NCT04404920

Oral Assessment of Symptoms in Advanced Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 253 (actual)
• Sponsor: Royal Surrey County Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Oral Complication
• Cancer

Interventions

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

Timeline

• Start date: 2014-09-03
• Primary completion: 2015-07-30
• Completion: 2015-07-30
• First posted: 2020-05-28
• Last updated: 2020-05-28

Locations

11 sites across 1 country: United Kingdom