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临床试验/NCT04404920
NCT04404920已完成不适用

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

Royal Surrey County Hospital NHS Foundation Trust11 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2014年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
253
试验地点
11
主要终点
Prevalence of oral symptoms (20)

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • inability to give informed consent; inability to complete questionnaires

结局指标

主要结局

Prevalence of oral symptoms (20)

时间窗: 1 week

Questionnaire

次要结局

  • Prevalence of physical / psychological symptoms(1 week)

研究者

发起方
Royal Surrey County Hospital NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (11)

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