Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- 30-second chair stand test (30s-CST)
研究概览
简要总结
The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.
The main aim of the study us to see if the functional decline in this group can be reduced.
详细描述
This is a randomized, controlled trial on frail older patients (aged 65 years or older) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Physiotherapist assessing function status.
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
- •elective surgery for colorectal cancer
- •ability to read and speak danish (informed concent)
排除标准
- •any physical condition that hinder physical exercise (eg. no legs)
- •not able to concent
结局指标
主要结局
30-second chair stand test (30s-CST)
时间窗: baseline to 14 weeks after surgery
functional test measuring lower body strength
次要结局
- number of patients to start up of adjuvant chemotherapy after surgery.(14 weeks)
- physical function and capacity - hand grip strength(baseline to 14 weeks after surgery)
- Patient reported Quality of Life: EORTC(baseline to 14 weeks after surgery)
- Postoperative complications(30 days + 90 days)
- number of series of adjuvant chemotherapy(14 weeks)
- physical function and capacity - 6-minute-walk-test(baseline to 14 weeks after surgery)
- inflammatory biomarker - CRP(baseline to 14 weeks after surgery)
- inflammatory biomarkers immuno-oncology(baseline to 14 weeks after surgery)
- doses of adjuvant chemotherapy(14 weeks)
- physical function and capacity - 6-meter gait speed(baseline to 14 weeks after surgery)
- Quality of recovery after surgery: questionnaire(1 day before surgery (baseline) to 3 days after surgery)
- inflammatory biomarker YKL-40(baseline to 14 weeks after surgery)
- survival(10 years)
- Patient reported Quality of Life: EORTC ELD14(baseline to 14 weeks after surgery)
- inflammatory biomarker - Interleukin 6(baseline to 14 weeks after surgery)
- sarcopenia biomarker GDF-11(baseline to 14 weeks after surgery)
- sarcopenia biomarker GDF(baseline to 14 weeks after surgery)
- readmission(30 days after surgery and 90 days after surgery)
- mortality(baseline to 3 months)
- start up time of adjuvant chemotherapy after surgery(14 weeks)
- body composition(baseline to 14 weeks after surgery.)
研究者
Troels Gammeltoft Dolin
MD, Principal Investigator, Department of internal Medicine
Herlev and Gentofte Hospital