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

NCT ID: NCT03642093

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-05-31

Brief Summary

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.

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.

Conditions

Pancreatic Cancer; Esophageal Cancer; Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Nutritional Intervention

Intervention Type: COMBINATION_PRODUCT

Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency

Physical Activity Intervention

Intervention Type: BEHAVIORAL

Walking and Inspiratory Muscle Training

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

Group Type: ACTIVE_COMPARATOR

Nutritional Intervention

Intervention Type: COMBINATION_PRODUCT

Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency

Physical Activity Intervention

Intervention Type: BEHAVIORAL

Walking and Inspiratory Muscle Training

Interventions

Nutritional Intervention

Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency

Intervention Type: COMBINATION_PRODUCT

Physical Activity Intervention

Walking and Inspiratory Muscle Training

Intervention Type: BEHAVIORAL

Other Intervention Names

Immunonutrition

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siobhan Trotter

OTHER

Sponsor Role: lead

Responsible Party

Siobhan Trotter

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Siobhan M Trotter, DNP

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

Ochsner Medical Center

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

HOPE Study 2018.045

Identifier Type: -

Identifier Source: org_study_id