of the Quality of Life Unit (QLU) as a scientific and administrative unit within the EORTC Data Center. Initially, the creation of the QLU was a 2-year pilot project supported by the European Community, but the success led to its formal establishment in 1995. The main aim of the Unit is to advise on the design, implementation and management of QoL measurement across all EORTC clinical trials. The QLU supervises translations and undertakes distribution of the EORTC QoL instruments.

The EORTC QLG and QLU work in of close, daily collaboration, thus ensuring an optimal mix of scientific, business and administration activities.

In this article, we review the achievements to date of the QLG and QLU, and describe our future directions in research and development.

Section snippets

Quality of Life Group

From its inception, the QLG had a formally defined mission statement. This was:

•
To develop reliable instruments for measuring the quality of life of cancer patients participating in international clinical trials;
•
To advise the EORTC about the assessment of the multidimensional aspects of patients' QoL as a measurable outcome of cancer treatment;
•
To advise on the design, implementation and analysis of QoL studies within EORTC trials;
•
To conduct basic research in the methodology of QoL assessment;
•
To

Quality of Life Unit, EORTC Data Center, Brussels

The aims of the QLU are three-fold. Firstly, to evaluate the importance of various factors that improves the QoL of cancer patients. Secondly, to supervise the evaluation of QoL in selected cancer clinical trials. Thirdly, to encourage physicians to pay greater attention to quality of life factors in the treatment of cancer by stimulating, enhancing and co-ordinating the evaluation of quality of life in cancer clinical trials. The QLU is staffed by a team of professionals with experience in

EORTC QLQ-C30 development

The first generation of the EORTC quality of life questionnaire (QLQ) was developed by 1987. It was designed to be:

•
Cancer-specific;
•
Multidimensional in structure;
•
Appropriate for self-administration;
•
Applicable across a range of cultural settings;
•
Suitable for use with additional site- or treatment-specific modules.

The QLQ-C30 (version 1) incorporated five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global

EORTC QLQ-C30 modules

From the beginning, an essential part of our philosophy has been that the EORTC QLQ-C30 is a brief core measure for general use with cancer patients, and that it should be supplemented by additional modules. These, when employed in conjunction with the QLQ-C30, provide more detailed information relevant to evaluating the QoL in specific patient populations. A module may be developed to assess: (1) symptoms related to a specific tumour site (e.g. urinary symptoms in prostate cancer, or problems

EORTC QLQ-C30 translations

Another essential ingredient of our philosophy is that the QLQ-C30 and QLQ modules should be suitable for use in a wide range of languages and cultures, as found both within Europe and beyond. The QLQ-C30 (version 3) is currently available in 41 languages (Table 2), and each translation has been carefully developed and tested following strict and detailed guidelines that are documented in the QLG Translation Procedure Manual [19]. Any modules not initially developed in English are first

Using the QLQ-C30

Although the QLQ-C30 was primarily developed for use in clinical trials, it is now being used in a variety of other settings including cross-sectional surveys, longitudinal surveys, and individual patient management and monitoring.

Research

The continued development of the QLQ-C30 and an ever-increasing number of modules and translations remains a priority for the QLG. However, an equally important aspect of our programme is research into QoL assessment, analysis and interpretation. In addition to the topics already mentioned above (clinical significance and interpretation of QoL scores, use of touch-screens, and individual patient monitoring), the QLG and its members are working on a variety of ‘state-of-the art’ research issues.

Membership of the EORTC Quality of Life Group

Membership of the QLG is open to anyone who is willing to participate in and contribute to the Group's activities. The QLG holds meetings twice yearly, in April and November. The main plenary sessions on Friday and Saturday are open to visitors and new members, whilst on Thursday there are closed working sessions for the QLG's ‘active members’. The plenary sessions discuss our ongoing research and development, and also offer scientific presentations of general interest. We encourage visitors to

For more information

Detailed and up-to-date information on the products and activities of both QLG and QLU are available at our Website (www.eortc.be/home/qol/). Copies of QLG manuals may be obtained from the QLU by writing or visiting the website.

All users must register their studies with the EORTC Quality of Life Unit. The QLQ-C30 and modules are available free of charge to academic groups for non-profit making research. Permission to use the QLQ-C30 or the QLQ modules is available through the QLU.

