Clinical trial NCT01724333: International Validation of the QLQ-OH17 for Oral Health
Official title: International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Adverse Effects
Late Effects
Cancer
Xerostomia
Keywords: EORTC QLQ-C30
Oral health
Quality of life
Questionnaires
Patient reported
outcomes
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2012-11-09
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: An international, cross-cultural sample of cancer patients with different diagnoses in different phases of treatment

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.

Eligibility 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

Primary outcomes:
measure: Oral morbidity
timeFrame: Up to two years
Secondary outcomes:
measure: Quality of life
timeFrame: Up to two years
Other outcomes:
Locations:
city: Metz
country: France
facility: University of Metz
city: Leipzig
country: Germany
facility: University of Leipzig
city: Mainz
country: Germany
facility: Johannes Gutenberg University Mainz
city: Athens
country: Greece
facility: University of Athens
city: Tel Aviv
country: Israel
facility: Tel-Aviv University
city: Naples
country: Italy
facility: Istituto Nazionale Tumori "Fondazione G. Pascale"- IRCCS,
city: Amsterdam
country: Netherlands
facility: Academic Centre for Dentistry Amsterdam
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: University of Oslo
city: Krakow
country: Poland
facility: J. Dietl Specialistic Hospital,
city: Krakow
country: Poland
facility: Jagiellonian University Medical College
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
affiliation: Oslo University Hospital
name: Marianne J Hjermstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 of life in cancer patients. Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Epub 2012 May 8.
citation: Johns SA, Brown LF, Beck-Coon K, Talib TL, Monahan PO, Giesler RB, Tong Y, Wilhelm L, Carpenter JS, Von Ah D, Wagner CD, de Groot M, Schmidt K, Monceski D, Danh M, Alyea JM, Miller KD, Kroenke K. Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors. Support Care Cancer. 2016 Oct;24(10):4085-96. doi: 10.1007/s00520-016-3220-4. Epub 2016 May 17.