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Oral Assessment of Symptoms in Advanced Cancer (OASis)

R

Royal Surrey County Hospital NHS Foundation Trust

Status

Completed

Conditions

Oral Complication
Cancer

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04404920
OASis study

Details and patient eligibility

About

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

Full description

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).

Enrollment

253 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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