Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. This study will assess Sentinel's feasibility and acceptability.
详细描述
Patients hospitalized for hematopoietic cell transplantation (HCT) experience physical and psychological symptoms that lead to a deterioration in quality of life (QOL). Integrating specialty palliative care (PC) reduces physical and psychological symptom burden and improves QOL during HCT hospitalization. However, specialty PC remains unavailable and underused at many HCT centers. Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. We will train HCT clinicians to deliver PC to patients before and during HCT hospitalization. This study will assess Sentinel's feasibility and acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years or older
- •Undergoing autologous or allogeneic HCT at MGH
排除标准
- •Prior receipt of inpatient specialty palliative care on two prior admissions in the past 6 months.
- •Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or ability to participate in study procedures
- •Inability to comprehend English as this is a preliminary/pilot study
研究组 & 干预措施
Sentinel, primary palliative care intervention
All participants will receive Sentinel, a primary palliative care intervention, in this single-arm feasibility trial. Participants will complete patient-reported assessments at the following time points:
- Baseline (prior to HCT admission)
- Week-2 of HCT hospitalization (+/- 3 business days)
- 1 month post-HCT (+/- 7 business days)
- 3 months post-HCT (+/- 7 business days)
干预措施: Primary palliative care (Behavioral)
结局指标
主要结局
Feasibility
时间窗: Up to Day 90
We will assess feasibility of Sentinel based on the proportion of eligible patients who enroll and the proportion of enrolled patients retained. Sentinel will be deemed feasible if at least 60% of eligible patients are enrolled in the study and patient retention through study procedures is at least 80%, commonly utilized metrics in PC trials
次要结局
- Acceptability(At Day 30)
研究者
Richard Andrew Newcomb, MD
Principal Investigator
Massachusetts General Hospital