International Validation of the QLQ-OH17 for Oral Health

Cancer Clinical Trial

— QLQ-OH17  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724333
• Other study ID #: 2012/1390REK
• Secondary ID: EORTC-SG2012
• Status: Completed
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: December 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effects
• Cancer
• Late Effects
• Quality of Life
• Xerostomia

Locations

Country	Name	City	State
France	University of Metz	Metz
Germany	University of Leipzig	Leipzig
Germany	Johannes Gutenberg University Mainz	Mainz
Greece	University of Athens	Athens
Israel	Tel-Aviv University	Tel Aviv
Italy	Istituto Nazionale Tumori "Fondazione G. Pascale"- IRCCS,	Naples
Netherlands	Academic Centre for Dentistry Amsterdam	Amsterdam
Netherlands	VU University Medical Center	Amsterdam
Norway	Oslo University Hospital	Oslo
Norway	University of Oslo	Oslo
Poland	J. Dietl Specialistic Hospital,	Krakow
Poland	Jagiellonian University Medical College	Krakow
Sweden	Karolinska University Hospital	Stockholm
United Kingdom	University of Leeds	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Sweden,  United Kingdom, 

References & Publications (2)

Hjermstad MJ, Bergenmar M, Bjordal K, Fisher SE, Hofmeister D, Montel S, Nicolatou-Galitis O, Pinto M, Raber-Durlacher J, Singer S, Tomaszewska IM, Tomaszewski KA, Verdonck-de Leeuw I, Yarom N, Winstanley JB, Herlofson BB; EORTC QoL Group. International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15. Support Care Cancer. 2016 Sep;24(9):3915-24. doi: 10.1007/s00520-016-3216-0. Epub 2016 Apr 25. — View Citation

Hjermstad MJ, Bergenmar M, Fisher SE, Montel S, Nicolatou-Galitis O, Raber-Durlacher J, Singer S, Verdonck-de Leeuw I, Weis J, Yarom N, Herlofson BB. The EORTC QLQ-OH17: a supplementary module to the EORTC QLQ-C30 for assessment of oral health and quality — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral morbidity	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
Secondary	Quality of life	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	Up to two years