H.O.P.E. Healing Optimization Through Preoperative Engagement: A Prospective Single Cohort Study to Evaluate the Effect of a Prehabilitation Program on Preoperative Outcomes in Upper GI Surgical Oncology Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Frailty Measurement
研究概览
简要总结
A one-group prospective cohort study design with measures collected pre- and post-intervention. The primary goal of this study is to evaluate the effect of a multimodal prehabilitation preoperative program on changes in frailty in upper gastrointestinal surgical oncology patients.
详细描述
Cancer patients often develop protein calorie malnutrition, inflammatory states, and loss of lean muscle mass, which can be best categorized as frailty. Frailty affects global health, the ability to carry out normal functions, and even the ability to tolerate targeted curative treatments such as surgery, chemotherapy, and radiation. The Investigators evaluate frailty, and design a study to evaluate the outcomes of the administration of multimodal preoperative prehabilitation programs on those frailty markers. Previous data provides support for interventions that include:
- Improved protein rich nutrition with specific immunonutrition recommendations,
- Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,
- Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and
- Disease specific education
These interventions should improve frailty by maintaining or regaining weight, improved grip strength, and improved prealbumin. These markers indicate improvements in nutritional status, increased strength and ability to ambulate, and improved functional status in the preoperative period. Other outcomes that will be reported include fat-soluble vitamin levels, global health, and inflammation.
The preoperative period is the best time to facilitate patient engagement through self-care and proactive activity. Interventions must be easy to accomplish and structured so patients have accountability and both patients and clinicians have methods and tools for measuring progress. Most patients and family members are motivated at this time and understand the need to improve frailty and potentially improve global health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be patients of Ochsner being seen at the Ochsner Medical Center (OMC).
- •All patients must be 25 to 80 years of age.
- •All patients must have a diagnosis of cancer.
- •> 10 pound unintentional weight loss within 1 year
- •Ability to perform grip strength test and Timed Up and Go (TUG) test
- •Willingness to participate in the study, document compliance, and attend clinical appointments
- •All patients must be undergoing one of the following major elective surgical oncologic resections with curative intent:
- •Pancreaticoduodenectomy for pancreatic cancer
- •Distal pancreatectomy / splenectomy for pancreatic cancer
- •Esophageal robotic assisted laparoscopic thoracoscopic esophagectomy for esophageal cancer
- •Laparoscopic or open, partial or total gastrectomy for gastric cancer
排除标准
- •All patients not undergoing oncologic or major resections.
- •All patients unwilling or unable to answer questionnaires or accept help to answer electronic or paper questionnaires.
- •All patients that are unable to participate in an activity program.
- •All patients unable to wear an electronic activity monitoring device.
- •All patients not wanting to follow a specific nutritional and breathing intervention.
- •All patients that are not able or wishing to consent.
研究组 & 干预措施
Frail
Subjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
干预措施: Nutritional Intervention (Combination Product)
Frail
Subjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
干预措施: Physical Activity Intervention (Behavioral)
Not Frail
Subjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
干预措施: Nutritional Intervention (Combination Product)
Not Frail
Subjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
干预措施: Physical Activity Intervention (Behavioral)
结局指标
主要结局
Frailty Measurement
时间窗: 4 Weeks
Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level
次要结局
- Vitamin levels(4 Weeks)
- Quality of Life (QoL) Assessment(4 Weeks)
研究者
Siobhan Trotter
Nurse Practitioner, Preoperative Optimization Program, Surgical Oncology and General Surgery
Ochsner Health System
