Clinical trial NCT04404920: Oral Assessment of Symptoms in Advanced Cancer
Official title: An Observational Study of the Frequency of Oral Symptoms in Patients With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Complication
Cancer
Keywords: Oral symptoms
Cancer
Palliative care
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 subjects that are either inpatients or outpatients at study sites (hospital and hospices in the United Kingdom).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of oral symptoms (20)
timeFrame: 1 week
Secondary outcomes:
measure: Prevalence of physical / psychological symptoms
timeFrame: 1 week
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University Hospitals
state: East Sussex
city: Eastbourne
country: United Kingdom
facility: East Sussex Healthcare NHS Trust
state: East Sussex
city: Margate
country: United Kingdom
facility: Pilgrims Hospice
state: Kent
city: Northfleet
country: United Kingdom
facility: Ellenor Lions Hospice
state: Kent
city: Pembury
country: United Kingdom
facility: Hospice in the Weald
state: Kent
city: Rochester
country: United Kingdom
facility: Wisdom Hospice
state: Kent
city: Camberley
country: United Kingdom
facility: Frimley Park Hospital
state: Surrey
city: Esher
country: United Kingdom
facility: Princess Alice Hospice
state: Surrey
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Chichester
country: United Kingdom
facility: St. Wilfred's Hospice
state: Wesr Sussex
city: Crawley
country: United Kingdom
facility: St. Catherine's Hospice
state: West Sussex
Study officials:
affiliation: Royal Surrey County Hospital NHS Foundation Trust
name: Andrew Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.
citation: Davies A, Buchanan A, Todd J, Gregory A, Batsari KM. Oral symptoms in patients with advanced cancer: an observational study using a novel oral symptom assessment scale. Support Care Cancer. 2021 Aug;29(8):4357-4364. doi: 10.1007/s00520-020-05903-1. Epub 2021 Jan 8.