Elsevier

European Journal of Cancer

Volume 45, Issue 17, November 2009, Pages 3017-3026
European Journal of Cancer

Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer

https://doi.org/10.1016/j.ejca.2009.08.014Get rights and content

Abstract

This international study aimed to test the measurement properties of the updated European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal cancer, the QLQ-CR29.

The QLQ-CR29 was administered with the QLQ-C30, core questionnaire, to 351 patients from seven countries. Questionnaire scaling and reliability were established and clinical and psychometric validity examined. Patient acceptability and understanding were assessed with a debriefing questionnaire.

Multi-trait scaling analyses and face validity refined the module to four scales assessing urinary frequency, faecal seepage, stool consistency and body image and single items assessing other common problems following treatment for colorectal cancer. Scales distinguished between clinically distinct groups of patients and did not correlate with QLQ-C30 scales, demonstrating construct validity. The QLQ-CR29 scores were reproducible over time in stable health.

The EORTC QLQ-CR29 demonstrates sufficient validity and reliability to support its use to supplement the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings.

Introduction

Colorectal cancer is the second commonest cause of cancer-related deaths in the developed world. Surgical resection provides the best hope of cure, and a modest additional survival benefit can be gained from adjuvant chemotherapy.1 Pre-operative radiotherapy for rectal cancer has been shown to improve local disease control.2 In trials of treatment for colorectal cancer standard outcomes include toxicity scores, surgical-related morbidity, local recurrence rates, disease free survival and overall survival, but over the past decade there had been an increasing focus on supplementing clinical outcomes with outcomes reported by the patients themselves. Assessing the patient’s perspective of outcome can be achieved with patient-reported outcome measures (PROMs) including health-related quality of life (HRQL) questionnaires. Generic tools to assess HRQL in cancer patients have been developed and these include the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 and the Functional Assessment of Cancer Therapy General scale (FACT-G).3, 4 Both core measures may be supplemented with disease specific modules.5, 6 These assess important issues such as bowel, bladder and sexual dysfunction and problems relating to stoma formation.

The EORTC QLQ-CR38 was developed originally in the Netherlands and it has been widely used in many trials and research settings.5 Although some psychometric data have been published, it was never formally validated in an international setting.5, 7, 8 Work to revise the QLQ-CR38 began a few years ago and a shorter questionnaire, the QLQ-CR29, was developed.9 The aims of this present study are to examine the psychometric properties of the EORTC QLQ-CR29 in an international field study and to validate it for use in clinical trials in patients with colorectal cancer.

Section snippets

Patients

This multi-centre study opened in March 2007 and closed in October 2008. Participants over the age of 18 years, with a histological diagnosis of adenocarcinoma of the colon or rectum were included and those with concurrent malignancy, or a psychological or linguistic impairment that hampered completion of the questionnaires were excluded. Ethics committee approval and written informed consent were obtained and the protocol was approved by the EORTC Quality of Life Group.

Questionnaires

The participants

Patient characteristics, compliance rates and questionnaire feasibility

Three hundred and fifty-one patients from seven countries were enrolled (Table 2). Baseline questionnaires were returned from all and the majority of patients (83%) completed the QLQ-C30 and QLQ-CR29 in less than 15 min, although 28% required some help with questionnaire completion. Debriefing questionnaires were completed by 344 (98%), and 14 (4%) reported that the sexual function items were not relevant. Another 36 (10%) reported that some questions were difficult to answer. No items were

Discussion

This study tested the EORTC QLQ-CR29 in an international sample of patients with colorectal cancer. Combined psychometric and clinical analyses led to a revision of the hypothesised scales and confirmed the single items. Further testing demonstrated that this module was reliable, not overlapping with HRQL issues in the core questionnaire and able to discriminate between known groups of patients with colorectal cancer. Debriefing information did not identify any major omissions and most

Conflicts of interest statement

None declared.

Acknowledgements

This study was supported by a grant from the EORTC Quality of Life Group. In Berlin the study was supported by a research grant from Deutsche Krebshilfe, Bonn, Germany. We acknowledge Francesca New, in Southampton and Isabelle Léonard in Nancy, who helped to collect the quality of life data. We thank Mr. Michael Thomas, Mr. Paul Sylvester, Mr. Robert Longman and Mr. Paul Durdey from University Hospitals Bristol NHS Foundation Trust and Mr. Tony Dixon from North Bristol Trust for allowing us to

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