References (29)

K. Bjordal et al.
A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (the EORTC QLQ-H&N35)
Eur. J. Cancer
(2000)
B. Bergman et al.
The EORTC QLQ-LC13a modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials
Eur. J. Cancer
(1994)
J.M. Blazeby et al.
Development of an EORTC questionnaire module to be used in quality of life assessment for patients with oesophageal cancer. The EORTC Quality of Life Study Group
Eur. J. Cancer
(1996)
A. Cull et al.
Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trialsa progress report
Eur. J. Cancer
(2001)
M.A.G. Sprangers et al.
The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38)
Eur. J. Cancer
(1999)
C.W. Vickery et al.
Development of an EORTC disease specific quality of life module for use in patients with gastric cancer
Eur. J. Cancer
(2001)
D. Fitzsimmons et al.
Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer
Eur. J. Cancer
(1999)
R. Schwarz et al.
Reference data for the quality of life questionnaire EORTC QLQ-C30 in the general German population
Eur. J. Cancer
(2001)
P.M. Fayers
Interpreting quality of life datapopulation-based reference data for the EORTC QLQ-C30
Eur. J. Cancer
(2001)
N.K. Aaronson et al.
The European Organization for Research and Treatment of Cancer QLQ-C30a quality-of-life instrument for use in international clinical trials in oncology
J. Natl. Cancer Inst.
(1993)

N.K. Aaronson et al.

The European Organization for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncologyan update

P.M. Fayers et al.

EORTC QLQ-C30 Scoring Manual

(2001)

Fayers PM, Weeden S, Curran D, on behalf of the EORTC Quality of Life Study Group. EORTC QLQ-C30 Reference Values....

M.A. Sprangers et al.

The European Organization for Research and Treatment of Cancer approach to developing questionnaire modulesan update and overview

Qual. Life Res.

(1998)

Cited by (583)

