International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17
The EORTC guidelines will be strictly followed also in phase IV of the module development.
Eligible patients will be contacted by the local study coordinator or a study nurse and
informed about the study. After having provided written informed consent, they will be
presented with the following two questionnaires for self-report of general symptoms,
specific dental and oral symptoms, and quality of life issues; the EORTC QLQ-C30 and the
QLQ-OH17. In addition to these two, a short debriefing interview will be conducted by study
coordinator / study nurse for assessment of feasibility and patients' opinion about the
The case report form (CRF) on medical and demographic data will be completed by the study
coordinator / study nurse before or after the patients have completed their part.
A subset of the patients will be assessed twice, as examination of test - retest reliability
is important in phase IV of the development process.
Observational Model: Cohort, Time Perspective: Cross-Sectional
The study aims to validate a questionnaire for assessment of oral morbidity, oral health , and quality of life in relation to cancer treatment. Specific outcomes are prevalence of patients with moderate to severe oral morbidity due to cancer treatment (mucositis,stomatitis, taste change, decayed /loose teeth, osteoradionecrosis, ulcers), to investigate if the severity varies with certain background variables , for example, diagnostic group, age, sex, stage of disease, type of treatment, and to investigate the discriminant validity, reliability and responsiveness of the specific items in patient subgroups
Up to two years
Marianne J Hjermstad, PhD
Oslo University Hospital
Norway:National Committee for Medical and Health Research Ethics