International Validation of the QLQ-OH17 for Oral Health

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Oslo University Hospital
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01724333
First received: November 2, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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
Quality of Life
EORTC
Oral Health

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Oral morbidity [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 530
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1a - in active treatment
Questionnaires only
Group 1b - 2-6 months post-treatment
Questionnaires only
Group 1C - 6 mos-3yrs post-treatment
Questionnaires only
Group 1D - Palliative treatment
Questionnaires only
Group 1D- Referred to dentist/oral team
Questionnaires only

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724333

Contacts
Contact: Marianne J Hjermstad, PhD 4723026828 m.j.hjermstad@medisin.uio.no
Contact: Nina Aaass, PhD 4723026828 NAA@ous-hf.no

Locations
Australia
University of Adelaide Not yet recruiting
Adelaide, Australia
Contact: Richard Logan, PhD       richard.logan@adelaide.edu.au   
France
University of Metz Not yet recruiting
Metz, France
Contact: Sebastien Montel, PhD       montel@univ-metz.fr   
Germany
University of Freiburg Not yet recruiting
Freiburg, Germany
Contact: Joachim Weis, PhD       weis@tumorbio.uni-freiburg.de   
University of Leipzig Not yet recruiting
Leipzig, Germany
Contact: Dirk Hofmeister, PhD       Dirk.Hofmeister@medizin.uni-leipzig.de   
Johannes Gutenberg University Mainz Not yet recruiting
Mainz, Germany
Contact: Susanne Singer, PhD       mailto:singer@imbei.uni-mainz.de   
Greece
University of Athens Not yet recruiting
Athens, Greece
Contact: Ourania Nicolatou-Galitis, PhD       nicolatou.galitis@lycos.com   
Israel
Tel-Aviv University Not yet recruiting
Tel Aviv, Israel
Contact: Noam Yarom, PhD       noamyar@post.tau.ac.il   
Netherlands
VU University Medical Center Not yet recruiting
Amsterdam, Netherlands
Contact: Irma Verdonck-de Leeuw, PhD       IM.Verdonck@vumc.nl   
Academic Centre for Dentistry Amsterdam Not yet recruiting
Amsterdam, Netherlands
Contact: Judith Raber-Durlacher, PhD       jraber@worldonline.nl   
Sweden
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Contact: Mia Bergenmar, PhD       Mia.Bergenmar@ki.se   
United Kingdom
University of Leeds Not yet recruiting
Leeds, United Kingdom
Contact: Sheila Fisher, PhD       S.E.Fisher@doctors.org.uk   
Sponsors and Collaborators
Oslo University Hospital
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Principal Investigator: Marianne J Hjermstad, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01724333     History of Changes
Other Study ID Numbers: 2012/1390REK, EORTC-SG2012
Study First Received: November 2, 2012
Last Updated: November 6, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
EORTC QLQ-C30
Oral health
Quality of life
Questionnaires
Patient reported
outcomes

ClinicalTrials.gov processed this record on September 30, 2014