NCT03455023Unknown不适用
Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Inpatients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in medication adherence
研究概览
简要总结
The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients
详细描述
This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older;
- •Histologically confirmed solid tumor;
- •Diagnosed chronic cancer pain;
- •Opioid-tolerant patients;
- •Overall survival is expected to be over 3 months;
- •Karnofsky performance score≥50;
- •Willing and able to comply with the protocol
排除标准
- •Current pregnancy or breastfeeding;
- •Patients diagnosed with non-cancer pain;
- •Patients treated with patient-controlled analgesia;
- •Patients with pathological fracture, gastrointestinal obstruction, severe infection, non-opioid related intractable constipation;
- •Patients with mental disorder;
- •Creatinine clearance rate <15mL/min;
- •ALT or AST ≥ 10 fold of upper limit of normal value
结局指标
主要结局
Change in medication adherence
时间窗: Change from baseline at 1 month after discharge
The investigators will measure the change in medication adherence via Morisky Scale. Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.
次要结局
- Incidence of adverse events [safety and tolerability](Up to 1 month after discharge)
- Change in quality of life(Change from baseline at 1 month after discharge)
- Change in pain score(Change from baseline at 1 month after discharge)
- Change in patients' knowledge of cancer pain and analgesics(Change from baseline at 1 month after discharge)
研究者
Ping Huang
Chief of Pharmacy
Zhejiang Cancer Hospital
研究点 (1)
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