Adverse Effects, Cancer, Late Effects, Quality of Life, Xerostomia
Conditions
Keywords
EORTC QLQ-C30, Oral health, Quality of life, Questionnaires, Patient reported, outcomes
Brief summary
Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues to improve symptom management has been requested. The present study will be conducted on behalf of and with support from the European Organisation for Research and Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step, in the development of an international, symptom specific questionnaire module, focusing on oral and dental problems in relation to cancer and its treatment. Phase I-III of this stepwise development process was conducted from 2008 to 2011, as an international collaboration and conducted according to the guidelines for module development set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field testing and validation study as described in this project description. The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item scales (pain/discomfort, xerostomia, eating and information) and three single items related to use of dentures and future worries. The aim of the present study is to conduct phase IV; an international field study to confirm the psychometric properties of the QLQ-OH17
Detailed description
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 questionnaires. 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.
Interventions
None listed
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a verified cancer diagnosis other than basal cell carcinoma, incl. H&N cancer * Sufficient language ability to understand and complete the questionnaires without assistance * 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 study
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral morbidity | Up to two years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Up to two years | The questionnaire module that is subject to testing of psychometric properties, will be used together with a well-validated quality of life questionnaire, to investigate if oral morbidity affects overall quality of life |
Countries
France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, Sweden, United Kingdom
Outcome results
None listed