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Completed

NCT Number: NCT04404920

Oral Assessment of Symptoms in Advanced Cancer

Observational study of prevalence of oral symptoms in patients with advanced cancer using a novel questionnaire ("Oral symptom assessment scale")

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brighton & Sussex University Hospitals, Brighton, East Sussex, United Kingdom

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About this study

A novel questionnaire (the "Oral symptom assessment scale" / OSAS) has been developed to assess a range of oral symptoms in patients with advanced cancer.

The OSAS consists of 20 symptoms, which were chosen following a review of the literature / discussion with experts in the field. The OSAS was modelled on the Memorial Symptom Assessment Scale (MSAS), and asks about the presence of the symptoms, the frequency of the symptoms (i.e. "rarely"; "occasionally"; "frequently"; or "almost constantly"), the severity of the symptoms (i.e. "slight"; "moderate"; "severe"; or "very severe"), and how much distress they cause (i.e. "not at all"; "a little bit"; "somewhat"; "quite a bit"; or "very much"). The questions relate to the last week.

Patients will be given the OSAS to complete, and also the short form of the MSAS (which asks about the presence, and related distress, of 32 physical / psychological symptoms, including a small number of oral symptoms). Demographic data, cancer diagnosis, and performance status will also be collected. The study involves a single visit / assessment.

Descriptive statistics will be used to present the data, and hierarchical cluster analysis will be used to identify oral symptom clusters. Kappa tests will be used to compare analogous questions on the OSAS and short form MSAS (as part of the validation of the OSAS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age > 18yr; diagnosis of locally advanced / metastatic cancer; already known to the specialist palliative care team

Exclusion criteria

  • inability to give informed consent; inability to complete questionnaires

Treatment and study plan

Questionnaire

Other

Novel questionnaire about oral symptoms ("Oral symptom assessment scale / OSAS), and validated questionnaire about physical and psychological symptoms (Memorial Symptom Assessment Scale / MSAS).

Primary outcomes

  1. Prevalence of oral symptoms (20)

    Time frame: 1 week

    Questionnaire

Secondary outcomes

  1. Prevalence of physical / psychological symptoms

    Time frame: 1 week

    Questionnaire

Sponsors and collaborators

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Other

Registry information

Official study title

An Observational Study of the Frequency of Oral Symptoms in Patients With Advanced Cancer

Acronym: OASis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 28, 2020
Registry last updated
May 28, 2020

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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