Developing a CTCAEs patient questionnaire for late toxicity after head and neck radiotherapy.
OBJECTIVE
Patient-based reporting of symptoms is increasingly important in providing treatment toxicity information. However, observer-based scoring systems such as the CTCAEs which incorporate the LENT-SOMA scales are not adapted for patient-based reporting. We aim to (1) report the late toxicity in patients following head and neck radiotherapy using a LENT-SOMA patient-based questionnaire, (2) describe how the responses help to improve the questionnaire and (3) adapt the questionnaire for patient reporting using CTCAEs.


METHODS
A 31-item LENT-SOMA patient questionnaire was administered prospectively to 220 patients pre-treatment and at eight time periods post-radical head and neck radiotherapy over 3 years. Exploratory factor analysis was carried out and questionnaire reliability was evaluated using Cronbach's alpha coefficient.


RESULTS
At 3-years follow-up, grade 3/4 toxicity was recorded for xerostomia (44%), hoarseness (14.3%), altered taste (6.1%) and oropharyngeal pain (1.9%). Factor analysis indicated that questionnaire division according to anatomical sub-site was reasonable. Cronbach's alpha was 0.851 (95% CI: 0.820-0.883) indicating high reliability. Good compliance was obtained with all questions except for the 'weight loss' item. A satisfaction survey showed that the questionnaire was clear and concise. Teeth and mandible sections have been removed. Dietary change due to xerostomia has been incorporated in line with CTCAEs. LENT-SOMA scoring of analgesic needs and dysphagia not described in CTCAEs were found useful and have been retained.


CONCLUSIONS
The questionnaire has enabled reporting of late toxicity and the responses have enabled refinement of the questionnaire. It is reliable, feasible and has been validated for patient-based collection of CTCAEs late toxicity data.
Ho
K F
KF
Academic Radiation Oncology, University of Manchester, The Christie NHS Foundation Trust, Manchester, United Kingdom. kean.ho@manchester.ac.uk
Farnell
D J J
DJ
Routledge
J A
JA
Burns
M P
MP
Sykes
A J
AJ
Slevin
N J
NJ
Davidson
S E
SE
D003680:Deglutition Disorders / Q000209:etiology; D005260:Female; D005355:Fibrosis; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D009960:Oropharynx; D010146:Pain / Q000209:etiology; D025341:Principal Component Analysis; D011446:Prospective Studies; D011594:Psychometrics; D012867:Skin / Q000473:pathology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014313:Trismus / Q000209:etiology; D014987:Xerostomia / Q000209:etiology