EORTC H&N Phase IV
Research type
Research Study
Full title
An international phase IV field study for the reliability and validity of the EORTC Head and Neck Cancer Module H&N43
IRAS ID
158874
Contact name
Teresa Young
Contact email
Sponsor organisation
East & North Hertfordshire NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
The European Organisation for Research into Treatment of Cancer Quality of Life Group (EORTC QLG) has a remit to develop quality of life questionnaires/modules which are specific for diseases or quality of life domains (e.g. lung cancer, pain). The development process follows a standard four phase procedure documented in “Guidelines for Developing Questionnaire Modules (EORTC QLG)”.
In the 1990s the EORTC QLG Head and Neck Cancer module was developed (EORTC QLQ-H&N35). It contains 35 questions relating to how the disease itself, and its treatments, affects body functions, most notably breathing, swallowing, and speaking. As these functions are highly relevant, head and neck cancer can cause significant physical, emotional and social problems, reducing quality of life considerably.
Standard treatments of head and neck cancer have evolved during the past decades with new drugs and new schedules for chemotherapy and radiotherapy in combination. A revised module has been developed following two systematic literature reviews, extensive patient and professional interviews and pilot testing. (Phases I –III), resulting in the EORTC QLQ-H&N43. This application relates to the final validation study in the UK and is part of a larger international study. The questionnaire will be given to a large number of patients and their responses collected. Psychometric analysis of the data will be used to confirm the questionnaire has relevant content, is sensitive to changes in the patient’s condition (e.g. during treatment) and is reliable (i.e. if there is no change in the patient’s condition between appointments they give similar responses a few weeks later.)
All stages are conducted with international collaborators to ensure language and cross cultural issues are considered from the outset. This application only relates to Phase IV and to English speaking patients recruited in the UK.
Summary of Results
A questionnaire to measure quality of life (QoL) in cancer patients undergoing chemotherapy had been developed in the 1990 – the EORTC H&N35. It contained 35 questions relating to how the disease itself, and its treatments, affects body functions, most notably breathing, swallowing, and speaking. As these functions are highly relevant, head and neck cancer can cause significant physical, emotional and social problems, reducing quality of life considerably.
However, 20 years later it was considered outdated as it did not cover side effects associated with new treatments. A literature review and patient interviews identified potential new issues which should be included and an updated version of the questionnaire (EORTC H&N45) was tested on 812 head and neck cancer patients from 18 countries. Some patients completed the questionnaire on more than one occasion. One group completed the questionnaire before treatment and again 3 and 6 months later to test for sensitivity (i.e the ability to detect a change in QoL during an unpleasant treatment). Reliability (i.e. the ability to achieve consistent responses when no change in QoL was expected) was tested in a second group of survivors, with two completions only a few days or weeks apart, at least 12 months after their treatment had finished. Other statistical tests assessed validity - that the questions clustered into sensible scales which had been predicted beforehand on the basis of content (e.g. swallowing/eating, problems with speech). Overall, the questionnaire was found to be sensitive, reliable and valid for use in head and neck cancer patients in both clinical trials and clinical practice.
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fonlinelibrary.wiley.com%252Fdoi%252Fabs%252F10.1002%252Fhed.25609%2FNBTI%2FlE_1AQ%2FAQ%2F5b43c3a0-bba7-4e54-a83b-1d1370bc42ad%2F1%2FwFlS40nco3&data=05%7C02%7Csurrey.rec%40hra.nhs.uk%7Ca1f100ed892e4b1d3b9008dc740de0ea%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638512850158026346%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ovUN0%2FXYaV1NvlGBLCGR27n4ENRu04cnxZjhmrZadrA%3D&reserved=0REC name
London - Surrey Research Ethics Committee
REC reference
15/LO/0185
Date of REC Opinion
17 Feb 2015
REC opinion
Favourable Opinion