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NCT04404920 Clinical Trial

Oral Assessment of Symptoms in Advanced Cancer

Cancer Clinical Trial

— OASis  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04404920
Other study ID # OASis study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2014
Est. completion date July 30, 2015

Study information
Verified date May 2020
Source Royal Surrey County Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 253
Est. completion date July 30, 2015
Est. primary completion date July 30, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
United Kingdom Brighton & Sussex University Hospitals Brighton East Sussex
United Kingdom Frimley Park Hospital Camberley Surrey
United Kingdom St. Wilfred's Hospice Chichester Wesr Sussex
United Kingdom St. Catherine's Hospice Crawley West Sussex
United Kingdom East Sussex Healthcare NHS Trust Eastbourne East Sussex
United Kingdom Princess Alice Hospice Esher Surrey
United Kingdom Royal Surrey County Hospital Guildford Surrey
United Kingdom Pilgrims Hospice Margate Kent
United Kingdom Ellenor Lions Hospice Northfleet Kent
United Kingdom Hospice in the Weald Pembury Kent
United Kingdom Wisdom Hospice Rochester Kent

Sponsors (1)
Lead Sponsor Collaborator
Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of oral symptoms (20) Questionnaire 1 week
Secondary Prevalence of physical / psychological symptoms Questionnaire 1 week
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