International validation of the EORTC QLQ-CAX24
Research type
Research Study
Full title
An international field study for the reliability and validity of the EORTC cancer cachexia module (the EORTC QLQ-CAX24) and the EORTC QLQ-C30 for assessing quality of life in cancer patients with cachexia
IRAS ID
193682
Contact name
Colin Johnson
Contact email
Sponsor organisation
Southampton University Hospitals NHS Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Our research group has recently developed a new questionnaire, called the QLQ-CAX24. This questionnaire will be used together with the QLQ-C30 to measure quality of life in people who have cancer cachexia in clinical trials, other research projects and clinical practice. The QLQ-C30 is a questionnaire for any patient with cancer and the QLQ-CAX24 has questions specifically related to cachexia. Cachexia is a complex problem involving changes to how the body works. The most obvious symptom is weight loss. Muscle, as well as fat, is lost so patients with cachexia feel weak and fatigued. In this study, we will test the validity of the QLQ-CAX24 in the UK and across the world. We will invite about 600 people with cancer cachexia to complete the QLQ-CAX24 and QLQ-C30. Study participation will take less than 30 minutes. We will include a wide variety of participants to make sure the QLQ-CAX24 works well patients who have different types of cancer, at different stages of disease and who are affected to different degrees by related symptoms. We will also include 50 cancer patients who do not have cachexia at the start of the study as a comparison group. Some participants with cancer cachexia who are clinically stable will be asked to complete the questionnaires twice, one week apart, to check the QLQ-CAX24 is reliable. Other participants who change clinically, including the patients without cachexia at the start of the study, will be asked to complete the questionnaires again a month or more after the first set. If their answers change, as predicted, this will show that the QLQ-CAX24 is responsive. A number of statistical tests will check the structure and properties of the QLQ-CAX24 to further explore its validity but, most importantly, participants will be asked for their feedback.
REC name
London - Stanmore Research Ethics Committee
REC reference
16/LO/0104
Date of REC Opinion
11 Jan 2016
REC opinion
Favourable Opinion