Intrathecal Targeted Drug Delivery for Cancer Associated Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Pain Interference from Screening through 3-Months
研究概览
简要总结
This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.
详细描述
This is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. Subjects with cancer associated pain who are receiving conservative medical management (CMM) only and cancer patients receiving Intrathecal Drug Delivery system (IDDs) along with CMM will be followed for up to 3 months. Subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the IDDs group and start of the new treatment plan for the CMM group. Subjects that decide to cross-over to the IDDs group in a future date, will still be followed for their progress.
Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3- and 6- months post-implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 21 and older
- •Uncontrolled cancer-associated pain (pain score of >5 on NRS) despite oral use of 60 mg/d morphine equivalent a week prior to screening
- •Adverse side effects from long term opioid use defined as limiting or severely affecting patient's day to day function
- •Life expectancy of > 3 months
排除标准
- •Active infections
- •Controlled pain without adverse side effects that are limiting day to day function
- •Mechanical barriers
- •Obstruction of Cerebrospinal Fluid (CSF)
结局指标
主要结局
Change in Pain Interference from Screening through 3-Months
时间窗: 3-Months
Change from baseline to Month 3 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Change in Pain Intensity from Screening through 3-Months
时间窗: 3-Months
Change from baseline to Month 3 post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)
次要结局
- Change in Patient Well-Being(3-Months)
- Change in Patient Global Impression Change(3-Months)
- Change in Drug Adverse Levels(3-Months)
- Change in Healthcare Utilization(3-Months)
- Change in Oral Opioid Intake(3-Months)