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International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17

18 Years
Not Enrolling
Quality of Life, EORTC, Oral Health

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Trial Information

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.

Inclusion Criteria

Inclusion Criteria

- Patients with a verified cancer diagnosis other than basal cell carcinoma, incl. H&N

- Sufficient language ability to understand and complete the questionnaires without

- No obvious cognitive impairments, as judged by the study coordinator upon inclusion

- Age 18 years or above

- Provision of written informed consent

- No participation in another trial or study possibly interfering with the present

Exclusion Criteria:

- Patients being diagnosed with basal cell carcinoma

- Patients who have been included in Phase I-III of the module development

- Patients who are in the terminal phase of cancer

- Patients who are unable to participate in the interviews do to obvious cognitive
impairment, psychological disturbance or language problems

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Oral morbidity

Outcome Description:

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

Outcome Time Frame:

Up to two years

Safety Issue:


Principal Investigator

Marianne J Hjermstad, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital


Norway:National Committee for Medical and Health Research Ethics

Study ID:




Start Date:

December 2012

Completion Date:

December 2015

Related Keywords:

  • Quality of Life
  • Oral Health
  • Oral health
  • Quality of life
  • Questionnaires
  • Patient reported
  • outcomes