EORTC QL Questionnaire Development Phases I/II - Thyroid Cancer
Research type
Research Study
Full title
Development of an EORTC questionnaire for the assessment of quality of life in thyroid cancer patients (EORTC QLQ-THY) Phase I/II & Phase III
IRAS ID
136596
Contact name
Teresa Young
Contact email
Sponsor organisation
East & North Hertfordshire NHS Trust
Research summary
Summary of Results
The objective of this study was to pilot-test a questionnaire measuring quality of life (QoL) in thyroid cancer patients to be used in conjunction with the European Organisation for Research and Treatment of Cancer (EORTC) quality of life core questionnaire EORTC QLQ-C30. A provisional questionnaire with 47 items was administered to thyroid cancer patients.Patients were eligible for this study if they had been treated for thyroid cancer within the last 2 years. After completing the questionnaire, patients were interviewed about time and help needed to complete it, and whether they found the items understandable, confusing, or irritating. They also indicated whether the items were relevant to them or not. The percentage of missing answers per item was calculated to assess compliance with the questionnaire.
Items were kept in the questionnaire if they fulfilled pre-defined criteria: if they were relevant to the patients, easy to understand, not confusing, and if they had few missing values, neither floor nor ceiling effects, and high variance. Patients could indicate whether an issue concerning their QoL was missing. If ≥ 5 patients mentioned the same issue as missing, it was added to the questionnaire. A total of 182 thyroid cancer patients in 15 countries participated (n=115 with papillary, n=31 with follicular, n=22 with medullary, n=6 with anaplastic, and n=8 with other thyroid cancer). 66% of the patients needed 15 minutes or less to complete the questionnaire. 60% required no help for completing.
Of the 47 items, 31 fulfilled the criteria and were kept unchanged, 14 were removed, 2 were changed. Shoulder dysfunction was mentioned by 5 patients as missing, therefore an item covering this issue was added. The EORTC quality of life module for thyroid cancer consisting of 34 items is now pilot-tested and ready for the final validation phase IV. From now on, it can be used in academic studies upon request from the EORTC.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
13/LO/1237
Date of REC Opinion
17 Oct 2013
REC opinion
Further Information Favourable Opinion