NCT01278537已完成不适用
Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 690
- 试验地点
- 6
- 主要终点
- Length of hospital stay
研究概览
简要总结
The aims of this study are to investigate whether patient empowerment, including information and decision-aids adapted to the risk and the need of the elderly patient, can improve outcome in an evidence-based modular pathway in terms of
- shortened hospital stay by a reduced postoperative complication rate and
- quality of life in elderly patients compared to control patients receiving standard of care.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years and older with abdominal, thoracical or urogenital cancer scheduled for surgery
- •Offered patient information and written informed consent
- •Confirmed cancer diagnosis via histology
- •Mini Mental state > 23
- •Life-expectance > 2 months
排除标准
- •Participation in another trial according to the German Drug Law 7 days to and 7 days after the operation during the study
- •No informed consent
- •Emergency patients
- •Lacking willingness to save and hand out data within the study
- •Accommodation in an institution due to an official or judicial order
- •Concurrent malignancies
- •Insufficient knowledge of the German language
- •In case of the inclusion of a PERATECS - study patient in an adjuvant therapy study during the study period, the patient will be excluded from the PERATECS-study
结局指标
主要结局
Length of hospital stay
时间窗: within the first month
Quality of life
时间窗: within the first year
次要结局
- Readmission rate(within the first three months)
- Short-term complications(within the first months)
- Overall mortality(within one year)
- Depression(within the first year)
- Stress(within the first month)
研究者
Claudia Spies
Univ. Prof. Dr. med. Claudia Spies
Charite University, Berlin, Germany
研究点 (6)
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