A Multi-Center Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (the PERIOP-PC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 5
- 主要终点
- Patient Quality of Life Patient Quality of Life 12 Weeks After Surgery
研究概览
简要总结
The study goal is to compare surgeon-palliative care team co-management, versus surgeon alone management, of patients and family members preparing for major upper gastrointestinal cancer surgery. The study also aims to explore, using qualitative methods, the impact of surgeon-palliative care team co-management versus surgeon alone management on the perioperative care experience for patients, family members, surgeons, and palliative care clinicians.
详细描述
The components of surgeon palliative care team co management practices will include Time, Education, Assessments, and Multi disciplinary (TEAM) element.
- Time; At least 60 minutes/month (per patient and caregiver preference) devoted to palliative care treatments for the patient and family
- Education - Patients and family members, per their desires and wishes, are counseled and educated about their disease, including self-management of symptoms, prognosis, and treatment options
- Assessment - Formal assessment of symptoms including pain, dyspnea, constipation/diarrhea, anxiety/depression, fatigue, and nausea. Edmonton symptom score33 will be used as a formal assessment.
- Multi-Disciplinary - Management must be multi disciplinary with access to a multi-disciplinary palliative care team composed of nurse, physician, social worker, pharmacist, and/or chaplain team members.
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
- •18 years of age and must be able to give informed consent.
- •Diagnosed with pancreatic cancer or hepatocellular cancer or esophageal cancer or gastric cancer and/or cholangio carcinomas
- •Non emergent, upper gastrointestinal cancer related surgery with a goal of primary resection of the tumor- optimal surgical goal is cure, not merely disease palliation.
- •One companion per patient will be allowed to participate. In addition, to being identified by the patient at being a key caregiver throughout the surgery period, these companions must be able to give informed consent and at least 18 years of age.
排除标准
- •No previous involvement of palliative care providers in their care course
研究组 & 干预措施
Surgeon-palliative care team co-management
In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery.
干预措施: Surgeon-palliative care team co management (Other)
Surgeon alone management
The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended
干预措施: Surgeon team alone management (Other)
结局指标
主要结局
Patient Quality of Life Patient Quality of Life 12 Weeks After Surgery
时间窗: Up to 12 weeks after surgery
Patient quality of life will be measured by the Functional Assessment of Chronic Illness Therapy Palliative care subscale (FACIT-PAL). FACIT-PAL is a compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. FACIT-PAL has 46 item self report measure. The range is from 0-184 for the FACIT-PAL. A higher score is a better outcome.
次要结局
- Patient Mortality up to 6 Months(Up to 6 months after surgery)
- Patient Mood Symptoms Assessment 12 Weeks After Surgery(Up to 12 weeks after surgery)
- Patient Palliative Symptoms Assessment(Up to 12 weeks after surgery)
- Patient Spiritual Assessment 12 Weeks After Surgery(Up to 12 weeks after surgery)
- Patient Prognostic Awareness Assessment Assessment 12 Weeks After Surgery(Up to 12 weeks after surgery)
- Caregiver Burden Measurement 12 Weeks After Surgery(Up to 12 weeks after surgery)
- Caregiver Spiritual Measure at 12 Weeks(Up to 12 weeks after surgery)
- Caregiver Mood Symptom Assessment at 12 Weeks After Surgery(Up to 12 weeks after surgery)
- Caregiver Prognostic Awareness Assessment at 12 Weeks(Up to 12 weeks after surgery)
研究者
Karl Lorenz
Professor of Medicine (Primary Care and Population Health)
Stanford University