Oral Symptom Assessment Scale (OSAS): Validity and Reliability

  • STATUS
    Recruiting
  • days left to enroll
    12
  • participants needed
    64
  • sponsor
    Our Lady's Hospice and Care Services
Updated on 12 May 2022
cancer diagnosis
primary cancer

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.

Description

Oral health is multifaceted and includes an individual's ability to speak, eat as well as to convey emotion without pain, embarrassment or discomfort. Oral health contributes to an individual's general well-being.

Poor oral health in patients with advanced cancer can be associated with negative impacts on an individual's quality of life in terms of psychological and emotional distress (e.g. avoiding social interactions due to embarrassment) and physical distress (e.g. pain associated with mucositis). As well as this certain problems can be associated indirectly with mortality in patients with advanced cancer e.g. oral infection leading to systemic infection.

In patients with advanced cancer oral symptoms are common, often multiple and of high-impact. Routine screening for oral symptoms should be undertaken in all patients with advanced cancer in conjunction with regular examination of the oral cavity to ensure correct diagnosis and adequate treatment.

A novel oral symptom assessment scale (OSAS) was designed and developed to measure the frequency, severity and distress (or bother) of twenty oral symptoms in patients with advanced cancer. This initial observational study provided provisional validation of the new assessment tool.

This study aims to further investigate the reliability and validity of this novel oral symptom assessment tool in patients with advanced cancer. Test-retesting will occur in patients deemed clinically stable. Test- retesting will be undertaken to measure reliability on two occasions 24-48 hours apart. Recruited patients will be asked to fill in the OSAS as well as the EORTC QLQ- C30 and EORTC QLQ-OH15 (a validated quality of life assessment with an oral health module) which will provide criterion (concurrent) validity.

Details
Condition Neoplasms
Clinical Study IdentifierNCT04932317
SponsorOur Lady's Hospice and Care Services
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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