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临床试验/NCT04443816
NCT04443816已完成不适用

Advanced Geriatric Evaluation in Predicting Health Related Quality of Life in Patients With Colorectal Cancer

St. Antonius Hospital6 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
273
试验地点
6
主要终点
Loss of health related quality of life (HRQL)

研究概览

简要总结

Colorectal cancer (CRC) disproportionately affects patients aged 70 years and older. Surgery is the main treatment modality for CRC, but is associated with increased risk of postoperative morbidity, disability and loss of health related quality of life (HRQL).Frailty is an age related state of functional decline and considered to be an important risk factor for adverse outcome in geriatric oncology.Risk models for adverse outcome may be used for treatment decisions in the elderly, but are often not designed to predict patient related outcome measures and do not include frailty characteristics.

详细描述

Multicentre, prospective, observational cohort study with a follow up time of one year. After initial diagnosis of CRC subjects will be screened for frailty using validated questionnaires, physical tests and non-invasive measurements. Frailty characteristics and HRQL are determined by Geriatric 8 (G8), Hospital Anxiety and Depression Scale(HADS), Euroqol- 5 dimensional (EQ-5D), Lawton Instrumental Activity of Daily Living scale(IADL), Mini Nutrition Assessment (MNA), 6 Item Cognitive Impairment Test (6-CIT), Identification of Seniors At Risk - Hospitalized Patients(ISAR-HP) and the EORTC-QLQ-C30/CR29 (HRQL in CRC patients). Physical tests include the Timed to Get Up (TUG) test and the hand grip strength test. Furthermore, the non-invasive measurements consist of a sarcopenia analysis using an existing CT/MRI scan and measurement of Advanced Glycation Endproducts (AGE reader).

Additional patients characteristics including medication use, medical history, tumor characteristics, neoadjuvant therapy and laboratory results of preoperative routine blood sampling will be collected. At three, six and twelve months after diagnosis, EORTC QLQ-C30/EORTC QLQ-CR29 and EQ-5D questionnaires are used to determine HRQL and disability free survival.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Age ≥ 70 years
  • Histologically proven non-metastatic colorectal cancer
  • Signed informed consent

排除标准

  • - Emergency surgical procedures
  • Insufficient understanding of the Dutch language

结局指标

主要结局

Loss of health related quality of life (HRQL)

时间窗: 12 months

Change in EORTC QLQ-C30

次要结局

  • Postoperative complications(30 days)
  • Loss of health related quality of life (HRQL)(3 months)
  • Disability(12 months)

研究者

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

dr. P. Noordzij

Principal Investigator

St. Antonius Hospital

研究点 (6)

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