Preoperative, Specialty Palliative Care for Patients Considering Pancreatic Surgery: Pilot Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage of recruited patients that consent (acceptability)
研究概览
简要总结
This clinical trial evaluates a palliative care consultation for improving communication between providers and patients considering surgery for a pancreatic neoplasm. Pancreatic operations have known complications that can affect quality of life. Palliative care has been shown to improve patient reported quality of life and functional outcomes. Receiving a palliative care consultation may improve communication and decision making for patients considering surgery for a pancreatic neoplasm.
详细描述
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual care and undergo evaluation by a tumor board within 14 days of baseline.
ARM II: Patients attend a palliative care visit over 60 minutes to discuss their illness, quality of life, fears and concerns and communication preferences within 7 days of baseline. Patients also undergo evaluation by a tumor board within 14 days of baseline.
After completion of study intervention, patients are followed up 7 days after the tumor board visit and 90 days after initiation of treatment.
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
- •Adults (18 years or older)
- •Pancreatic neoplasm pathology
- •Ability to read, write, and speak in English
- •Has decisional capacity
- •Expected to be seen and discussed at PCSC and seeing a surgeon as part of their tumor board evaluation
排除标准
- •Metastatic pancreatic neoplasm
- •Currently incarcerated
- •Currently is or previously has received palliative care, or are unwilling to forego palliative care for the first 90 days post randomization
- •Evidence of any behavior, condition, or circumstance (including, but not limited to: blindness, deafness, serious behavior or mental health conditions, discontinuing curative treatment, lack of access to technology, etc) that would interfere with their ability to complete study procedures as noted within the chart
结局指标
主要结局
Percentage of recruited patients that consent (acceptability)
时间窗: At time of consent
Acceptability will be defined as ≥ 60% of recruited patients consented.
Percentage of patients randomized to the interventional arm who complete the palliative care consult prior to tumor board (feasibility)
时间窗: At time of multidisciplinary tumor board discussion (No more than 14 days after baseline)
Feasibility will be defined as ≥ 60% of patients randomized to interventional arm who complete palliative care consult prior to pancreatic cancer specialty clinic tumor board.
次要结局
- Percentage of participants who complete study measures within the first 90 days(At completion of 90 day follow-up timepoint)
- Percentage of participants randomized to usual care who go on to receive palliative care within the active study period(At 90 day follow-up timepoint)
- Percentage of participants who complete the decisional conflict scale(At completion of 7 day follow-up timepoint)