跳至主要内容
临床试验/NCT05187845
NCT05187845已完成不适用

Geriatrisch-Onkologische Studie Zur Lebensqualität Und Selbstständigkeit Nach Radiotherapie Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2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
20
试验地点
1
主要终点
Radiation associated changes in the independence in the activities of daily living

研究概览

简要总结

Elderly patients * with multiple comorbidities are underrepresented in most radio-oncology studies. In times of individualized therapy and when weighing up oncological over- or under-therapy, this observational study is a step towards the implementation of established geriatric instruments and concepts in radiation oncology. As part of the initial outpatient consultation on radiotherapy, the quality of life of patients older than 70 years before the start of therapy is assessed using the EORTC QLQ-C30 and ELD14 questionnaires. Furthermore, a geriatric screening is carried out using the G8 questionnaire. The geriatric screening carried out in routine clinical practice with little effort is used to filter out patients with no risk of increased vulnerability - these participants do not require any further examinations.

详细描述

Vulnerable patients with deficits (G8 score <15 pts) receive a geriatric assessment (Comprehensive geriatric assessment (CGA)) consisting of abbreviated comprehensive geriatric assessment (aCGA), appetite (Mini Nutritional Assessment (short form = MNA-SF)) at the beginning and end of radiotherapy ), physical functionality (Short physical performance battery) and measurement of hand strength. In addition, these patients receive an individualized inpatient geriatric-oncological complex treatment, which is already implemented analogous to the palliative complex treatment. The patients receive targeted support from trained nursing staff, social services, physiotherapy, nutritional advice, hospital pharmacies and psycho-oncology. At the end of the oncological therapy and for the first aftercare after the end of therapy, the questionnaires on quality of life are filled out again in order to analyze changes. Initially, 20 patients are to be treated in a first phase (feasibility) in this concept of geriatric-oncological complex treatment in order to build up and expand the necessary structures for an interdisciplinary complex treatment and to set parameters for adherence to the therapy concept and maintaining quality of life and independence in the activities of the daily life for this collective of patients. As part of a follow-up study, vulnerable patients are then to be stratified and randomized using these parameters so that a more detailed analysis is possible.

研究设计

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

入排标准

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

入选标准

  • Age from 75 years
  • G8-Screening <15Pkt
  • Potentially curative radiotherapy

排除标准

  • no written informed consent
  • life expectancy< 6 month

结局指标

主要结局

Radiation associated changes in the independence in the activities of daily living

时间窗: upt to 6 month after radiotherapy

Changes in the Barthel Index

Compliance to radiotherapy treatment

时间窗: through treatment time of radiotherapy, an average of 6 weeks

number of Events of premature termination of planned radiotherapy treatment

次要结局

  • Therapy associated toxicity(up to 6 month after radiotherapy)
  • Analysis of prognostic factors for radiotherapy Treatment success(up to 6 month after radiotherapy)

研究者

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

Juergen Debus

Department Director

University Hospital Heidelberg

研究点 (1)

Loading locations...

相似试验