跳至主要内容
临床试验/NCT00552552
NCT00552552Unknown不适用

Development and Evaluation of a Cancer-Related Fatigue Patient Education Program

University of Bremen0 个研究点目标入组 300 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
Fatigue

研究概览

简要总结

The objective of this study is to develop a structured and evidence-based self-management program to cope with cancer-related fatigue and to assess the efficacy of the intervention in cancer survivors.

详细描述

Background

Cancer-related fatigue (CRF) and its impact on patients quality of life has been an increasing subject of research. However, in Germany exists a lack of evidence-based interventions consistent with the multidimensional character of fatigue. The objective of this study is to develop and evaluate a self-management program for disease-free cancer patients to cope with CRF.

Methods

Based on evidence extracted from a literature review a curriculum for the self-management program was elaborated. The curriculum is currently being reviewed and validated by an expert group of oncologists, psycho-oncologists, nurses, social workers, physical therapists, health scientists, and patients. The modules will be pretested with a small number of patients, discussed in terms of feasibility and acceptance.

To determine the efficacy of the program a randomised controlled trial will be conducted: 300 patients will be allocated to an intervention or a waiting control group. Data will be collected before randomisation, after intervention, and after a follow-up of 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

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

  • malign neoplasms
  • ECOG performance status of 0-2
  • moderate or severe fatigue
  • stable condition after treatment
  • German speaking

排除标准

  • life expectancy < 1 year
  • patients with brain neoplasms
  • suicidal tendencies
  • severe psychiatric disorders

结局指标

主要结局

Fatigue

时间窗: Baseline, after the intervention, 6 months later

次要结局

  • Quality of Life, Depression and anxiety, physical activity(Baseline, after the intervention, 6 months later)

研究者

发起方
University of Bremen
申办方类型
Other

相似试验