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

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ClinicalTrials.gov Identifier: NCT03642093
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Siobhan Trotter, Ochsner Health System

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Esophageal Cancer Gastric Cancer Combination Product: Nutritional Intervention Behavioral: Physical Activity Intervention Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Immunonutrition

Behavioral: Physical Activity Intervention
Walking and Inspiratory Muscle Training




Primary Outcome Measures :
  1. Frailty Measurement [ Time Frame: 4 Weeks ]
    Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level


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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642093


Locations
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United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70471
Sponsors and Collaborators
Siobhan Trotter
Investigators
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Principal Investigator: Siobhan M Trotter, DNP Ochsner Health System

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Responsible Party: Siobhan Trotter, Nurse Practitioner, Preoperative Optimization Program, Surgical Oncology and General Surgery, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03642093     History of Changes
Other Study ID Numbers: HOPE Study 2018.045
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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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
Keywords provided by Siobhan Trotter, Ochsner Health System:
Frailty
Prehabilitation