Chemotherapy-Induced Peripheral Neuropathy (CIPN) as a Predictor of Decreased Quality of Life in Testicular Germ Cell Tumor Survivors
2024, Clinical Genitourinary Cancer
Chemotherapy-induced peripheral neuropathy (CIPN) after curative treatment for testicular germ cell tumors (GCTs) has been previously reported. It has been shown that CIPN can contribute to impaired quality of life (QOL) in cancer survivors. Herein, we aimed to evaluate CIPN in association with QOL in GCT survivors.
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life - Chemotherapy-Induced Peripheral Neuropathy questionnaire (QLQ-CIPN20) and Quality of Life Questionnaire (QLQ-C30) were prospectively completed by GCT survivors (N = 151) at National Cancer Institute in Slovakia during their annual follow-up. The median follow-up was 10 years (range 4-30). Upon obtaining the scores from each questionnaire, each score from QLQ-C30 was correlated with CIPN defined as high or low (above and below median) as obtained from CIPN20.
GCT survivors with high overall CIPN score reported impaired QOL in QLQ-C30. The global health status was lower in survivors with high CIPN versus low CIPN (mean score ± SEM: 67.17 ± 2.00 vs. 86.18 ± 1.76, P < .00001). Survivors with high CIPN reported worse physical, role, emotional, cognitive, and social functioning compared to survivors with low CIPN (all P < .00001). CIPN high survivors perceived more fatigue, nausea, pain, dyspnea, sleeping disorders, and appetite loss compared to CIPN low survivors (all P < .004). Higher burden of CIPN was associated with more financial problems vs CIPN low (mean score ± SEM: 19.70 ± 2.64 vs. 6.67 ± 2.32, P = .00025). Spearman analysis has confirmed negative correlation of overall CIPN20 score with QLQ-C30 global health status (R = −0.53, P < .0001).
CIPN is a strong predictor of impairment in QOL among GCT survivors. Molecular mechanisms of neurotoxicity should be intensively studied to find preventive and therapeutic strategies.
The socioeconomic impact of cancer on patients and their relatives: Organisation of European Cancer Institutes task force consensus recommendations on conceptual framework, taxonomy, and research directions
2024, The Lancet Oncology
Loss of income and out-of-pocket expenditures are important causes of financial hardship in many patients with cancer, even in high-income countries. The far-reaching consequences extend beyond the patients themselves to their relatives, including caregivers and dependents. European research to date has been limited and is hampered by the absence of a coherent theoretical framework and by heterogeneous methods and terminology. To address these shortages, a task force initiated by the Organisation of European Cancer Institutes (OECI) produced 25 recommendations, including a comprehensive definition of socioeconomic impact from the perspective of patients and their relatives, a conceptual framework, and a consistent taxonomy linked to the framework. The OECI task force consensus statement highlights directions for future research with a view towards policy relevance. Beyond descriptive studies into the dimension of the problem, individual severity and predictors of vulnerability should be explored. It is anticipated that the consensus recommendations will facilitate and enhance future research efforts into the socioeconomic impact of cancer and cancer care, providing a crucial reference point for the development and validation of patient-reported outcome instruments aimed at measuring its broader effects.
The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool; a validity and reliability study
2024, European Journal of Surgical Oncology
Follow-up care after treatment for colorectal cancer (CRC) is increasingly focused on health-related quality of life (HRQoL) and functional outcomes. The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool is developed to measure these outcomes and support patient-oriented care. The tool comprises items assessing burden of disease and lifestyle parameters. It consists of a generic module combined with one of the three CRC specific modules. The objective of this study is to assess the construct validity and reliability of the items of the ABCRC-tool.
Patients who were receiving follow-up care after surgical CRC treatment were invited to complete the ABCRC-tool together with other validated patient-reported outcome measures (PROMs). Construct validity was assessed by testing expected correlations between items of the ABCRC-tool and domains of other PROMs and by examining predefined hypotheses regarding differences in subgroups of patients. Patients completed the ABCRC-tool twice, with 8 days apart, to evaluate its reliability.
In total, 177 patients participated (64% male) with a mean age of 67 years (range 33–88). The colon, rectum and stoma module were completed by subsequently 89, 53 and 35 patients. Most items correlated as expected with anticipated domains of the EORTC QLQ-C30 or EORTC QLQ-CR29 (all p-values <0.05). Furthermore, the ABCRC-tool could discriminate between subgroups of patients. The intraclass correlation coefficient (ICC) was good (>0.70) for most items, indicating good reliability.
The ABCRC-tool is a valid and reliable instrument that is ready for use in a clinical setting to support personalized follow-up care after CRC treatment.
High-dose chemotherapy and autologous haematopoietic stem-cell transplantation in older, fit patients with primary diffuse large B-cell CNS lymphoma (MARTA): a single-arm, phase 2 trial
2024, The Lancet Haematology
Available treatments for older patients with primary diffuse large B-cell CNS lymphoma (PCNSL) offer progression-free survival of up to 16 months. We aimed to investigate an intensified treatment of high-dose chemotherapy and autologous haematopoietic stem-cell transplantation (HSCT) in older patients with PCNSL.
MARTA was a prospective, single-arm, phase 2 study done at 15 research hospitals in Germany. Patients aged 65 years or older with newly diagnosed, untreated PCNSL were enrolled if they had an Eastern Cooperative Oncology Group performance status of 0–2 and were fit for high-dose chemotherapy and autologous HSCT. Induction treatment consisted of two 21-day cycles of high-dose intravenous methotrexate 3·5 g/m² (day 1), intravenous cytarabine 2 g/m² twice daily (days 2 and 3), and intravenous rituximab 375 mg/m² (days 0 and 4) followed by high-dose chemotherapy with intravenous rituximab 375 mg/m² (day –8), intravenous busulfan 3·2 mg/kg (days –7 and –6), and intravenous thiotepa 5 mg/kg (days –5 and –4) plus autologous HSCT. The primary endpoint was progression-free survival at 12 months in all patients who met eligibility criteria and started treatment. The study was registered with the German clinical trial registry, DRKS00011932, and recruitment is complete.
