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

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer; Pancreatic Cancer; Esophageal Cancer
• Intervention / Treatment: Combination product: Nutritional Intervention; Behavioral: Physical Activity Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70471
      • Ochsner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Combination product: Nutritional Intervention; Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency; Other Names: Immunonutrition; Behavioral: Physical Activity Intervention; Walking and Inspiratory Muscle Training
Active Comparator: 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	Combination product: Nutritional Intervention; Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency; Other Names: Immunonutrition; Behavioral: Physical Activity Intervention; Walking and Inspiratory Muscle Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty Measurement	Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level	4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin levels		4 Weeks
Quality of Life (QoL) Assessment	QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health	4 Weeks

Collaborators and Investigators

• Sponsor: Siobhan Trotter
• Investigators: Principal Investigator: Siobhan M Trotter, DNP, Ochsner Health System

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Frailty; Prehabilitation
• Other Study ID Numbers: HOPE Study 2018.045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No