Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- Quality of life measured by the EORTC QLQ C-30
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the standardized care pathway which provides enhanced supportive care for patients with advanced cancer.
A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of applying standardized care pathway to provide enhanced supportive care. A Randomized Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to intervention arm (receiving enhanced supportive care according to the standardized care pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the intervention arm will receive enhanced supportive care consisted of symptom management and coping enhancement counseling for 5 times. Data from advanced cancer patients will be collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm), at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as advanced cancer patients' symptom, coping and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult (age >=19 years old),
- •cancer patients and their family
- •ECOG =<2
排除标准
- •patients with cognitive or psychiatric issue
结局指标
主要结局
Quality of life measured by the EORTC QLQ C-30
时间窗: at the visit for cycle 5 of chemotherapy (at average 3 month)
Coping measured by brief COPE
时间窗: at the visit for cycle 5 of chemotherapy (at average 3 month)
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
时间窗: at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)
次要结局
- Self-efficacy measured by the Cancer Behavior Inventory 3.0(at 6 month)
- Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation(at 6 month)
- Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver(at 6 month)
- Coping measured by brief COPE(at 6 month)
- Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month(At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month))
- Survival(at 12 month)
- Quality of life measured by the EORTC QLQ C-30(at 6 month)
- Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month(At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month))
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)(at 6 month)