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Completed

NCT Number: NCT04932317

Oral Symptom Assessment Scale (OSAS): Validity and Reliability

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Our Lady's Hospice and Care Services

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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?)

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Our Lady's Hospice and Care Services

Other

Collaborators

  • University of Dublin, Trinity College

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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