Oral Assessment of Symptoms in Advanced Cancer

Completed

• Conditions: Cancer; Oral Complication

• Registration Number: NCT04404920
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief 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).

Study Timeline

• Study Start: 2014-09-03
• Primary Completion: 2015-07-30
• Study Completion: 2015-07-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Last Update Submitted: 2020-05-22
• Study First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of oral symptoms (20)	1 week	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Prevalence of physical / psychological symptoms	1 week	Questionnaire

Trial Locations

Locations (11)

Hospice in the Weald; 🇬🇧 Pembury, Kent, United Kingdom

St. Wilfred's Hospice; 🇬🇧 Chichester, Wesr Sussex, United Kingdom

Ellenor Lions Hospice; 🇬🇧 Northfleet, Kent, United Kingdom

Pilgrims Hospice; 🇬🇧 Margate, Kent, United Kingdom

Wisdom Hospice; 🇬🇧 Rochester, Kent, United Kingdom

Brighton & Sussex University Hospitals; 🇬🇧 Brighton, East Sussex, United Kingdom

East Sussex Healthcare NHS Trust; 🇬🇧 Eastbourne, East Sussex, United Kingdom

Royal Surrey County Hospital; 🇬🇧 Guildford, Surrey, United Kingdom

St. Catherine's Hospice; 🇬🇧 Crawley, West Sussex, United Kingdom

Frimley Park Hospital; 🇬🇧 Camberley, Surrey, United Kingdom

Princess Alice Hospice; 🇬🇧 Esher, Surrey, United Kingdom