Oral Symptom Assessment Scale (OSAS): Validity and Reliability

March 30, 2023 updated by: Prof Andrew Davies, Our Lady's Hospice and Care Services
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.

Study Overview

Status

Completed

Conditions

Detailed 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 Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Niamh Cleary, MB MICGP
  • Phone Number: +353 87 6603466
  • Email: clearynm@tcd.ie

Study Contact Backup

  • Name: Andrew Davies, MB FRCP
  • Phone Number: + 353 1 406 8700
  • Email: adavies@olh.ie

Study Locations

  • Ireland
      • Dublin, Ireland
        • Our Lady's Hospice and Care Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the reliability of the oral symptom assessment scale (i.e assess if any change)
Time Frame: Measured at Time 1 ( Time 1 = 0 hours ) and Time 2 (Time = 24 hours later)
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
Time Frame: Measured at Time 1 ( Time = 0 hours)
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
Time Frame: Measured at Time 1 ( Time = 0 hours)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of answering questionnaire
Time Frame: At Time 1 only ( Time 1 = 0 hours)
Participants will be asked about how easy the questionnaires are to answer i.e the two questions posed are : "Did you think Questionnaire 1 (OSAS) was easy to complete?" Answer: Yes or No and " Did you think Questionnaire 2 (EORTC QLQ-C30 and EORTC QLQ-OH15) was easy to complete?" Answer: Yes or No
At Time 1 only ( Time 1 = 0 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Our Lady's Hospice and Care Services

Collaborators

University of Dublin, Trinity College

Investigators

  • Principal Investigator: Andrew Davies, MB FRCP, Our Lady's Hospice, Harold's Cross, Dublin 6W Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2021

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM202166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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