Oral Assessment of Symptoms in Advanced Cancer (OASis)

May 22, 2020 updated by: Royal Surrey County Hospital NHS Foundation Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

253

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Brighton & Sussex University Hospitals
      • Eastbourne, East Sussex, United Kingdom, BN21 2UD
        • East Sussex Healthcare NHS Trust
    • Kent
      • Margate, Kent, United Kingdom, CT9 4AD
        • Pilgrims Hospice
      • Northfleet, Kent, United Kingdom, DA11 7HQ
        • Ellenor Lions Hospice
      • Pembury, Kent, United Kingdom, TN2 4TA
        • Hospice in the Weald
      • Rochester, Kent, United Kingdom, ME1 2NU
        • Wisdom Hospice
    • Surrey
      • Camberley, Surrey, United Kingdom, GU16 7UJ
        • Frimley Park Hospital
      • Esher, Surrey, United Kingdom, KT10 9RL
        • Princess Alice Hospice
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
    • Wesr Sussex
      • Chichester, Wesr Sussex, United Kingdom, PO18 8QB
        • St. Wilfred's Hospice
    • West Sussex
      • Crawley, West Sussex, United Kingdom, RH10 6BH
        • St. Catherine's Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of oral symptoms (20)
Time Frame: 1 week
Questionnaire
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of physical / psychological symptoms
Time Frame: 1 week
Questionnaire
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2014

Primary Completion (Actual)

July 30, 2015

Study Completion (Actual)

July 30, 2015

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OASis study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Currently, there are no plans to make IPD available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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