Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Reduction in depression score
研究概览
简要总结
Effect of Early management on PAin and DEpression in patients with PancreatoBiliary Cancer, EPADE-PB
Purpose
To determine whether early palliative care integrated with usual oncologic care with automated symptom monitoring can improve depression and pain in patients with cancer
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 (Outcomes Assessor)
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
- •Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
- •Pathologic confirmed locally advanced or metastatic pancreatic cancer or biliary tract cancer
- •within 8 weeks after diagnosis
- •cancer-related pain (Brief Pain Inventory [BPI] worst pain score >3), depression (Center for Epidemiological Studies-Depression Scale [CES-D] >16) or both
- •Karnofsky Performance Rating Scale ≥50%
排除标准
- •Opioid intolerance
- •History of drug or alcohol abuse
- •Impaired sensory or cognitive function
- •Pregnant or lactating woman
- •Women of child bearing potential not using a contraceptive method
- •Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
研究组 & 干预措施
Contol: usual oncologic care
Patients randomly assigned to usual oncologic care were not scheduled to meet with the palliative care service unless a meeting was requested by the patient, the family, or the oncologist; those who were referred to the service did not cross over to the early palliative care group or follow the specified palliative care protocol.
Early Palliative care
The interventions consisted of the following:
(1) Nursing assessment of pain and depression mood (2) Pain control based NCCN guideline (3) Depression control by psychoeducation and/or consultation of psychiatrist specialist (4) Patient education
干预措施: Early Palliative care integrated with usual oncologic care (Other)
结局指标
主要结局
Reduction in depression score
时间窗: at baseline, 1 month, and every 3 months, up to 1 year
Reduction in depression score, Center for Epidemiological Studies-Depression Scale \[CES-D\]
Reduction in pain score
时间窗: at baseline, 1 month, and every 3 months, up to 1 year
• Reduction in pain scores, Brief Pain Inventory \[BPI\] severity
次要结局
- Quality of life(at baseline, 1 month, and every 3 months, up to 1 year)
- Overall survival(at baseline, 1 month, and every 3 months, up to 1 year)
研究者
Sang Myung Woo
Staff physician, Ceneter for Liver Cancer
National Cancer Center, Korea