HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 25 - 80 |
| Updated: | 9/13/2018 |
| Start Date: | August 1, 2018 |
| End Date: | May 2019 |
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.
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.
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.
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.
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.
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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