Oral Symptom Assessment Scale (OSAS): Validity & Reliability

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Neoplasms

Clinical Trial Details

NCT number	NCT04932317
Study type	Observational
Source	Our Lady's Hospice and Care Services
Contact
Status	Completed
Phase
Start date	August 5, 2021
Completion date	August 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Oral Symptom Assessment Scale (OSAS): Validity and Reliability

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms