NCT04404920

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2015

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 22, 2020

Last Update Submit

May 22, 2020

Conditions

Keywords

Oral symptomsCancerPalliative care

Outcome Measures

Primary Outcomes (1)

  • Prevalence of oral symptoms (20)

    Questionnaire

    1 week

Secondary Outcomes (1)

  • Prevalence of physical / psychological symptoms

    1 week

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

250 subjects that are either inpatients or outpatients at study sites (hospital and hospices in the United Kingdom).

You may qualify if:

  • age \> 18yr; diagnosis of locally advanced / metastatic cancer; already known to the specialist palliative care team

You may not qualify if:

  • inability to give informed consent; inability to complete questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Brighton & Sussex University Hospitals

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

East Sussex Healthcare NHS Trust

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

Pilgrims Hospice

Margate, Kent, CT9 4AD, United Kingdom

Location

Ellenor Lions Hospice

Northfleet, Kent, DA11 7HQ, United Kingdom

Location

Hospice in the Weald

Pembury, Kent, TN2 4TA, United Kingdom

Location

Wisdom Hospice

Rochester, Kent, ME1 2NU, United Kingdom

Location

Frimley Park Hospital

Camberley, Surrey, GU16 7UJ, United Kingdom

Location

Princess Alice Hospice

Esher, Surrey, KT10 9RL, United Kingdom

Location

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

St. Wilfred's Hospice

Chichester, Wesr Sussex, PO18 8QB, United Kingdom

Location

St. Catherine's Hospice

Crawley, West Sussex, RH10 6BH, United Kingdom

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Andrew Davies, MD

    Royal Surrey County Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 28, 2020

Study Start

September 3, 2014

Primary Completion

July 30, 2015

Study Completion

July 30, 2015

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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

Locations