Elsevier

European Journal of Cancer

Volume 40, Issue 16, November 2004, Pages 2439-2444
European Journal of Cancer

Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18

https://doi.org/10.1016/j.ejca.2004.06.033Get rights and content

Abstract

Measurement of quality of life (QoL) in hepatocellular carcinoma (HCC) requires assessment of factors related to chronic liver disease, as well as issues related to the primary tumour and its treatment. This study describes the development of a questionnaire module in patients from Europe, as well as Taiwan and Hong Kong. The questionnaire was developed according to the European Organisation for Research and Treatment of Cancer (EORTC) QoL Group guidelines. Twenty nine QoL issues were identified from a literature search. Semi-structured interviews with patients (n = 32) and health-care professionals (n = 10) reduced the issues to 22 items forming a provisional questionnaire. This was tested in 158 patients from three countries. Descriptive statistics and clinical judgement reduced the module to 18 items conceptualised as containing six scales and two single item. This study recommends the EORTC QLQ-HCC18 to accompany the QLQ-C30 to measure QoL in clinical trials in HCC.

Introduction

Hepatocellular carcinoma (HCC) is one of the world’s most common malignancies, with a marked heterogeneous geographical distribution [1]. In high-risk areas, such as Asia and Africa, annual incidence rates are between 10 and 120 per 100,000 population, whereas in low-risk areas, Northern Europe, United States of America (USA) and India, annual incidence rates are below 3 per 100,000 population [1]. Over the past decade, advances in diagnostic techniques and multi-disciplinary management of HCC have led to small improvements in survival, although outcomes remains poor with overall one year survival being less than 20% [2], [3]. Trials evaluating systemic chemotherapy show very little benefit [4]. Local arterial infusion of cytotoxic agents or cytotoxic agents in combination with lipiodol may increase survival in well selected patients [5], [6]. Percutaneous approaches with ethanol, or radiofrequency ablation can be used for unresectable HCC and there is currently interest in the role of octreotide [7]. Potentially curative treatments, including resection, percutaneous ablation or liver transplantation can be offered to patients with small lesions confined to the liver and five year survival may reach 50% [5]. Treatment strategies are aimed at incorporating prognosis estimation with potential treatment advancements [8]. Although survival data and information about the side-effects of treatment are widely available, much less is known about how treatment for HCC impacts upon patients’ health-related quality of life (QoL). Self-reported QoL data includes measures of physical, social and emotional well-being and this is valuable for patients and clinicians in decision-making [9]. Self-reported health data may also predict survival in patients with cancer and in other populations [10].

The most widely used instruments in assessing QoL in cancer patients within the context of clinical trials are the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the Functional Assessment of Cancer Therapy (FACT) generic questionnaire [11], [12]. These both use a general core questionnaire and may be supplemented by disease-specific modules. A module for hepatobiliary cancers has been published by the FACT group [13]. This is designed for patients with cancer of the head of pancreas, colorectal liver metastases, primary liver cancer and cholangiocarcinoma. It has 18 items that may be aggregated to produce a FACT-Hep scale. The EORTC group has taken a more focused approach, by developing separate modules for pancreatic cancer, colorectal hepatic metastases and primary liver cancer [14], [15]. This approach was followed because these cancers have different aetiologies, epidemiology, clinical problems, treatments and disease progression. This paper describes the development of the EORTC questionnaire, module to accompany the EORTC QLQ-C30 to comprehensively assess QoL in patients with HCC.

Section snippets

Study design

The development of the provisional module was performed according to the EORTC Quality of Life Group (QLG) published guidelines for questionnaire development [16], [17], [18]. These guidelines are summarised in Table 1. The final part of module development (Phase 4) consists of psychometric testing and is not part of this paper.

Subjects

Patients for the interviews carried out in Phase 1 were recruited from the United Kingdom (UK), The Chinese University of Hong Kong and Egypt. In Phase 3 of the study,

Literature search

Literature searches were performed in three databases: MEDLINE (1966–June 2002), EMBASE (1980–June 2002), and CINAHL (1982–April 2002). The searches were limited to the English language. The major subject heading, HCC was combined with surgery, QoL, questionnaires, chemotherapy, alcohol ablation, chemoembolisation, physical distress, psychological distress, psychosocial distress and physical symptoms. This identified 2055 articles. Nine papers described QoL questionnaires used with patients

Discussion

The EORTC QLQ-HCC18 has been methodologically developed using standard guidelines. It is designed for use with the QLQ-C30 core instrument to assess all major dimensions of health-related QoL in patients with HCC. The content of the questionnaire has been derived not only from the published literature, but also from health professionals dealing with these patients and, most importantly, from the patients themselves. Testing the QLQ-HCC18 in 158 patients from the UK, Taiwan and Hong Kong

Conflict of Interest Statement

None declared.

Acknowledgements

The authors acknowledge D. Alderson, M.D. Finch-Jones, R. Jones and F. Gordon (Bristol Royal Infirmary) for allowing us to study patients under their care. We are grateful to Mr. N. Dowidar (Egypt) for his contribution to the early Phase 1 part of the study. The authors are grateful to G. Velikova, T. Conroy, M. Sprangers, D. Osoba and E. Greimel, members of the EORTC Quality of Life Group who reviewed the development of this module. This work was sponsored by the EORTC Quality of Life Group,

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