A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- trial feasibility
研究概览
简要总结
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.
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:
- •Adults (≥ 18 years old)
- •Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
- •Planning to receive continued care from an oncologist at the Hillman Cancer Center
- •Accompanied by a caregiver (family member or friend) at the first visit
- •Caregivers:
- •Adults (>= 18 years old)
- •Family member or friend of an eligible patient
排除标准
- •Patients:
- •Unable to read and respond to questions in English
- •Not planning to receive continued care from an oncologist at the Hillman Cancer Center
- •Pancreatic neuroendocrine cancer
- •Caregivers:
- •Unable to read and respond to questions in English
结局指标
主要结局
trial feasibility
时间窗: up to 2 years
We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
acceptability of intervention participation
时间窗: 3 months (+/- 3 weeks) from patient enrollment
We will report the percentage of patients and caregivers who found the intervention acceptable.
intervention fidelity
时间窗: Up to 2 years
We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
perceived effectiveness
时间窗: 3 months (+/- 3 weeks) from patient enrollment
We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.
次要结局
- change in patient quality of life(baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment)
- patient healthcare utilization(up to 2 years)
- patient quality of life(3 months (+/- 3 weeks) from patient enrollment)
研究者
Yael Schenker, MD, MAS
Assistant Professor of Medicine
University of Pittsburgh