Oral Symptom Assessment Scale (OSAS): Validity and Reliability

NCT04932317 | Completed

• 1 other identifier: PM202166
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neoplasms

Keywords

Oral health; Oral care; Neoplasms; Palliative care

Outcome Measures

Primary Outcomes (3)

• To measure the reliability of the oral symptom assessment scale (i.e assess if any change)

  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.

  Measured at Time 1 ( Time 1 = 0 hours ) and Time 2 (Time = 24 hours later)

• To measure the concurrent validity of the OSAS against the EORTC QLQ-OH15

  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.

  Measured at Time 1 ( Time = 0 hours)

• To measure ease of use

  Participants will be asked to fill in an ease of use questionnaire at Time point 1. The two questions will be yes or no answers ( 1. Did you think the OSAS was easy to complete? 2. Did you think the EORTC QLQ C30 and EORTC QLQ OH15 was easy to complete?)

  Measured at Time 1 ( Time = 0 hours)

Other Outcomes (1)

• Ease of answering questionnaire

  At Time 1 only ( Time 1 = 0 hours)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced cancer admitted to a specialist palliative care in-patient unit

You may qualify if:

• Any cancer diagnosis
• Age ≥ 18 years old
• Able to understand and speak English
• Signed witnessed consent form
• In the 'Stable' clinical phase

You may not qualify if:

• 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

Sponsors & Collaborators

• Our Lady's Hospice and Care Services: lead
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Our Lady's Hospice and Care Services

Dublin, Ireland

Location

Related Publications (12)

• Glick 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 BACKGROUND

• 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.

  PMID: 22572480 BACKGROUND

• Davies, 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

  BACKGROUND

• Davies 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 BACKGROUND

• Shah 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 BACKGROUND

• Aktas 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 BACKGROUND

• 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.

  PMID: 27113466 BACKGROUND

• Paiva CE, Barroso EM, Carneseca EC, de Padua Souza C, Dos Santos FT, Mendoza Lopez RV, Ribeiro Paiva SB. A critical analysis of test-retest reliability in instrument validation studies of cancer patients under palliative care: a systematic review. BMC Med Res Methodol. 2014 Jan 21;14:8. doi: 10.1186/1471-2288-14-8.

  PMID: 24447633 BACKGROUND

• Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

  PMID: 7165009 BACKGROUND

• Smith, M . Palliative care casemix - stage 2 development: a national classification for any site of care. 8th national casemix conference, Sydney, NSW, Australia, 16-18 September 1996. Canberra, ACT, Australia: Commonwealth Department of Human Services and Health.

  BACKGROUND

• Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.

  PMID: 27330520 BACKGROUND

• Arifin, W.N. 2018. A Web-based Sample Size Calculator for Reliability Studies. Educational Resources. https://pdfs.semanticscholar.org/0bf5/ddcc23d91a941fa0bacf992de1f970e33a1c.pdf

  BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Andrew Davies, MB FRCP

  Our Lady's Hospice, Harold's Cross, Dublin 6W Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Palliative Medicine

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: June 21, 2021
• Study Start: August 5, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)