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

April 28, 2016 updated by: Oslo University Hospital

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

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

An international, cross-cultural sample of cancer patients with different diagnoses in different phases of treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Marianne J Hjermstad, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 9, 2012

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1390REK
  • EORTC-SG2012 (Other Grant/Funding Number: EORTC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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