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HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery (HOPE)

2018年9月7日 更新者:Siobhan Trotter

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (预期的)

60

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Louisiana
      • New Orleans、Louisiana、美国、70471
        • Ochsner Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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
Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
其他名称:
  • Immunonutrition
Walking and Inspiratory Muscle Training
有源比较器: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
Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
其他名称:
  • Immunonutrition
Walking and Inspiratory Muscle Training

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Frailty Measurement
大体时间:4 Weeks
Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level
4 Weeks

次要结果测量

结果测量
措施说明
大体时间
Vitamin levels
大体时间:4 Weeks
4 Weeks
Quality of Life (QoL) Assessment
大体时间:4 Weeks
QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health
4 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Siobhan M Trotter, DNP、Ochsner Health System

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年8月1日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2019年5月1日

研究注册日期

首次提交

2018年6月20日

首先提交符合 QC 标准的

2018年8月20日

首次发布 (实际的)

2018年8月22日

研究记录更新

最后更新发布 (实际的)

2018年9月11日

上次提交的符合 QC 标准的更新

2018年9月7日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • HOPE Study 2018.045

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Nutritional Intervention的临床试验

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