Validation of the european organization for research and treatment of cancer quality of life questionnaire (QLQ-C30) as a measure of psychosocial function in breast cancer patients

doi:10.1016/S0959-8049(97)10076-4

European Journal of Cancer

Volume 34, Issue 4, March 1998, Pages 510-517

https://doi.org/10.1016/S0959-8049(97)10076-4 Get rights and content

Abstract

The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30 has been developed as a quantitative measure of health-related quality of life for use in clinical trials of cancer patients. Validity is an important measurement property of all scientific tests. This study contributes to the iterative process of validating the questionnaire by focusing on the psychosocial subscales of the QLQ-C30, using baseline data from 150 patients participating in a randomised trial of supportive group therapy for metastatic breast cancer. The results provide strong support for the discriminative validity of the global health/quality of life, role function and social function subscales of the QLQ-C30, in patients differing according to clinical criteria. The psychosocial focus of the trial enabled expansion of criteria used to form patient subgroups, beyond medical factors, and consequently support was demonstrated for the discriminative validity of the emotional and cognitive function subscales. The degree of support for these subscales was less substantial than for the other QLQ-C30 subscales as there were fewer relevant criteria. Convergence assessed by correlations with independent measures of psychosocial function provides strong support for the convergent validity of the emotional function, role function and global health/quality of life subscales of the QLQ-C30, and moderate support for the social function subscales. There was little opportunity for the cognitive function subscale to associate with conceptually analagous subscales. Further testing is recommended with more comprehensive and specific measures of cognitive status. In general, the psychosocial subscales of the QLQ-C30 appear to be measuring the concepts they are purported to measure.

Introduction

Breast cancer is the second most frequent cause of cancer death among North American women1, 2. Metastatic breast cancer is incurable with currently available therapies, so the aim of treatment is to palliate symptoms, improve survival, and the quality of it. The benefits of cancer treatment should outweigh its cost in patient suffering.

Traditionally, treatment efficacy in breast cancer patients has been assessed in clinical trials using biomedical outcomes, such as tumour shrinkage, progression-free survival and treatment toxicity. These parameters may or may not correlate with patient benefit. Recently, it has been recognised that a more comprehensive assessment of the cancer patient is necessary and that the evaluation of outcomes must move beyond traditional biomedical endpoints to include assessments of the impact of disease and its treatment on patients’ quality of life.

The European Organization for Research and Treatment of Cancer (EORTC) has developed a 30-item quality of life questionnaire (QLQ-C30) which is a brief, self-reporting, cancer-specific measure of health-related quality of life (HRQL)[3]. Its purpose is to obtain information about the impact of disease and treatment on the daily living of cancer patients. The core, QLQ-C30, is composed of a number of subscales representing HRQL dimensions relevant across a wide range of cancer sites and treatment methods. It can be supplemented by diagnosis-specific and treatment-specific questionnaire modules[4].

To be useful in research and clinical applications, HRQL measures, like other scientific measures, must be relevant, quantifiable, reliable and valid. There is a growing literature supporting the reliability and validity of the QLQ-C303, 5, 6, 7, 8, 9, 10. These studies have focused on disease and treatment parameters such as performance status, chemotherapy, radiation treatment and stage of disease. The psychometric properties of the psychosocial subscales of the QLQ-C30 have not been well established. However, the QLQ-C30 is a multidimensional measure of HRQL and the focus of this study is on the items measured by the psychosocial subscales. We have defined the psychosocial subscales of the QLQ-C30 as those measuring role function, social function, cognitive function, emotional function and global/overall quality of life.

The reliability and validity of commonly employed psychological instruments is difficult to assess in cancer patients because somatic manifestations of psychological distress, such as fatigue, insomnia and anorexia, can also be attributed to disease or the treatment of it. As a compromise, selected items have been incorporated into multidimensional HRQL instruments to minimise respondent burden. The question is how well do abbreviated scales measure social and psychological functioning in cancer patients?

This study formally evaluates the construct validity of the psychosocial subscales of the QLQ-C30 in patients with metastatic breast cancer. The specific objectives were to examine the discriminative validity of the five psychosocial subscales and to evaluate their convergent validity.

Section snippets

Subjects

The data are based on the first 150 women participating in a Canadian multicentre, randomised trial designed to determine the effectiveness of Breast Expressive Supportive Therapy (BEST) in metastatic breast cancer[11]. Women were eligible to enter the BEST study if they had metastatic cancer beyond the breast and ipsilateral axilla, an expected survival of at least 3 months and the absence of serious psychiatric disorders (psychosis, untreated major depression, severe personality disorder).

Patient sociodemographic and clinical characteristics

Patient characteristics are summarised in Table 1. On average, patients had metastatic breast cancer for 12 months. They spoke English well enough to complete questionnaires and participate in group therapy. The majority of patients had a physician-estimated prognosis of greater than 12 months. Forty-five per cent had visceral sites of disease and approximately half the women had an Eastern Cooperative Oncology Group (ECOG) performance status rating of zero. Most were being treated actively

Discussion

The QLQ-C30 is a measure of HRQL, intended to be applicable across a wide range of cancer diagnoses and treatments. Breast cancer is a common malignancy and women with the disease represent a large portion of oncology patients. The QLQ-C30 has been evaluated in other diagnostic groups of patients and smaller subgroups of patients with heterogeneous cancers, including breast cancer. The results presented in this paper represent one of the largest validation studies involving metastatic breast

Acknowledgements

We would like to acknowledge the contributions of the following BEST study co-investigators: Coordinating Centre, Molyn Leszcz MD, John Hunter MD, Leslie Vincent RN, Kathy Pritchard MD; Ottawa Centre, Margaret Navarro MD, Paul Aucoin MSW, Shail Verma MD; Hamilton Centre, Julia Masterson MD, Helaine Guther MSW, Andrew Arnold MD; Winnipeg Centre, Harvey M, Chochinov MD, Barbara Warren RN; Edmonton Centre, Marilyn Hundleby PhD, Rami Sela PhD, Jean-Marc Nabholtz MD; Calgary Centre, Jan Koopmans

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Original PaperValidation of the european organization for research and treatment of cancer quality of life questionnaire (QLQ-C30) as a measure of psychosocial function in breast cancer patients

Abstract

Introduction

Section snippets

Subjects

Patient sociodemographic and clinical characteristics

Discussion

Acknowledgements

J Clin Epidemiol

A modular approach to quality-of-life assessment in clinical trials

Recent Results Cancer Res

Psychometric validation of the EORTC core quality of life questionnaire, 30-item version and a diagnosis-specific module for head and neck cancer patients

Acta Oncol

Psychometric properties and responsiveness of the EORTC quality of life questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer

Qual Life Res

Testing the EORTC quality of life questionnaire on cancer patients with heterogeneous diagnoses

Qual Life Res

Test–retest study of the European Organization for Research and Treatment of Cancer core quality of life questionnaire

J Clin Oncol

Psychometric validation of the EORTC core quality of life questionnaire, 30-item version and a diagnosis-specific module for head and neck cancer patients

Acta Oncol

A validation study of the domains of the core EORTC Quality of Life Questionnaire

Qual Life Res

Original Paper
Validation of the european organization for research and treatment of cancer quality of life questionnaire (QLQ-C30) as a measure of psychosocial function in breast cancer patients