Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
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
- Rates of study enrollment
研究概览
简要总结
The goal of this research is to study an intervention, which the investigators call "Supportive Oncology Care at Home," that entails both remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs, and body weight) and a Medically Home care model (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified). Specifically, the investigators will conduct a single arm pilot study (N=20) in patients with pancreatic cancer who sign consent for parent trial of neoadjuvant FOLFIRINOX (18-179) receiving preoperative FOLFIRINOX to assess the feasibility and acceptability of Supportive Oncology Care at Home.
详细描述
Preoperative treatment can cause significant morbidity and often result in hospitalizations. Patients receiving preoperative FOLFIRINOX often experience numerous side effects, including nausea, vomiting, diarrhea, fatigue, fever, neuropathy, and loss of appetite. Frequently, patients require hospital admissions to help address uncontrolled symptoms related to their cancer and side effects related to the treatment,
Interventions targeting patients' symptoms and delivering care to patients at their homes have the potential to improve patient outcomes. Studies show that interventions targeting patients' symptoms can improve symptom management, enhance quality of life (QOL), and prevent hospitalizations.
Medically Home interventions have shown the potential to enhance patient outcomes. The Medically Home model of care is an alternative to a hospital admission for acute care and treatment of a clinical condition. Medically Home interventions entail providing medical care to acutely ill patients in their home. In addition, research in the general medicine literature has demonstrated that interventions involving remote patient monitoring with 'triggers' for visits to patients' homes for worrisome symptoms can enhance care outcomes.
Although this research demonstrates promising results, these studies have not been conducted among patients with cancer. Notably, the prior work involving home monitoring with visits as needed has lacked patient-reported outcomes, such as symptom monitoring. Thus, efforts are needed to develop and test interventions containing both symptom monitoring and the potential for home visits when necessary in a population of patients with cancer.
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 or older
- •Within three weeks of signing consent for parent trial of neoadjuvant FOLFIRINOX
- •Planning to receive care at Massachusetts General Hospital
- •Ability to read and respond to questions in English
- •Residing within 50 miles of Massachusetts General Hospital
排除标准
- •Uncontrolled psychiatric illness or impaired cognition
结局指标
主要结局
Rates of study enrollment
时间窗: 2 years
Proportion of patients who agree to participate in the study and sign informed consent.
Rates of completion
时间窗: 2 years
Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment.
次要结局
- Rates of completion of daily vital signs(2 years)
- Number of phone calls required(2 years)
- Rates of completion of weekly body weight(2 years)
- Number of emails required(2 years)
- Number of cycles of FOLFIRINOX received(2 years)
- Rates of completion of daily symptom monitoring(2 years)
- Number of home visits required(2 years)
- Change in symptom burden longitudinally throughout the study(2 years)
- Change in quality of life longitudinally throughout the study(2 Years)
- Number of treatment delays(2 years)
- Patient acceptability(2 years)
- Family caregiver acceptability(2 years)
- Clinician acceptability(2 years)
- Number of emergency department visits(2 Years)
- Number of urgent visits(2 Years)
- Number of hospital admissions(2 Years)
- Change in psychological distress(2 years)
- Cumulative dose of FOLFIRINOX received(2 years)
研究者
Ryan Nipp
Primary Investigator
Massachusetts General Hospital