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临床试验/NCT04749589
NCT04749589已完成不适用

Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy

Esbjerg Hospital - University Hospital of Southern Denmark2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年2月11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
200
试验地点
2
主要终点
Fatigue

研究概览

简要总结

The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.

详细描述

Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available.

The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • patients in whom endoscopy has raised suspicion of colorectal malignancy

排除标准

  • non fluent in Danish language
  • cerebral impairment (ex severe dementia) so that informed consent can not be obtained

结局指标

主要结局

Fatigue

时间窗: up to one months after inclusion

Fatigue sub-scale of Focussed assessment of cancer treatment - anemia

次要结局

  • peripheral muscular strengths(up to one months after inclusion)
  • mobility and balance(up to one months after inclusion)
  • endurance(up to one months after inclusion)
  • Quality of life(up to one months after inclusion)
  • Cognitive ability(up to one months after inclusion)

研究者

发起方
Esbjerg Hospital - University Hospital of Southern Denmark
申办方类型
Other
责任方
Sponsor

研究点 (2)

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