- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01724333
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Leipzig, Allemagne
- University of Leipzig
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Mainz, Allemagne
- Johannes Gutenberg University Mainz
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Metz, France
- University of Metz
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Athens, Grèce
- University of Athens
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Tel Aviv, Israël
- Tel-Aviv University
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Naples, Italie
- Istituto Nazionale Tumori "Fondazione G. Pascale"- IRCCS,
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Oslo, Norvège
- Oslo University Hospital
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Oslo, Norvège
- University of Oslo
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Amsterdam, Pays-Bas
- VU University Medical Center
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Amsterdam, Pays-Bas
- Academic Centre for Dentistry Amsterdam
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Krakow, Pologne
- J. Dietl Specialistic Hospital,
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Krakow, Pologne
- Jagiellonian University Medical College
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Leeds, Royaume-Uni
- University of Leeds
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Stockholm, Suède
- Karolinska University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Oral morbidity
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Quality of life
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marianne J Hjermstad, PhD, Oslo University Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2012/1390REK
- EORTC-SG2012 (Autre subvention/numéro de financement: EORTC)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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Essais cliniques sur Qualité de vie
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Queens College, The City University of New YorkRecrutementPublication d'articles soumis à l'American Journal of Public HealthÉtats-Unis
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Abramson Cancer Center of the University of PennsylvaniaRetiréPatients cancéreux subissant une greffe de cellules souches (RCT of ACP for Transplant)
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Swansea UniversityComplétéA Bite of ACT '(BOA) Cours de psychoéducation en ligne sur la thérapie d'acceptation et d'engagement | Un contrôle de liste d'attenteRoyaume-Uni
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Yale-NUS CollegeComplétéL'objectif de l'étude est les réponses des patients à un questionnaire de gestion de l'obésité administré par le SGH Life CenterSingapour
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Central Hospital, Nancy, FranceInstitut National de la Santé Et de la Recherche Médicale, FranceComplétéInflammation | Maladies du système nerveux autonome | Choc, cardiogénique | Extra-Corporeal-Life-Support (ECLS)France
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Yale-NUS CollegeComplétéL'objectif de l'étude est les réponses des patients à un questionnaire de gestion de l'obésité administré par le SGH Life CenterSingapour