Between Nov 28, 2017, and Sept 16, 2020, 54 patients started induction treatment and 51 were included in the full analysis set. Median age was 71 years (IQR 68–75); 27 (53%) patients were female and 24 (47%) were male. At a median follow-up of 23·0 months (IQR 16·8–37·4), 23 (45%) of 51 patients progressed, relapsed, or died. 12-month progression-free survival was 58·8% (80% CI 48·9–68·2; 95% CI 44·1–70·9). During induction treatment, the most common grade 3–5 toxicities were thrombocytopenia and leukopenia (each in 52 [96%] of 54 patients). During high-dose chemotherapy and autologous HSCT, the most common grade 3–5 toxicity was leukopenia (37 [100%] of 37 patients). Treatment-related deaths were reported in three (6%) of 54 patients, all due to infectious complications.
Although the primary efficacy threshold was not met, short induction followed by high-dose chemotherapy and autologous HSCT is active in selected older patients with PCNSL and could serve as a benchmark for comparative trials.
Else Kröner-Fresenius Foundation, Riemser Pharma, and Medical Center—University of Freiburg.
Optimizing lung cancer radiation therapy: A systematic review of multifactorial risk assessment for radiation-induced lung toxicity
2024, Cancer Treatment Reviews
Radiation therapy (RT) is essential in treating advanced lung cancer, but may lead to radiation pneumonitis (RP). This systematic review investigates the use of pulmonary function tests (PFT) and other parameters to predict and mitigate RP, thereby improving RT planning.
A systematic review sifted through PubMed and on BioMed Central, targeting articles from September 2005 to December 2022 containing the keywords: Lung Cancer, Radiotherapy, and pulmonary function test.
From 1153 articles, 80 were included. RP was assessed using CTCAEv.4 in 30 % of these. Six studies evaluated post-RT quality of life in lung cancer patients, reporting no decline. Patients with RP and chronic obstructive pulmonary disease (COPD) generally exhibited poorer overall survival. Notably, forced expiratory volume in one second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO) declined 24 months post-RT, while forced vital capacity (FVC) stayed stable. In the majority of studies, age over 60, tumors located in the lower part of the lung, and low FEV1 before RT were associated with a higher risk of RP. Dosimetric factors (V5, V20, MLD) and metabolic imaging emerged as significant predictors of RP risk. A clinical checklist blending patient and tumor characteristics, PFT results, and dosimetric criteria was proposed for assessing RP risk before RT.
The review reveals the multifactorial nature of RP development following RT in lung cancer. This approach should guide individualized management and calls for a prospective study to validate these findings and enhance RP prevention strategies.
Tislelizumab versus chemotherapy as second-line treatment for European and North American patients with advanced or metastatic esophageal squamous cell carcinoma: a subgroup analysis of the randomized phase III RATIONALE-302 study
2024, ESMO Open
The phase III RATIONALE-302 study evaluated tislelizumab, an anti-programmed cell death protein 1 antibody, as second-line (2L) treatment for advanced/metastatic esophageal squamous cell carcinoma (ESCC). This prespecified exploratory analysis investigated outcomes in patients from Europe and North America (Europe/North America subgroup).
Patients with tumor progression during/after first-line systemic treatment were randomized 1 : 1 to open-label tislelizumab or investigator’s choice of chemotherapy (paclitaxel, docetaxel, or irinotecan).
The Europe/North America subgroup comprised 108 patients (tislelizumab: n = 55; chemotherapy: n = 53). Overall survival (OS) was prolonged with tislelizumab versus chemotherapy (median: 11.2 versus 6.3 months), with a hazard ratio (HR) of 0.55 [95% confidence interval (CI) 0.35-0.87]; HR was similar irrespective of programmed death-ligand 1 score [≥10%: 0.47 (95% CI 0.18-1.21); <10%: 0.55 (95% CI 0.30-1.01)]. Median progression-free survival was 2.3 versus 2.7 months with tislelizumab versus chemotherapy [HR: 0.97 (95% CI 0.64-1.47)]. Overall response rate was greater with tislelizumab (20.0%) versus chemotherapy (11.3%), with more durable response (median duration of response: 5.1 versus 2.1 months). Tislelizumab had a favorable safety profile versus chemotherapy, with fewer patients experiencing ≥grade 3 treatment-related adverse events (13.0% versus 51.0%). Those on tislelizumab experienced less deterioration in health-related quality of life, physical functioning, and/or disease- and treatment-related symptoms (i.e. fatigue, pain, and eating problems) as compared to those on chemotherapy, per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and QLQ-OES18 scores.
As a 2L therapy for advanced/metastatic ESCC, tislelizumab improved OS and had a favorable safety profile as compared to chemotherapy in European/North American ESCC patients in the randomized phase III RATIONALE-302 study.

View all citing articles on Scopus

View full text

Quality of life research within the EORTC—the EORTC QLQ-C30

Abstract

Introduction

Section snippets

Quality of Life Group

Quality of Life Unit, EORTC Data Center, Brussels

EORTC QLQ-C30 development

EORTC QLQ-C30 modules

EORTC QLQ-C30 translations

Using the QLQ-C30

Research

Membership of the EORTC Quality of Life Group

For more information

Eur. J. Cancer

Eur. J. Cancer

Eur. J. Cancer

Eur. J. Cancer

Eur. J. Cancer

Eur. J. Cancer

Eur. J. Cancer

Eur. J. Cancer

Eur. J. Cancer

The European Organization for Research and Treatment of Cancer QLQ-C30a quality-of-life instrument for use in international clinical trials in oncology

J. Natl. Cancer Inst.

The European Organization for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncologyan update

EORTC QLQ-C30 Scoring Manual

The European Organization for Research and Treatment of Cancer approach to developing questionnaire modulesan update and overview

Qual. Life Res.