Clinical trial · Observational
Oral Symptom Assessment Scale (OSAS): Validity and Reliability
NCT04932317CI-TRIAL-00065195completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oral (mouth) symptoms are very common and often bothersome in patients with cancer. The best way to assess these symptoms is using a patient-rated symptom assessment scale. A new symptom assessment scale for oral symptoms has been developed and already tested in patients. The purpose of this study is to test the scale again to make sure it is reliable and accurate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To measure the reliability of the oral symptom assessment scale (i.e assess if any change)
- timeFrame
- Measured at Time 1 ( Time 1 = 0 hours ) and Time 2 (Time = 24 hours later)
- description
- The oral symptom assessment scale is a twenty-question patient-reported symptom assessment scale. Participants are asked to rate how often ( rarely, occasionally, frequently, almost constantly), the severity (slight, moderate, severe, very severe) and distress or bother ( not at all, a little bit, somewhat, quite a bit, very much) of any of these twenty oral symptoms during the past week.
- measure
- To measure the concurrent validity of the OSAS against the EORTC QLQ-OH15
- timeFrame
- Measured at Time 1 ( Time = 0 hours)
- description
- The European Organisation for Research and Treatment of Cancer Quality of Life of cancer patients questionnaire is a patient-reported outcomes evaluation of quality of life in cancer patients and the European Organisation of Research and Treatment of Cancer Quality of Life Oral Health questionnaire is an oral health quality of life module. The former consists of thirty questions assessing five functions, nine symptoms and global health status/quality of life. The EORTC QLQ OH-15 module consists of one multi-item scale to assess oral health quality of life and five single items to assess sore mouth, sticky saliva, sensitivity, dentures and information.All of the scales and single-item measures range in score from 0 to 100.A high score for the functional scale and single item represents a high level of functioning, this is, a low level of symptomatology or problems. A high score for the symptom items represents a high level of symptomatology or problems.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Any cancer diagnosis * Age ≥ 18 years old * Able to understand and speak English * Signed witnessed consent form * In the 'Stable' clinical phase Exclusion Criteria * In the judgement of the Palliative Care physician, study participation is not appropriate * Unable to complete the study assessments in entirety i.e. in full at Time 1 ( 0 hours) and at Time 2 (24 hours later) * In the 'Unstable', 'Deteriorating' or 'Terminal' clinical phase
References
Publications (12)
- BACKGROUNDGlick M, Williams DM, Kleinman DV, Vujicic M, Watt RG, Weyant RJ. A new definition for oral health developed by the FDI World Dental Federation opens the door to a universal definition of oral health. J Am Dent Assoc. 2016 Dec;147(12):915-917. doi: 10.1016/j.adaj.2016.10.001. No abstract available. PMID 27886668
- BACKGROUNDHjermstad 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. PMID 22572480
- BACKGROUNDDavies, A. 2010. Oral care in advanced cancer patients. In: Davies A.N. and Epstein J.B. (eds) Oral Complications of Cancer and Its Management. Oxford University Press, Oxford, pp279-289
- BACKGROUNDDavies A, Buchanan A, Todd J, Gregory A, Batsari KM. Oral symptoms in patients with advanced cancer: an observational study using a novel oral symptom assessment scale. Support Care Cancer. 2021 Aug;29(8):4357-4364. doi: 10.1007/s00520-020-05903-1. Epub 2021 Jan 8. PMID 33416995
- BACKGROUNDShah S, Davies AN. Re: medical records vs. patient self-rating. J Pain Symptom Manage. 2001 Oct;22(4):805-6. doi: 10.1016/s0885-3924(01)00348-7. No abstract available. PMID 11596613
- BACKGROUNDAktas A, Walsh D, Kirkova J. The psychometric properties of cancer multisymptom assessment instruments: a clinical review. Support Care Cancer. 2015 Jul;23(7):2189-202. doi: 10.1007/s00520-015-2732-7. Epub 2015 Apr 19. PMID 25894883
- BACKGROUNDHjermstad 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.