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临床试验/NCT01317355
NCT01317355已完成不适用

Prevalence of Multiple Symptoms in Cancer Patients a Cross Sectional Prospective Multi Center Study

Martin-Luther-Universität Halle-Wittenberg1 个研究点 分布在 1 个国家目标入组 697 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
697
试验地点
1
主要终点
Symptom burden (intensity & functional impairment) (MDASI)

研究概览

简要总结

This study will assess the occurrence of multiple symptoms in cancer patients of 5 German university hospitals. Primary goal of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder).

详细描述

Oncology patients experience a variety of symptoms as a result of disease and/or treatment. They often report co-occurrence of symptoms and functional impairments (Miaskowski 2007). To evaluate the prevalence of symptoms and identify symptom clusters and the influence of multiple symptoms on HRQoL, in and out patients of 5 German university hospitals currently undergoing cancer treatment are recruited. These patients are asked to complete the following instruments: Distress thermometer, health related quality of life questionnaire (EORTC QLQ C30) and MD. Anderson Symptom Inventory (MDASI (German version). In a subgroup of two participating hospitals patients, that score ≥ 3/10 (MDASI-subscales for pain, fatigue and/or sleep disorder) are asked to complete additional questionnaires: Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI), Pittsburgh Sleep Quality Index (PSQI). The information gained will not be accessible for doctors in charge of the treatment and therefore not influence or alter the participants' treatment regimes.

Primary endpoint of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder). Secondary endpoints are: symptom burden (intensity of symptoms and functional impairments), impact of symptom burden on HRQoL.

The investigators aim to approve the value of standardized assessment of symptoms in clinical cancer care settings as an important precondition of early treatment and supportive care.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cancer patients (ICD 10)
  • 18 to 80 years of age
  • ongoing treatment
  • informed consent

排除标准

  • not speaking and writing German

结局指标

主要结局

Symptom burden (intensity & functional impairment) (MDASI)

时间窗: 24 hours

次要结局

  • Distress thermometer(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Jahn

Dr. rer. medic. Patrick Jahn

Martin-Luther-Universität Halle-Wittenberg

研究点 (1)

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