Surgery for Cancer With Option of Palliative Care Expert: A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Physical and Functional Quality of Life as Measured by the FACT-G TOI
研究概览
简要总结
Frequently people diagnosed with cancer experience physical and emotional symptoms during the course of their disease. These symptoms can be very distressing to both the patient and the family members. The study doctor wants to know if the introduction of a team of clinicians that specialize in the lessening of many of these distressing symptoms may improve your overall care. This team of clinicians is called the palliative care team and they focus on ways to improve your pain and other symptom management (i.e. shortness of breath, fatigue, anxiety, etc.) and to assist you and your family in coping with the emotional, social, and spiritual issues associated with your diagnosis. The team consists of physicians, advanced practice nurses, case managers, and nurses who have been specially trained in the care of patients facing serious illness.
This research study is being done because although many people with cancer receive palliative care late in the course of their illness, the study team thinks palliative care may be more useful when it is started earlier and in this case before surgery. The main purpose of this study is to compare two types of care -usual surgery and cancer care and usual surgery and cancer care with comprehensive palliative care services to see which is better for improving the experience of patients and families with cancer.
详细描述
The Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial is an investigation that will study the effect of a palliative care implementation during the preoperative, perioperative, and postoperative phase for adults undergoing cancer surgery for selected gastrointestinal and genitourinary malignancies. SCOPE will be a single-blind, single-institution randomized controlled trial of 236 patients. Intervention arm patients will receive a preoperative outpatient specialty palliative care consultation from a palliative care provider (physician or nurse practitioner) in addition to inpatient and outpatient palliative care follow-up postoperatively. Control arm patients will receive usual care with palliative care available at the discretion of the primary treatment team (currently these patients rarely get palliative care and usually only in the last weeks of life). The central hypothesis of the SCOPE Trial is that preoperative, perioperative, and postoperative specialty palliative care will improve patient functioning and quality of life in patients undergoing resection of selected GI and GU malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •adult patients (≥18 years old) scheduled for one of the following abdominal operations with intent to provide cure or durable oncologic control of malignancy:
- •Total or partial gastrectomy requiring anastomosis
- •Total or partial pancreatectomy
- •Partial hepatectomy
- •Colectomy or proctactomy if one of the following 3 conditions is also met:
- •i) patient age is 65 years or older ii) disease is metastatic iii) disease is locally invasive requiring extensive resection
- •Radical cystectomy
- •Pelvic exenteration
- •Abdominal debulking for ovarian or endometrial carcinoma
- •Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
排除标准
- •Non-English speaking patient
- •Residence >150 miles away from Vanderbilt and do not visit the Nashville area regularly
- •No telephone or otherwise unwilling/unable to complete follow-ups
- •Current enrollment in a study that does not allow co-enrollment or that uses a non-pharmacologic, non-procedural intervention directed at surgical or cancer care.
- •Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline
- •Inability to obtain informed consent from patient meeting all inclusion criteria for the following reasons:
- •Attending surgeon refusal
- •Patient refusal
- •Period of time between screening patient and time of operation does not allow preoperative outpatient palliative care visit.
- •Currently participating in palliative care or seeing a palliative care provider.
研究组 & 干预措施
Palliative Care Intervention
干预措施: Palliative Care Intervention (Behavioral)
Standard of Care
结局指标
主要结局
Physical and Functional Quality of Life as Measured by the FACT-G TOI
时间窗: 90 days after operation
FACT-Gastric Trial Outcome Index (TOI) is an efficient summary index of physical/functional outcomes and is comprised of two subscales from the FACT-Gastric Score: the physical wellbeing subscale (7 questions) and the functional wellbeing scale (7 questions). Each question uses a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Total scores on the FACT-TOI range from 0-56. The higher the score, the better the quality of life.
次要结局
- Overall Survival(1 year)
- Quality of Life as Measured by the FACT-G(90 days after operation)
- Days Alive at Home Without an Emergency Room Visit(90 days after operation)
- Post-Traumatic Stress Disorder (PTSD) Symptoms(180 days after operation)
研究者
Myrick C. Shinall, Jr., MD, PhD
Assistant Professor of Surgery
Vanderbilt University Medical Center