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