International Validation of the QLQ-OH17 for Oral Health (QLQ-OH17)
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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Leipzig, Deutschland
- University of Leipzig
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Mainz, Deutschland
- Johannes Gutenberg University Mainz
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Metz, Frankreich
- University of Metz
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Athens, Griechenland
- University of Athens
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Tel Aviv, Israel
- Tel-Aviv University
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Naples, Italien
- Istituto Nazionale Tumori "Fondazione G. Pascale"- IRCCS,
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Amsterdam, Niederlande
- VU University Medical Center
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Amsterdam, Niederlande
- Academic Centre for Dentistry Amsterdam
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Oslo, Norwegen
- Oslo University Hospital
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Oslo, Norwegen
- University of Oslo
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Krakow, Polen
- J. Dietl Specialistic Hospital,
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Krakow, Polen
- Jagiellonian University Medical College
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Stockholm, Schweden
- Karolinska University Hospital
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Leeds, Vereinigtes Königreich
- University of Leeds
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Group 1- in active treatment
Questionnaires only
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Group 2 - 2-6 months post-treatment
Questionnaires only
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Group 3 - 6 mos-3yrs post-treatment
Questionnaires only
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Group 4 - Palliative treatment
Questionnaires only
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Group 5 - Referred to dentist/oral team
Questionnaires only
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Oral morbidity
Zeitfenster: Up to two years
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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
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Up to two years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quality of life
Zeitfenster: Up to two years
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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
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Up to two years
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Marianne J Hjermstad, PhD, Oslo University Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2012/1390REK
- EORTC-SG2012 (Andere Zuschuss-/Finanzierungsnummer: EORTC)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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