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临床试验/NCT03642093
NCT03642093Unknown4 期

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

Siobhan Trotter1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

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:

  1. Improved protein rich nutrition with specific immunonutrition recommendations,
  2. Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,
  3. Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and
  4. 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

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

发起方
Siobhan Trotter
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Siobhan Trotter

Nurse Practitioner, Preoperative Optimization Program, Surgical Oncology and General Surgery

Ochsner Health System

研究点 (1)

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