International Validation of the QLQ-OH17 for Oral Health (QLQ-OH17)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724333
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : April 29, 2016
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Oslo University Hospital

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

Condition or disease
Quality of Life Adverse Effects Late Effects Cancer Xerostomia

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.

Study Type : Observational
Actual Enrollment : 585 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17
Study Start Date : December 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Group 1- in active treatment
Questionnaires only
Group 2 - 2-6 months post-treatment
Questionnaires only
Group 3 - 6 mos-3yrs post-treatment
Questionnaires only
Group 4 - Palliative treatment
Questionnaires only
Group 5 - Referred to dentist/oral team
Questionnaires only

Primary Outcome Measures :
  1. Oral morbidity [ Time Frame: 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 Outcome Measures :
  1. Quality of life [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
An international, cross-cultural sample of cancer patients with different diagnoses in different phases of treatment

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01724333

University of Metz
Metz, France
University of Leipzig
Leipzig, Germany
Johannes Gutenberg University Mainz
Mainz, Germany
University of Athens
Athens, Greece
Tel-Aviv University
Tel Aviv, Israel
Istituto Nazionale Tumori "Fondazione G. Pascale"- IRCCS,
Naples, Italy
Academic Centre for Dentistry Amsterdam
Amsterdam, Netherlands
VU University Medical Center
Amsterdam, Netherlands
Oslo University Hospital
Oslo, Norway
University of Oslo
Oslo, Norway
J. Dietl Specialistic Hospital,
Krakow, Poland
Jagiellonian University Medical College
Krakow, Poland
Karolinska University Hospital
Stockholm, Sweden
United Kingdom
University of Leeds
Leeds, United Kingdom
Sponsors and Collaborators
Oslo University Hospital
European Organisation for Research and Treatment of Cancer - EORTC
Principal Investigator: Marianne J Hjermstad, PhD Oslo University Hospital

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Oslo University Hospital Identifier: NCT01724333     History of Changes
Other Study ID Numbers: 2012/1390REK
EORTC-SG2012 ( Other Grant/Funding Number: EORTC )
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: November 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Phase III and Phase IV reports approved by the EORTC Quality of Life Group Executive Committee. First publication in Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Second publication accepted for publication in Supp Care Cancer, April 2016

Keywords provided by Oslo University Hospital:
Oral health
Quality of life
Patient reported

Additional relevant MeSH terms:
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases